Risk Management Requirement Under MDR

30 Jul, 2020

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title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”1″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

EU MDR Risk Management Requirements

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]Navigating European Union Medical Device Regulations (EU MDR) 2017/745[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]EU MDR 2017/745 establishes strict requirements for risk management as part of the regulatory framework for medical devices and emphasizes the importance of a comprehensive risk management system. As per Article 10 of EU MDR, manufacturers are required to establish, document, implement and maintain a system for risk management. This process must be maintained and updated throughout the device’s entire lifecycle, including Post-Market Surveillance (PMS) and must be integrated into the manufacturer’s Quality Management System (QMS) to comply with ISO 13485:2016 or equivalent standards. The EU MDR states that risk management requirements also apply to the list of devices present in Annex XVI i.e., for devices without an intended medical purpose.[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

The following is the thirteenth in the series of EU MDR related blogs. To learn more about the EU MDR changes you can view some of the previous posts in the series:

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Risk management is a systematic process for identifying, evaluating, controlling, and monitoring risks associated with a medical device throughout its entire lifecycle. The EU MDR requires manufacturers to implement a robust risk management system as per ISO 14971 (Medical devices — Application of risk management to medical devices), and the technical report ISO/TR 24971 (Guidance on the application of ISO 14971). The ISO/TR 24971 provides guidance on the application of ISO 14971, the international standard for risk management of medical devices.

The risk management process described in ISO 14971 consists of several steps, as illustrated in Figure 1, which apply to the design, development and production of every medical device. Each of these steps need to be documented in procedures in the manufacturer’s organization.

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margin_left=”” bordersize=”” bordercolor=”” borderradius=”” z_index=”” caption_style=”below” caption_align_medium=”none” caption_align_small=”none” caption_align=”left” caption_title=”Figure 1: Risk Management Process described in ISO 14971 ” caption_text=”” caption_title_tag=”5″ fusion_font_family_caption_title_font=”” fusion_font_variant_caption_title_font=”” caption_title_size=”” caption_title_line_height=”” caption_title_letter_spacing=”” caption_title_transform=”” caption_title_color=”” caption_background_color=”” fusion_font_family_caption_text_font=”” fusion_font_variant_caption_text_font=”” caption_text_size=”” caption_text_line_height=”” caption_text_letter_spacing=”” caption_text_transform=”” caption_text_color=”” caption_border_color=”” caption_overlay_color=”” caption_margin_top=”” caption_margin_right=”” caption_margin_bottom=”” caption_margin_left=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ 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rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Key Risk Management Requirements Under the EU MDR[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” 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Lifecycle Integration

The EU MDR mandates that risk management must be embedded within the entire lifecycle of a medical device. This includes the initial design, manufacturing, clinical evaluation report, market release, and ongoing PMS. Manufacturers are required to continuously monitor and mitigate risks, adapt to new data and real-world performance of their devices.

General Safety and Performance Requirements (GSPRs)

Annex I Chapter I of the EU MDR outlines the General Safety and Performance Requirements (GSPRs) that all medical devices must meet (GSPR 2, 3, 4, 5 and 8). The regulation requires manufacturers to eliminate or reduce risks as much as possible, primarily through safe design and manufacturing processes. In addition, Annex I provides the order of priority that the manufacturers must consider while selecting the most appropriate solutions:

Eliminate or reduce risks as far as possible through safe design and manufacture
Adequate protection measures for risks that cannot be eliminated (e.g. alarms)
Provide information or user training for safety and disclose any residual risks

According to the EU MDR, the manufacturer “shall inform users of any residual risks”.

Benefit-Risk Analysis

A key aspect of EU MDR is the need for a thorough benefit-risk analysis. Manufacturers must demonstrate that the benefits of the device outweigh any residual risks. This analysis is crucial, especially for high-risk devices, and must be continually reassessed based on clinical data and post-market information.

As per the guidance, benefits are defined as the positive impact of the medical device on patient health or well-being. These can include therapeutic, diagnostic, and operational benefits. ISO/TR 24971 suggests considering both direct benefits (e.g., clinical improvement, life-saving interventions) and indirect benefits (e.g., improved quality of life, reduced need for other medical interventions). The standard does not prescribe a specific threshold for when benefits outweigh risks but instead suggests that this determination is context dependent. Manufacturers need to consider factors such as the severity of the medical condition being treated, the availability of alternative treatments, and the expectations of patients and healthcare providers.

ISO/TR 24971 provides detailed guidance on performing benefit-risk analysis, which is crucial when dealing with residual risks that cannot be further reduced. It provides illustrative examples/ various scenarios and considerations for special cases as detailed below:

Illustrative Examples: A life-saving device might have a different benefit-risk profile compared to a device that improves quality of life.
Scenarios with High Residual Risks: There could be scenarios where high residual risks may still be acceptable, such as in life-threatening conditions where no alternative treatments are available. It also explores situations where even low residual risks might be unacceptable if the benefits are minimal.
Vulnerable Populations: The need for special consideration when the device is intended for vulnerable populations, such as children, the elderly, or immunocompromised patients. The benefit-risk analysis in these cases should be particularly thorough and sensitive to the specific needs and vulnerabilities of these groups.
Innovative Devices: For innovative or novel medical devices, where clinical experience may be limited, a more cautious approach should be taken for benefit-risk analysis. Manufacturers should be prepared to adjust their analysis as new data becomes available through PMS.

The benefit-risk analysis should be revisited and updated as new information becomes available, particularly during PMS. Changes in the clinical environment, clinical investigations, new adverse event data, or updated clinical evidence can all influence the benefit-risk ratio.

Post-Market Surveillance (PMS) and Vigilance

Post-market surveillance is an ongoing process that feeds into the risk management system. Manufacturers must establish a PMS Plan that monitors the device’s performance and safety after it has been released to the market. PMS Report (PMSR) and Periodic Safety Update Report (PSUR) summarizes the results and conclusions of the PMS data analysis. The PMSR/PSUR must include a review of the benefit-risk analysis and should feed into the risk management process, ensuring that the new risks are identified and mitigated as necessary.

Documentation and Traceability

Comprehensive documentation is required to support the risk management process. This includes a plan, risk analysis, control measures, residual risk evaluation, and the benefit-risk analysis collated in the form of report as detailed below.

Risk Management Plan:
- The plan outlines the strategy for identifying and mitigating risks. It includes procedures for risk analysis, risk evaluation, and the implementation of risk control measures. The plan also defines the criteria for risk acceptability, aligned with the device’s intended use and the manufacturer’s policy.
Risk Analysis and Evaluation:
- Risk analysis involves identifying potential hazards associated with the device and assessing the severity and likelihood of these risks. Risk evaluation then compares these risks against predefined acceptability criteria to determine which risks require mitigation.
Risk Control Measures:
- Risk control involves implementing measures to reduce or eliminate identified risks. These measures can include design changes, protective features, or providing clear instructions for use. The goal is to reduce risks to an acceptable level, ensuring that any residual risks are outweighed by the device’s benefits.
Risk Management Report:

The report documents all risk management activities, including risk analysis, risk control, and the evaluation of residual risks. This report is a crucial part of the technical documentation required for regulatory submissions

As per Annex II of EU MDR, the technical file must contain all relevant risk management documentation, ensuring traceability and providing evidence of compliance.[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Interplay Between Clinical Evaluation and Risk Management[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]

Article 61 of EU MDR emphasize the requirement of conducting clinical evaluation and feeding the data to risk management. The clinical evaluation and risk management are deeply interconnected processes that must work together to ensure the safety and efficacy of medical devices.

Informed Risk Management Through Clinical Data:
- Clinical evaluation (EU MDR Annex XIV, Part A) provides the evidence needed to identify and assess risks accurately. The clinical data gathered through clinical evaluation informs the risk management process by highlighting potential hazards, side-effects, and other safety concerns that need to be addressed.
Benefit-Risk Analysis:
- One of the critical outcomes of the clinical evaluation is the benefit-risk analysis. This analysis compares the identified risks against the clinical benefits of the device. Risk management processes use this analysis to determine whether the device’s risks are acceptable and to justify the device’s continued use.
Feedback Loop Between Post Market Clinical Follow-up (PMCF) and Risk Management:
- PMCF (EU MDR Annex XIV, Part B) is a key aspect of both clinical evaluation and risk management. It provides ongoing data that can reveal new risks or confirm the effectiveness of risk control measures. This continuous feedback loop ensures that both clinical evaluation and risk management processes are updated and aligned with real-world device performance.
Documentation and Compliance:

Both clinical evaluation and risk management require thorough documentation, which is critical for regulatory compliance. The Clinical Evaluation Report (CER) and Risk Management Report must be aligned and should consistently demonstrate that the device meets the safety and performance standards established according to EU MDR.

[/fusion_text][fusion_imageframe image_id=”21531|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Article 61 of EU MDR – Risk Management Medical Devices” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” max_width=”” sticky_max_width=”” align_medium=”none” align_small=”none” align=”none” mask=”” custom_mask=”” mask_size=”” mask_custom_size=”” mask_position=”” mask_custom_position=”” mask_repeat=”” style_type=”” blur=”” stylecolor=”” hue=”” saturation=”” lightness=”” alpha=”” hover_type=”none” magnify_full_img=”” magnify_duration=”120″ scroll_height=”100″ scroll_speed=”1″ margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” 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highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Best Practices for Implementing ISO 14971 Under EU MDR[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” 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To successfully implement ISO 14971 and meet EU MDR requirements, manufacturers should consider the following best practices:

Start risk management early in development.
Involve cross-functional teams for a comprehensive risk assessment.
Use post-market data to inform risk decisions.
Maintain rigorous and traceable documentation.
Continuously monitor and update risk management processes.

The stringent requirements of the EU MDR for clinical evaluation and risk management are designed to ensure that medical devices are safe, effective, and provide a favorable benefit-risk profile.

Specialists in EU MDR Risk Management

If you have any questions or concerns about risk management for your medical device under the EU MDR then get in touch with us for a compliance consultation.

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Are you aware of statements regarding risk management, clinical performance, and clinical evaluation requirements in the context of the new MDR regulatory framework that must be considered? Depending on your product portfolio, Celegence can help you understand how to effectively undertake risk management activities to meet the new EU MDR vision and gain compliance. Reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device capabilities.

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Guidance on Addressing Cybersecurity of Connected Medical Devices

16 Jul, 2020

Guidance for Cybersecurity of Connected Medical Devices

“a state where information and systems are protected from unauthorized activities, such as access, use, disclosure, disruption, modification, or destruction to a degree that the related risks to confidentiality, integrity, and availability are maintained at an acceptable level throughout the life cycle.”

The general principles and best practices provided in the IMDRF document facilitates international regulatory convergence on medical device cybersecurity.

The guidance document covers six key recommendations for cybersecurity best practices:

Implement risk-based approaches for design and development of medical devices
Ensuring safety, performance, and security of devices as well as their connected healthcare infrastructures
Cybersecurity is to be considered as a shared responsibility among manufacturers, healthcare providers, regulators, and other stakeholders
Issuing recommendations to stakeholders to minimize risks of patient harm across a device’s total product life cycle
Establishing consistently defined cybersecurity terms as well as best practices for achieving and maintaining device cybersecurity
Developing and promoting broad data sharing policies regarding cybersecurity incidents, threats, and vulnerabilities

Global Harmonization: All medical device stakeholders are encouraged to harmonize their approaches to cybersecurity throughout the life cycle of the medical device. This encompasses harmonization across product design, risk management activities throughout the life cycle of the device, device labeling, regulatory submission requirements, information sharing, and post-market activities
Total Product Life Cycle (TPLC): From the initial conception to end of support (EOS), various risks associated with cybersecurity threats and vulnerabilities should be taken into consideration. The dynamic nature of cybersecurity risk can be effectively addressed by applying risk management throughout the TPLC
Shared Responsibility Among Stakeholders: Stakeholders involved in medical device cybersecurity should understand their responsibilities and work closely with other stakeholders to continuously monitor, assess, mitigate, communicate, and respond to potential cybersecurity risks and threats throughout the life cycle of the medical device
Promote Transparency Through Information Sharing: The TPLC approach to safe and secure medical devices uses cybersecurity information sharing as a corner stone. Information sharing can be achieved by adopting a pre- and post-market approach by the respective stakeholders

To ensure safe use of the medical device information relating to the security of medical devices should be shared with users, patients, other manufacturers, distributors, healthcare providers, security researchers, and the public
The shared information should be meaningful, consumable, and actionable for different stakeholders (e.g. information about a more secure chipset could be important across manufacturers, but the information may provide no benefit to end-users of the device)
Information should be appropriate and shared freely, with the aim of improving patient safety irrespective of commercial interests
Ensure providing globally consistent information that is shared synchronously across jurisdictions (as appropriate) to enable stakeholders in various jurisdictions to respond accordingly

Although medical device cybersecurity should be addressed throughout TPLC, some of the important pre-market elements that a manufacturer should address during the design and development of a medical device prior to market entry include:

Designing security features into the product
Application of accepted risk management strategies
Performing security testing
Provision of useful information for users to operate the device securely
A plan in place for post-market activities

[/fusion_text][fusion_imageframe image_id=”5798|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Cybersecurity Measures at the Pre-Market Stage – Celegence -Medical Device Cybersecurity Regulations” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/07/Cybersecurity-Measures-at-the-Pre-Market-Stage-Celegence-Medical-Device-Cybersecurity-Regulations.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Cybersecurity Measures at the Post-Market Stage[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

A post-market approach is necessary when pre-market controls designed and implemented may be inadequate to maintain an acceptable risk profile. The various elements that a post-market approach include are:

Operation of the device in the intended environment
Information sharing
Coordinated vulnerability disclosure
Vulnerability remediation
Incident response, and legacy devices

Device instructions and product specifications related to recommended cybersecurity controls appropriate for the intended use environment (e.g., anti-malware software, network connectivity configuration, use of a firewall)
Backup description, restore features and procedures to regain configurations
A list of network ports and other interfaces that are expected to receive and/or send data, and a description of port functionality and whether the ports are incoming or outgoing (note that unused ports should be disabled)
Sufficiently detailed system diagrams for end-users

The manufacturer must include technical documentation pertaining to installation, configuration of the device, technical requirements for their operating environments. This is particularly important for safe and secure use by the user. The information must entail the following elements:

Guidance to users regarding the supporting infrastructure requirements
Description of the device’s secure configuration that may include end point protections such as anti-malware, firewall/firewall rules, whitelisting, security event parameters, logging parameters, physical security detection, etc.
Technical instructions to permit secure network (connected) deployment and servicing, and instructions for users on how to respond upon detection of a cybersecurity vulnerability or incident, where appropriate
A description of how the device or supporting systems will notify the user when anomalous conditions are detected (i.e., security events), where feasible
A description of the methods for retention and recovery of device configuration by an authenticated privileged user
Where appropriate, security risks and consequences of changes to the security configuration, or to the use environment A description of systematic procedures for authorized users to download and install updates from the manufacturer
Information concerning device cybersecurity end of support
A Software Bill of Materials (SBOM) to inform and support operators regarding the cybersecurity of commercial, open source, or off-the-shelf software components which are included in the medical device

Requirement to document and summarize activities related to cybersecurity
Premarket authorization requires manufacturers to submit the device’s design features, risk management activities, testing, labeling and evidence of a plan to monitor and respond to emerging threats throughout the product’s life cycle in relation to cybersecurity

[/fusion_text][fusion_imageframe image_id=”5799|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Regulatory Submission Documentation by Manufacturers – EU MDR Medical Device Cybersecurity Regulations” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/07/Regulatory-Submission-Documentation-by-Manufacturers-EU-MDR-Medical-Device-Cybersecurity-Regulations.jpg[/fusion_imageframe][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Standards Included in the Guidance[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

The reference section of the IMDRF guidance cites 2 standards:

UL 2900-1:2017 covering software cybersecurity for network-connected medical devices
UL 2900-2-1:2017 for requirements particular to network-connectable healthcare and wellness system components

Inclusion of these standards in the guidance indicates that these standards have become trusted indicators of cybersecurity risk management for connected devices.

Celegence experts can provide you with an overview on the general principles of medical device cybersecurity, including a number of recommendations for stakeholders regarding best practices in the pre-market and post-market management of medical device cybersecurity.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”40px” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”10px” border_radius_top_right=”10px” border_radius_bottom_right=”10px” border_radius_bottom_left=”10px” box_shadow=”yes” box_shadow_vertical=”5%” box_shadow_horizontal=”5%” box_shadow_blur=”28″ box_shadow_spread=”2″ box_shadow_color=”#f1f6f8″ box_shadow_style=”” padding_top=”” padding_right=”0px” padding_bottom=”” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”#f6f8f8″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_builder_row_inner][fusion_builder_column_inner type=”1_1″ layout=”1_1″ spacing=”2%” center_content=”yes” hover_type=”none” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”10px” padding_right=”20px” padding_bottom=”0px” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” background_color=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

For further information on assessing cybersecurity hygiene of your medical device, or to learn more about the UL 2900 series of standards, reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device capabilities.

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Medical Device Labeling Changes and Challenges Under EU MDR

06 Jul, 2020

To learn more about the EU MDR changes you can view some of the previous posts in the series:

[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”15px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Product Labeling – EU MDR[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Labeling receives prominent attention in the new EU MDR/IVDR regulation that has been released to ensure high standards of quality and safety for medical devices being produced or supplied. Therefore, it is of paramount importance for regulatory, labeling and operational professionals to gain a clear understanding of the impact of the new regulations on labeling. This in turn can rescue manufacturers who are trying to manage product labeling and artwork at the same time while maintaining end-to-end life cycle changes of product labeling.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

Definition of Product Label Under EU MDR

Per the EU MDR regulations (Article 23.1, Chapter III of Annexure I), information pertaining to identification of a device, its manufacturer, relevant safety and performance information should be accompanied on the device. These aspects may appear on the device, packaging and in the IFU. Additionally, the manufacturers current website information should also be made available. In this regard, manufacturers face both design and data challenge as the organization will need to design new label templates that make room for data not previously part of the labeling system.

The name and trade name of the device
Manufacture date (if no expiration date)
Indication that the device is a medical device – All labels must include a standardized symbol to indicate that, the package being shipped into the EU contains a medical device
The details strictly necessary for a user to identify the contents of the packaging and its intended purpose
Information of the licensed EU representative, in case a medical device manufacturer is based out of the EU
The time limit for using or implanting the device safely should be expressed in terms of the year and month
Warnings or precautions that need to be brought to the immediate attention of the user while using the device
eIFU along with web address
Serial number and the lot number for an active implantable device and for other implantable devices
Instructions for use (IFUs)
Unique Device Identification (UDI) carrier
Labels must be provided in a human-readable format and may be supplemented by machine-readable information
Labels must include overall composition for devices with materials absorbed or locally dispersed in the body along with quantitative information on the main constituent(s)
Should explicitly state the requirements for sterile barrier labeling. The information shall include:
- Identification the sterile barrier
- Declaration of the sterile condition (e.g. sterile, nonsterile)
- Sterilization method
- Manufacture date (month and year)
- Expiration date (month and year)
- Directive to check IFU if package appears damaged

Individual requirements regarding the information that is to be supplied by the manufacturer are outlined in section 23.2 of the regulation.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

Challenges Faced By Manufacturers

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Label Variability: To meet the requirements, updating and validating each individual label template will be mandate if you are not using dynamic templates to support your labeling process
Update Time: Label update is a time-consuming process, wherein every single edit/update in the template will need to follow a workflow and approval process prior to being approved for production printing
Lack of Resources: The pressing demand to focus resources on EU MDR has resulted in reprioritizing and/or delaying other project initiatives, this requires manufacturers to hire, retrain or rely on outsourcing work, which adds to top line departmental costs
Uncertainty: Uncertainty about the data that needs to be submitted to EUDAMED. This type of uncertainty introduces risk, delay and potential non-compliance to label template design and the correct connection of data points from within those templates. As the EU MDR introduces more focus on risk mitigation, this is of importance

Some of the action items that your UDI must include are:

Unique identifying “part numbers” issued by a neutral party; assigned to your finished products
Product packaging must be labeled with the UDI
Some products must bear the UDI on the product itself (Direct Part Marking)
UDIs must be registered in a database (EUDAMED)

[/fusion_text][fusion_imageframe image_id=”5769|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Unique Device Identification (UDI) – Medical Labeling EU MDR – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/07/Unique-Device-Identification-UDI-Medical-Labeling-EU-MDR-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

Composition of UDI Symbol

Device Identifier (DI):
- Version or model of the device
- Labeler of the device
- Package quantity (unit of sale, multi-pack, etc.)
- Issued by your agency
Production Identifier (PI):
- Conditional, variable
- Identifies lot/batch number, serial number, software Identification, expiration date, manufacturing date (if no expiration date) if included on the device label

Location/Appearance of UDI Symbol

The UDI must appear in a plain-text version/human readable information (HRI) and in a form that uses AIDC technology
The UDI Carrier [Automated Identification for Data Capture (AIDC) and human readable interpretation (HRI) representation of the UDI] shall be on the label or on the device itself and on all higher levels of device packaging
Include only the AIDC format on the label if there are significant constraints limiting the use of both AIDC and HRI on the label
For devices intended to be used outside healthcare facilities (such as devices for home care), the HRI shall, however, appear on the label even if this results in there being no space for the AIDC
If a lot number, serial number, software identification or expiry date appears on the label, it shall be part of the UDI-PI. If there is also a manufacturing date on the label, it does not need to be included in the UDI-PI. If there is only a manufacturing date on the label, this shall be used as the UDI-PI

Celegence can provide labeling and artwork solutions with complete label integrity to meet the strictest compliance requirements for the upcoming EU MDR. Celegence team can help you evaluate if your organization is ready for EU MDR labeling requirements.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”40px” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”10px” border_radius_top_right=”10px” border_radius_bottom_right=”10px” border_radius_bottom_left=”10px” 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filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_builder_row_inner][fusion_builder_column_inner type=”1_1″ layout=”1_1″ spacing=”2%” center_content=”yes” hover_type=”none” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”10px” padding_right=”20px” padding_bottom=”0px” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” background_color=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

For more information on how we can help your regulatory labeling to comply with the EU MDR, reach out to us at info@celegence.com, contact us online or read more about Celegence’s regulatory labeling capabilities.

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Components of an Effective Post-Market Surveillance for Medical Devices

02 Jul, 2020

PMS Requirements – MDD Compared to MDR

Manufacturers are now required to update their PMS system proactively in a comprehensive and systematic fashion in accordance with EU MDR. This allows the manufacturers to set in place an interactive corrective action or preventive action process which is proportionate to the device type and update clinical evaluation documents.

It is important to note that the requirements for PMS should be directly proportional to the risk associated with the device based on its intended use.

[/fusion_text][fusion_imageframe image_id=”5756|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Requirements of Post Market Surveillance – PMS – Medical Devices” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/07/Requirements-of-Post-Market-Surveillance-PMS-Medical-Devices.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Requirements of Post Market Surveillance (PMS)[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]It is necessary to consider the product technology in relation to the manufacturer and the marketplace while developing a PMS, as there tends to be a large amount of data informing about the reasonable risks associated with the device when the device technology has been in place over a prolonged period of time. For manufacturers of new technology, there may be limited understanding of the patient population and complexities of the device state. Requirements of PMS can be met by:

State-of-the-art market experience data for similar devices may be adequate to support clinical evaluation requirements for low risk devices with a long history of use
Quantified clinical data pertaining to safety and performance of the device from peer-reviewed literature in order to support the clinical evaluation requirements
Increased monitoring ensuring early detection of risks which were not foreseen in the development phase
Post-market clinical follow-up (PMCF) may also be warranted to capture adequate real-world clinical use of the device

The analysis and review of PMS data is to be performed regularly by manufacturers as part of the risk management process. Information for risk management can be gathered from patients, physicians, healthcare facilities, regulatory authorities, professional societies, researchers and internal personnel.

[/fusion_text][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]A combination of ‘proactive’ and ‘reactive’ PMS activities form the basis of the device’s PMS plan, which is provided as a part of the assessment for CE mark certification. Proactive PMS anticipates and curtails events before they occur, gaining real-time performance data of the device. Examples include, customer surveys, post CE mark clinical trials (including PMCF), expert user groups, and manufacturer sponsored device tracking/implant registries. Reactive PMS is a passive form of data collection activities when manufacturers respond after an event has occurred. It could range from complaints to serious injury. Examples include, customer complaints, service reports, failure analysis, literature review, and non-manufacturer sponsored trials or regional/national device registries.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Quality Management System[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Based on the classification of a device, a quality management system (QMS) should cover all procedures and processes relating to aspects of design, manufacturing, supply management, risk management, complaint handling, clinical data, storage, distribution, and product labeling.

Manufacturers of all medical devices must document and prove to the notified bodies that they meet the requirements of Article 10 (General obligations of manufacturers) and Annex IX (Conformity assessment based on QMS and technical documentation) of the new EU Medical Device Regulations (EU MDR). Additional ways to meet QMS requirements include compliance with the requirements enlisted in Annexes X (Conformity assessment based on type examination) and XI (Conformity assessment based on product conformity verification).[/fusion_text][fusion_imageframe image_id=”5757|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Quality Management System for Medical Devices – Effective Post Market Surveillance (PMS)” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/07/Quality-Management-System-for-Medical-Devices-Effective-Post-Market-Surveillance-PMS.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Pre-Production QMS[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]It is considered best practice to setup a pre-production QMS, 18-24 months prior to commercialization and distribution of the device. This helps manufacturers continuously update and improve the system while they proceed internal validation procedures and market launch. In order to ensure ongoing compliance with quality system procedures, manufacturers must be encouraged to perform internal audits evaluating QMS at least once a year.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Vigilance System in PMS[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]ISO 13485 applies to all medical devices on the market and therefore PMS plans must be formulated in context to a proactive PMS.
Vigilance is an output of the quality management system and is therefore beneficial to plan post-market clinical data gathering activities during the technical documentation of a device.

Therefore, establishing a vigilance system in the post-production phase to report authorities of serious device-related incidents (reactive in nature) could effectively facilitate the detection of previously unknown adverse product information. This assessment can prove useful to prevent future recurrence of incidents that might have otherwise led to death or serious deterioration in health.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Vigilance Guidance Document[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]The Medical Device Vigilance System (MDVS) is intended to facilitate a direct, timely, and harmonized implementation of Field Safety Corrective Actions (FSCA) and FSN (Field Safety Notice) across the Member States where the device is in use.

The latest update in MDVS guidelines introduces manufacturer incident report (MIR) which details adverse event terminology/coding harmonized via the International Medical Device Regulators Forum (IMDRF) and the use of unique device identification (UDI), while introducing a single registration number (SRN), keeping in focus the future Eudamed.

Notified bodies provide support by assessment of vigilance procedures, performing audit procedures, and assessing the impact of vigilance issues on certification. Additionally, user input and feedback is vital for vigilance. Users report suspecting incidents with user interaction and cooperation is necessary for the implementation of FSCA.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Translating Clinical Data Beyond PMS Activities[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Clinical data can help in identifying residual risks of devices. Additionally, gathering robust long-term clinical data can present itself as a successful marketing tool improving economic value of the device and ultimately support product liability claims, if required. The current emphasis on PMCF requirements by EU MDR in obtaining continued clinical data stands to benefit both patients and manufacturers. A PMCF study or plan is expected to be a part of the PMS plan and in the clinical evaluation. Adequate rationale is to be provided as to why a PMCF is not applicable for a medical device.[/fusion_text][fusion_imageframe image_id=”5759|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Effective Post-Market Surveillance – Medical Devices Conclusions – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/07/Effective-Post-Market-Surveillance-Medical-Devices-Conclusions-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

Effective Post-Market Surveillance for Medical Devices – Conclusions

For more information on how we can help you create a PMS or a PMCF Plan to comply with the European Union (EU), reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device capabilities.

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Remote Medical Audits During COVID-19

02 Jun, 2020

This blog identifies how to use remote medical audits effectively and aims to help manufacturers turn massive challenges into meaningful change during these trying times. Against this backdrop, remote inspections are a new concept for most of us, and manufacturers are unsure of its objectivity, trustworthiness, credibility and effectiveness. However, we presume it to be an effective way to keep your certification program moving along, as was originally planned before the Coronavirus/ COVID-19 pandemic.

To learn more about the EU MDR changes you can view some of the previous posts in the series:

What is a remote audit? When are remote audits allowed? How does a notified body decide whether a remote audit is permitted or not? What documents are reviewed at a remote audit? How do manufacturers prepare for a remote audit? What tools should be used? When is an on-site follow-up audit required? This blog anticipates to address all these queries, to help you prepare. It is always worthwhile to check with your notified body on their modus operandi.

[/fusion_text][fusion_imageframe image_id=”5651|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”What is a Remote Medical Audit – Celegence Medical Device Consultants” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/06/What-is-a-Remote-Medical-Audit-Celegence-Medical-Device-Consultants.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]

What Is A Remote Medical Audit?

Firstly, what is a remote audit? A remote audit is the same as an on-site audit, but the auditor engages with you via technology. It is important to keep in mind that the remote audit is not to be viewed as an inferior method for performing on-site audits. Even more so than in the case of an on-site audit, it still covers documentation and record review, tours of your premises, interviews with workers and presentation of findings by using a range of technology platforms including:

Live web streaming technology such as Webex, Skype, MS Teams, GotoWebinar
Live streaming paired with mobile technology such as a smartphone or tablet with video capabilities (e.g. WhatsApp, Skype or Facetime)
Live streaming paired with technology and video headsets

If remote audits can be undertaken, it limits certification constraints as the audit program is enabled per the initial audit schedule. Remote inspections may even be cost-effective, as there are no additional expenses, such as travelling, accommodation expenses to be added. Although, be mindful, that it may be expensive in the long run if a follow-up audit is required, but this may be necessary to maintain current certification.

Most surveillance audits
Portions of recertification audits
NB Transfer Audits
Review of Covid-19–related devices

The following may not be suitable for remote audits; initial Stage II audits (unless it’s COVID-19–related), scope expansions, adding new sites, new processes and unannounced inspections etc.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Preparing for Remote Medical Audits[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Typically, your notified body will work with you on a risk-based approach. Whereby, usually a pre-audit questionnaire will be issued to the manufacturer, this will be completed and then sent back to the notified body. The Scheme Manager will review the completed documentation while taking into consideration the audit history, being mindful of the significant changes that were intended to be considered at the next audit.

Some substantial questions that needs to be addressed include;

Will the Quality Management System (QMS) be fully functional?
Will the client operate some kind of smartphone/camera application (WhatsApp, Facetime, Skype), allowing live audio/visual access to the manufacturing areas?

After assessing all of the above pointers, the Scheme Manager should contact the manufacturer and discuss the recommendation. If agreed upon by the manufacturer, the remote audit may progress.

Notified bodies may offer different approaches based on the factors above;

Full remote audit
Full remote audit with an on-site follow-up verification
Partial remote audit plus an on-site follow-up
Rescheduled on-site audit
Certification suspension

You need to check with your NB to see which of these approaches they do offer.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Remote Audit Plan[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]As with any audit, you will receive your audit plan from the assigned reviewer. They will most probably provide you with a list of documents as part of this plan, that may encompass the quality manual, an index of all QMS procedures, complaint records, corrective and preventive actions (CAPA’s) etc. The notified body should work with you on this, taking into consideration specific requirements and your technology infrastructure, to ensure a successful audit.

Post confirmation, the date will be scheduled, the audit team leader will start the audit planning process. This includes identifying and settling on the technology approach to be used during the audit.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Tools Needed for Remote Medical Audits[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

Typically, manufacturers should have a video conferencing tool; this would be something like Cisco Webex, Microsoft Teams, Skype. Whichever you choose, just ensure that the security settings are adequate to meet your needs. A successful remote audit relies on proper connectivity (i.e. voice and video) to ensure stable communication between the auditor and the auditee.

Once your connection is up and running, audit evidence will be collected via interview, review of documentation and records (via screen sharing) and observation of processes and activities (via video-sharing, if possible). It is recommended that you have a collaboration area, such as a google drive, one drive, dropbox whereby you can share documents with the auditor as required. Evidence collected will be documented, reviewed and reported to support the audit findings and conclusions – the only difference is it will be done using remote techniques. It is recommended that you have adequately tried these methods, before the audit date, ensuring that connectivity, logging on, etc., all work as anticipated.

Follow-up Audits

A follow-up audit is scheduled for recertification which mandates follow-up verification activities. It may be for a scope expansion,e.g., the addition of new sites, a new process or new devices (excluding COVID-19–specific devices).

Audit Reporting

In addition to a standard on-site audit report, remote audit reports will also include details about the remote auditing methods applied. There should not be any significant differences in the way that you receive your audit report.

[/fusion_text][fusion_imageframe image_id=”5652|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”What is a Remote Medical Audit – Celegence Medical Device Consultants” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/06/Remote-Medical-Audits-in-the-Future-Celegence-Medical-Devices-Consultants.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”4″ font_size=”” animated_font_size=”” fusion_font_family_title_font=”” fusion_font_subset_title_font=”” fusion_font_variant_title_font=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” margin_top_small=”” margin_bottom_small=””]Remote Medical Audit Conclusions[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

While we navigate the uncertainty imposed by the pandemic with new ways of living, inclusive of aspects like working from home, social distancing, and severe travel restrictions being imposed, we have to adapt the best we can. But speed is of the essence while organizations globally are experiencing workforce disruption at an unprecedented scale and speed. We are optimistic that with the key insights provided in this blog setting up, hosting and being part of a remote audit is one thing less that you and your business have to worry about. Remote audits may become a permanent fixture of our future, but for now, they are here, and we have to embrace them and work closely with our notified body to try to keep disruption to a minimum.

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animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

For more information on how we can help you with remote audits reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device capabilities.

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Addressing the Regulatory Challenges with Software as a Medical Device in EU MDR

14 May, 2020

Guidance on Qualification and Classification of Software as a Medical Device in Regulation (EU) 2017/745

“any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of, or converting that energy.”

The term Software as a medical device is defined by the MDCG as a set of instructions that processes input data (data provided through the use of a human data-input device) and creates output data (data produced by software) and are therefore deemed to be an active device as per the MDR guidelines. Medical device software is intended to drive/influence the use of a (hardware) medical device, used alone, or in combination, for a purpose as specified in the guidance document.

Your organization may benefit from the EU MDR consulting services offered by Celegence for a seamless transition to the new requirements with effective business outcomes.[/fusion_text][fusion_imageframe image_id=”5610|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Medical Device Software – Qualifying Parameters for MDSW under EU MDR – Celegence Consultants” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]https://www.celegence.com/wp-content/uploads/2020/05/Medical-Device-Software-Qualifying-Parameters-for-MDSW-under-EU-MDR-Celegence-Consultants.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” margin_top_small=”” margin_bottom_small=””]Qualifying Software as a Medical Device[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]The guideline lays out qualification criteria to clarify what type of software may subject to the regulations. The guideline states that the “Software must have a medical purpose on its own to be qualified as an MDSW.”

Firstly, the manufacturer’s product must fulfill the definition of a “medical device”, “software”, or in vitro diagnostic medical device according to Article 2(1) of Regulation (EU) 2017/745 – MDR and/or Article 2(2) of Regulation (EU) 2017/746 – IVDR. The intended purpose of the software described by the manufacturer is relevant to qualifying the software as a device and further addressing its classification.

Implementation rules 3.3 and 3.5 described in the Regulation (EU) 2017/745 – MDR or Regulation (EU) 2017/746 – IVDR also respectively apply when the software is intended as an accessory to a medical device and does not meet the definition of a medical device or an in vitro diagnostic medical device.

The qualifying factors of software as a medical device is independent of the risk of harm to users (both patients and professionals) within a healthcare setup.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” margin_top_small=”” margin_bottom_small=””]

Qualifying Parameters for Medical Device Software (MDSW)

Software that directly controls a medical device (hardware), providing immediate decision-triggering information intended to be used by healthcare professionals or patients (e.g. blood glucose meter software).
Software that provides support for healthcare professionals (e.g. ECG interpretation software).
Software intended to process, analyze, create, or modify medical information when the software is governed by a medical intended purpose (e.g. searching image for findings that support a clinical hypothesis as to the diagnosis or evolution of therapy)
Independent software, by having its intended medical purpose

Software may be qualified as MDSW regardless of its location (e.g. operating in the cloud, on a computer, on a mobile phone, or as an additional functionality on a hardware medical device). With the transformational impact of technology shaping the medical device sector, Celegence’s expert team can provide regulatory guidance and supplement information on whether your device qualifies as a MDSW.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” margin_top_small=”” margin_bottom_small=””]

Decision Tree To Assist the Qualification of Software as MDSW

[/fusion_title][fusion_imageframe image_id=”5614|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Qualification of Software as MDSW Criteria – EU MDR” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]https://www.celegence.com/wp-content/uploads/2020/05/Qualification-of-Software-as-MDSW-Criteria-EU-MDR.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” margin_top_small=”” margin_bottom_small=””]Rules for Classifying MDSW and Their Implementation[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]With regards to software medical devices, changes to classification have been a leading cause for concern. In classifying software as a medical device, Rules 9, 10, 11, 12, 13, 15, and 22 of Annex VIII EU-MDR 2017/745 are to be applied. Nearly all software medical devices are likely to be class IIa, or even class III (the highest risk category), where previously the majority have been class I. This potential up-classification can be attributed to the wide-phrasing of Rule 11 which was newly added to Annex VIII of the EU MDR.

This rule was issued with guidance from the International Medical Device Regulators Forum (IMDRF). The drafting of Rule 11 assigns a significant proportion of software medical devices to the higher classes and manufacturers have taken a cautionary approach to this rule. The implication of such strict wording has led to increase in class contingent irrespective of the probable innocuous function of the device itself. For e.g., in cases were the software performs a relatively simple function, but if the resulting decision of the device itself could impact the well-being of the patient, the device is awarded the highest risk category. This may place additional strain on the manufacturer to place the device on market.

The Medical Device Coordination Group (MDCG) Guidance on Qualification and Classification of Software, appears to soften the impact of Rule 11, providing greater clarity with regards to classification of software medical devices. It particularly describes and categorizes the significance of the information provided by an active device to the patient management in combination with patient condition by dividing them into three sub-rules.

For further details on classification rules, please refer to:
Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” margin_top_small=”” margin_bottom_small=””]Protecting Medical Device Software[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Rapidly improving technology has made Software medical devices increasingly prevalent in the healthcare sector. Securing data being stored or processed by MDSW’s has become a valid concern for manufacturers not only in the development phase but also during the product maintenance.

Susceptibility to malware is a scaling concern as the software component in several MSDW’s becomes more complex. Manufacturers must be prepared to assess security risks, detect compromise, and recover from any data breach incidents.

Designing patent protection and copyright registrations are some of the primary measures that can be taken to protect MDSW’s. Additionally, cybersecurity measures based on cryptography, digital signatures, and frequent integrity checks, may help protect system programs and data against unauthorized manipulation.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” margin_top_small=”” margin_bottom_small=””]Conclusions Regarding Software as a Medical Device and EU MDR[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

In conclusion, increased use of software as medical devices has undeniably improved several aspects of patient care and management. However, security breach of MSDW’s has presented itself as a justifiable risk and this may present as a challenge to the manufacturer and regulatory agencies to ensure adherence to conformity assessments.

The qualification criteria and classification rules detailed in the EU regulation – 2017/745 – MDR and 2017/746 – IVDR addresses gaps between standalone and incorporated software devices. The requirements help manufacturers and agencies navigate through a well laid out system while the stringent guidelines also drive manufacturers to adopt continued data protection measures.

Ensuring precise classification, adequate clinical evidence, and appropriate risk mitigation procedures play key roles in addressing and improving patient safety and device performance to successfully place a device on the market.

[/fusion_text][fusion_imageframe image_id=”5611|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Regulatory Compliance MDSW EU MDR – Medical Device – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]https://www.celegence.com/wp-content/uploads/2020/05/Regulatory-Compliance-MDSW-EU-MDR-Medical-Device-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”4″ font_size=”” animated_font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” margin_top_small=”” margin_bottom_small=””]

Key Takeaways For Software as a Medical Device Manufacturers

Software must adhere to the definition of a medical device under the MDR
To classify a software, key questions pertaining to the devices intended use and purpose must be answered
Implementation rules of Annex VIII help address the applicability of software:
- Implementation Rule 3.3, states that ‘Software, which drives or influences the use of a device, shall fall within the same class as the device’ and ‘If software is independent of any other device, it shall be classified in its own right’
- Implementing rule 3.5 states ‘If several rules, or if, within the same rule, several sub-rules, apply to the same device based on the device’s intended purpose, the strictest rule and sub-rule resulting in higher classification will apply’
Up-classification of MSDW’s will require approval from notified body prior to marketing in the EU

While you integrate modern product development methodology to compete with fast-paced innovation, partner with Celegence to ensure regulatory compliance of your MDSW to successfully place the device on the market.

For more information on how we can help you with compliance for MDSW reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device capabilities.

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Implications of COVID-19 on the Medical Device and Diagnostics Industry

22 Apr, 2020

[fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”0″ margin_bottom=”” padding_top=”0px” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”yes” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”0″ padding_right=”” padding_bottom=”” padding_left=”” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_imageframe image_id=”5554|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Implications of COVID-19 on the Medical Device and Diagnostics Industry” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]https://www.celegence.com/wp-content/uploads/2020/04/Implications-of-COVID-19-on-the-Medical-Device-and-Diagnostics-Industry.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”30px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”1″ font_size=”” animated_font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” margin_top_small=”” margin_bottom_small=””]COVID-19 Impact on the Medical Device and Diagnostics Industry[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]The SARS-CoV-2 pandemic and the unprecedented nature of this health crisis poses significant strain to the global life sciences industry. Amid uncertainty, both governing and regulatory bodies are working nonstop to ensure guidelines are set in place to aid the medical device industry in reacting to this crisis.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”15px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” margin_top_small=”” margin_bottom_small=””]Deferral of EU MDR Enforcement Due To COVID-19[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]In order to prioritize the health sector’s fight against COVID-19, and as detailed in our MDR Timelines update, the European Commission released a proposal on April 3rd, 2020 that it would defer the enforcement of the EU Medical Devices Regulation (MDR) for a year effective from May 26th, 2020. As for the In Vitro Diagnostic Regulation (IVDR), which will be applicable from May 26th, 2022, the Commission stated that the respective stakeholders will have to implement the new IVDR within the fixed transition timelines.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” margin_top_small=”” margin_bottom_small=””]

European Commission Statement Re EU MDR and Coronavirus

The official statement released by the Commission stated:

“As the coronavirus crisis increases demands for certain vital medical devices, it is crucial to avoid any further difficulties or risks of potential shortages or delays in the availability of such devices caused by capacity limitations of authorities or conformity assessment bodies related to the implementation of the Medical Devices Regulation.”

The Commission further stated that with a view to avoid disruption of the device market at such a critical time, the year-long delay will not alter the substance of MDR. Moreover, the delay will “not impose new obligations on the concerned parties. It primarily aims at providing, for exceptional reasons in the context of the current COVID-19 outbreak, a one-year deferral as regards the date of application of certain provisions of that Regulation.”

[/fusion_text][fusion_imageframe image_id=”5555|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Recommendation EU 202 403 – Celegence – COVID-19″ link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]https://www.celegence.com/wp-content/uploads/2020/04/Recommendation-EU-202-403-Celegence-COVID-19.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” margin_top_small=”” margin_bottom_small=””]Recommendation (EU) 2020/403[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]The European Commission published Recommendation (EU) 2020/403 on conformity assessment and market surveillance procedures to ensure that the industry can quickly respond to the increased demand of medical devices generated by the public health crisis, which addressed the shortage of Personal Protective Equipment (PPE) necessary in the context of the COVID-19 outbreak.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” margin_top_small=”” margin_bottom_small=””]What Does Recommendation (EU) 2020/403 Suggest?[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]In context of the current COVID-19 outbreak, the guidance document enables supply chains by allowing more devices, including Personal Protective Equipment (PPE) to be placed on the market quickly. It addresses the way in which economic operators have redesigned manufacturing lines and/or diversified supplier base in order to keep up with the increasing demands thereby reducing the risks of first responders and medical professionals.

The document suggests:

The directives address the COVID-19 outbreak as a public health crisis. Therefore, on a duly justified request Member States may authorize placing individual devices on the market within the territory of the Member State concerned, for which the conformity assessment procedures haven´t been carried out yet.
The Commission has agreed with the European Standardization Organizations that several standards are made fully available by the national standardisation bodies allowing manufacturers to download these without cost from the online catalogues of the national standardization bodies.
Additionally, the recommendations by the Commission is accompanied by a guidance document on conformity assessment procedures for PPE (such as surgical masks, exploration gloves and gowns).
The recommendation discusses the off label use of a medical device and states that when necessary to use an existing medical device for a purpose or in a way different from that intended by the manufacturer, risks and benefits to the patient are to be carefully assessed.
The following factors may be included in the assessment of the off-label use of the devices:
- Documented risk assessment in device use
- Suitable precautions to minimize risks
- Reviewing risk assessment at suitable periods
- Consideration of ethical and legal implications
- Obtaining necessary approval from competent authorities when required
Derogations allow national authorities to place certain devices on the market even if the conformity assessment procedures have not been carried out yet.
In cases of assessing the need for a derogation, the national competent authority in a Member State may consider factors such as:
- The degree of criticality of the use of the device for the protection of health
- Availability of suitable substitutes
- Documentation of compliance with a harmonized standard or other specific technical solutions ensuring fulfilment of the applicable essential requirements laid down in the relevant Directive
- Review of reports of tests performed by competent bodies
- Indications from vigilance and/or market surveillance
The recommendation mentioned that the derogation should be temporary and the period of validity limited to what is strictly required for rendering the device compliant with the legislation or, if earlier, when suitable substitutes can be expected or the critical needs will no longer be present.
The guideline also stated that clinical investigations that may have started prior to May 26, 2021 in accordance with the MDDs can be continued. However, serious adverse events need to be reported in accordance with MDR.
The Council has also rejected the proposal of the EC to change the date of obligation to place UDI (unique device identification) carriers on the label and packaging of devices.

Facilities can approach authorities for remote surveillance and recertification procedures. Manufacturers with good conformity will be approved for remote audits. Facilities that may require an on-site visit to verify the implementation of corrective actions or have a high number of nonconformities may not substitute their surveillance or recertification audit with a remote audit.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” margin_top_small=”” margin_bottom_small=””]

Remote Audit Requirements for Facilities

Facilities requesting for remote audits must adhere to requirements such as:

Communication technologies and tools to be available while adhering to data privacy and security norms
Required documentation such as audit plans, audit report, Nonconformity Grading and Exchange (NGE) form, etc. to be prepared
Notified bodies to clearly document that “the audit was performed remotely” and record any aspect of the remote audit that may have not yielded confidence which an on-site audit would have
The remote surveillance will primarily focus on activities that can be verified remotely, and elements that cannot be verified will be listed in the audit report as deviations to the plan and added to the next on-site audit

Successful remote audits will be issued with validity for 6 months and will be followed by an on-site audit within six months. A successful verification of the recertification process may lead to a certificate with a maximum validity period of 3 years calculated from the expiry date of the prior certificate. In cases where the verification process was unsuccessful, the certification shall be suspended.

[/fusion_text][fusion_imageframe image_id=”5556|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Additional Guidance Contained in the IAF – COVID-19″ link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]https://www.celegence.com/wp-content/uploads/2020/04/Additional-Guidance-Contained-in-the-IAF-COVID-19.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” margin_top_small=”” margin_bottom_small=””]Additional Guidance Contained in the IAF[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]The guidance also suggests that notified bodies may consider additional guidance contained in the IAF (International Accreditation Forum) documents while accounting for existing recent audit results with exception of any guidance which contradicts this transmittal.

The guidance ultimately states the notified bodies should consider extraordinary measures on a case-by-case basis to ensure the continual supply of medical devices during the pandemic restrictions.

Considering co-decision to be a normal lengthy procedure to reach conciliation, there may be a possibility for EU to indicate enforcement discretion to ensure devices reach patients after May 26, 2020.

Collectively, the notified bodies, manufacturers, and regulatory agencies continue to co-ordinate to maximize efficiency, while implementing the requirements of the MDR amidst the distress as the world navigates through the evolving pandemic.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”40px” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”10px” border_radius_top_right=”10px” border_radius_bottom_right=”10px” border_radius_bottom_left=”10px” box_shadow=”yes” box_shadow_vertical=”5%” box_shadow_horizontal=”5%” box_shadow_blur=”28″ box_shadow_spread=”2″ box_shadow_color=”#f1f6f8″ box_shadow_style=”” padding_top=”” padding_right=”0px” padding_bottom=”” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”#f6f8f8″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_builder_row_inner][fusion_builder_column_inner type=”1_1″ layout=”1_1″ spacing=”2%” center_content=”yes” hover_type=”none” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”10px” padding_right=”20px” padding_bottom=”0px” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” background_color=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

[fusion_fontawesome icon=”fa-info-circle fas” size=”35px” flip=”” rotate=”” spin=”no” alignment=”left” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” margin_top=”” margin_right=”10px” margin_bottom=”” margin_left=”” circle=”no” iconcolor=”#2da9e0″ circlecolor=”” circlebordercolor=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””][/fusion_fontawesome]Celegence can provide you with subject-matter experts, including both regulatory professionals and medical doctors with the relevant device expertise to help you through the MDR process during the COVID-19 pandemic. Our team of MDR experts would love to partner with you in delivering regulatory compliance end-to-end. For more information, reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device capabilities

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IMDRF & Summary of Recent Changes to Clinical Evaluation Guidance

16 Apr, 2020

This article aims to help manufacturers understand how the International Medical Device Regulators Forum (IMDRF) can assist you in designing compliant regulatory strategies, and how to access the extensive catalogue of guidance documents. The following is the eighth blog in the series related to the recent and impending updates to EU MDR 2017/745. In this blog, we will provide useful insights on some key topics and latest updates from the IMDRF.

To learn more about the EU MDR changes you can view some of the previous posts in the series:

The International Medical Device Regulators Forum or IMDRF is a voluntary group of medical device regulators from around the world who came together to build on the influential foundational work created by the Global Harmonisation Task Force on Medical Devices (GHTF), with an aim to accelerate international medical device regulatory harmonisation and convergence.

The group was founded in October 2011 by representatives from Australia, Brazil, Canada, China, EU, Japan, and the US as well as World Health Organisation (WHO) representatives. The purpose of this group is to provide a forum for members to deliberate and provide state of the art (SOTA) guidance on strategies, policies, and direction. The group works with other stakeholders such as industry Subject Matter Experts (SMEs), academia, healthcare professionals, and consumer and patient groups. The IMDRF sets up working groups that are responsible for collaborating on a variety of topics and developing technical documentation for the industry. A list of the current/closed work items is available here.

[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” margin_top_small=”” margin_bottom_small=””]Differences Between IMDRF and GHTF[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]GHTF was also a voluntary group of representatives of global regulatory authorities from the US, EU, Canada, Japan and Australia that were divided into three regions, Europe, Asia-Pacific and North America. It was disbanded in late 2012, and the IMDRF appropriated the work undertaken by GHTF. Although they share the same goal of harmonising the regulatory landscape across the world, the difference lies in the constitution of the working groups − GHTF was primarily made up of regulators and industry, while IMDRF involves many other key stakeholders, and works much more collaboratively than GHTF. Among others, the five key study groups of IMDRF focus on: Regulatory Systems, Vigilance, Quality Systems, Auditing Practices, and Clinical Practices.[/fusion_text][fusion_imageframe image_id=”5537|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Who Are the IMDRF – Celegence – Medical Device Regulators” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]https://www.celegence.com/wp-content/uploads/2020/04/Who-Are-the-IMDRF-Celegence-Medical-Device-Regulators.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” margin_top_small=”” margin_bottom_small=””]IMDRF – Recent Decisions and Work Items[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]The IMDRF publishes documents that are open to members of the public to review and provide comments on the text. A date for the completion of the consultation period is printed on the consultation document, along with an email address to share comments addressed to the group. Should you want to add comments to any of the consultation documents issued, you will need to complete the comments template, that you can find on the IMDRF website. Some of the recent consultation documents published by IMDRF are ‘Competence and Training Requirements for Regulatory Assessors’, ‘Principles of IVD classification’ and ‘Regulatory Authority Assessment Method for Recognition and Surveillance of MD Conformity Assessment Bodies’. The documents are easy to follow and assist in interpreting the regulatory requirements with ease.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” margin_top_small=”” margin_bottom_small=””]Clinical Evaluation Working Group of IMDRF – Final Guidance[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]The Clinical Evaluation Working Group of IMDRF issued a final guidance relating to clinical investigations, clinical evaluation, and key definitions relating to clinical evidence in October 2019 (IMDRF MDCE WG/N56FINAL:2019). This document supersedes the guidance document published by GHTF (GHTF/SG5/N2R8:2007). Together with the MEDDEV 2.7/1 rev 4 guidelines, the IMDRF guidance document provides detailed and easy to follow guidance on how to fulfil the requirements stipulated in MDR 2017/745.
Some key topics from the Clinical Evaluation guidance document are discussed below.[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” margin_top_small=”” margin_bottom_small=””]Key Topics from the Clinical Evaluation Guidance Document[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

Overview of Clinical Evaluation

The structure of the document walks you through the basics, covering topics such as “what is a clinical evaluation”, “why is a clinical evaluation important”, and “what is the clinical evaluation process”. It has detailed flow charts outlining “the stages of a clinical evaluation”. Software as a Medical Device and In-vitro Diagnostic Devices (IVDs) are specifically addressed. The document also provides guidance on how to effectively build literature searching strategies, how to use other clinical data, such as clinical investigations. It advises how to appraise/analyse the clinical data correctly and what should be detailed in the CER report. A list of considerations for comparability of devices and a suggested format for a Literature Search Report are provided as Appendices to the Guidance Document.

Frequency of Updates to the Clinical Evaluation Report (CER)

The IMDRF document states that the CER should be updated periodically. This frequency should be laid out in the clinical evaluation plan if you look at other guidance documents, e.g. MEDDEV 2.7.1 Rev4. It is expected that the CER should be ‘actively’ updated at least annually for high risk or new devices, and every 2 to 5 years for lower risk, well-established devices. A justification for the frequency of updates will be required. For all risk classifications of devices, the CER will need to be updated whenever new information from the Post Market Surveillance (PMS) affects the evaluation or its conclusions, the data from the risk management system should link into the CER making it an iterative process feeding back to the labelling, if necessary.

Qualifications of Report Authors and Evaluators

Section 5.0 General principals provide information relating specific requirements for the expertise and experience of CER authors and evaluators, “the clinical evaluation should be conducted by a suitably qualified individual or individuals. A manufacturer must be able to justify the choice of the evaluator(s) through reference to qualifications and documented experience” typically this would include a relevant higher education degree and five years’ related professional experience, or ten years’ professional experience if a degree is not considered a prerequisite for the task. Deviations from these requirements should be documented and duly justified. All evaluators must now make a declaration of interest, that should be appended to the final clinical evaluation report.

Equivalence

The criteria (clinical, technological, biological) are unchanged, but more information on how this should be documented and factors which could affect the demonstration of equivalence are provided. In particular, requires that design differences and their impacts on clinical safety and performance be described in detail, that comparative drawings and diagrams should be provided, and that each device with which equivalence is claimed must meet all three equivalence criteria. It may be necessary to undertake further testing to support equivalence.

The Scientific Validity of Data

Section 6.1 Identifies the datasets that are the most important in contributing to the demonstration of the overall performance of the medical device and, particular performance characteristics. It outlines why they are considered to be pivotal, and how they demonstrate the performance of the medical device collectively (e.g. consistency of results, statistical significance, the clinical significance of effects) with greater emphasis on demonstrating the scientific validity of data, including statistical considerations. Manufacturers need to address factors which can affect the scientific validity of different types of datasets. Besides, clarifying and explaining critical details throughout the document for each stage of the clinical evaluation process: factors which could affect the completeness, objectivity or weight of data should be described, including literature search and retrieval methods, identify the datasets that are considered to be the most important in contributing to the demonstration of the overall performance of the medical device and, where useful, particular performance characteristics.

Access to Data for Equivalent Devices

MEDDDEV 2.7.1 rev4 also requires that the Notified Body challenge the manufacturer’s access to data on the equivalent device(s) (Appendix A12.2.3); this is considered a transition point for the Regulation, which will require a manufacturer to have a contract in place allowing access to data for competitor devices with which equivalence is claimed.

Risk-benefit Analysis

The evaluation and quantification of benefits and risks and the assessment of the overall risk-benefit profile. The value of post-market data, and factors which could affect the statistical validity of the evaluation of this data, are addressed in some detail. The guidance eludes to the fact that the overall goal of the analysis stage is to make a benefit/risk determination if the appraised data sets available for a medical device collectively demonstrate the safety, clinical performance and effectiveness of the device in relation to its intended use.

Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF)

Throughout this guidance, it repeatedly states the links between clinical evaluations, PMS is reinforced. To ensure that post-market activities, manufacturers are expected to implement and maintain surveillance programs that routinely monitor the safety, clinical performance and effectiveness of the medical device as part of their Quality Management System. For more info see the PMCF Requirements for EU MDR.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_imageframe image_id=”5538|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”IMDRF Changes EU MDR – Celegence – Medical Device Regulators” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]https://www.celegence.com/wp-content/uploads/2020/04/IMDRF-Changes-EU-MDR-Celegence-Medical-Device-Regulators.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”4″ font_size=”” animated_font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” margin_top_small=”” margin_bottom_small=””]Changes to IMDRF Clinical Evaluation Guidance – Conclusion[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]The IMDRF website provides a repository of technical information to help manufacturers build effective regulatory strategies. The resources have been compiled by regulators and industry experts and serve to provide useful pragmatic guidance documents that help to interpret the regulations/directives. These documents should be used in combination with other guidance documents, e.g. MEDDEVs. They are designed to complement one another. When developing regulatory strategies, manufacturers should always consult the IMDRF website and check for the latest updates.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”40px” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”1_1″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”10px” border_radius_top_right=”10px” 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filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_builder_row_inner][fusion_builder_column_inner type=”1_1″ layout=”1_1″ spacing=”2%” center_content=”yes” hover_type=”none” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” border_color=”#eff2f2″ border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”10px” padding_right=”20px” padding_bottom=”0px” padding_left=”20px” margin_top=”0px” margin_bottom=”0px” background_type=”single” background_color=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” align_content=”center” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]

[fusion_fontawesome icon=”fa-info-circle fas” size=”35px” flip=”” rotate=”” spin=”no” alignment=”left” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” margin_top=”” margin_right=”10px” margin_bottom=”” margin_left=”” circle=”no” iconcolor=”#2da9e0″ circlecolor=”” circlebordercolor=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””][/fusion_fontawesome]Celegence can provide you with subject-matter experts, including both regulatory professionals and medical doctors with the relevant device expertise to complete this type of work for you or supplement your internal teams as needed. Our team of MDR experts would love to partner with you in delivering regulatory compliance end-to-end. For more information, reach out to us at info@celegence.com, contact us online or read more about Celegence’s medical device capabilities

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Regulatory Challenges in Writing EU MDR Compliant Clinical Evaluation Reports (CERs)

01 Apr, 2020

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Regulatory Challenges in Writing EU MDR Compliant Clinical Evaluation Reports (CERs)

This post will focus on the EU MDR and Clinical Evaluation Reports (CER). Read our other posts about understanding:

[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ 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border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”15px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”2″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Overview of EU MDR and Clinical Evaluation Reports (CER)[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]Production and distribution of medical devices in Europe is strictly governed by EU MDR regulations. It aims to ensure high standards of quality and safety for medical devices, replacing the previous Medical Device Directive (MDD) and the Directive on Active Implantable Medical Devices.

Key aspects of the EU MDR include:

Stricter Clinical Evaluation Requirements: Devices must undergo rigorous clinical evaluations to ensure safety and performance.
Enhanced Traceability: The regulation mandates a unique device identification (UDI) system to improve traceability.
Post-Market Surveillance: Manufacturers are required to continuously monitor the performance and safety of their devices once they are on the market.
Transparency and Documentation: Increased transparency through the European database on medical devices (Eudamed) and detailed technical documentation requirements.

These regulations are crucial for maintaining patient safety and fostering innovation in the medical device industry. A Clinical Evaluation Report (CER) is one of the crucial documents required under the EU MDR. It involves the assessment and analysis of clinical data related to a medical device to verify its clinical safety and performance. The CER must be continuously updated with new clinical data as it becomes available, ensuring ongoing compliance with the EU MDR.[/fusion_text][fusion_imageframe image_id=”20868|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Regulatory Challenges Medical Device Manufacturers” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” max_width=”” sticky_max_width=”” align_medium=”none” align_small=”none” align=”none” mask=”” custom_mask=”” mask_size=”” mask_custom_size=”” mask_position=”” mask_custom_position=”” mask_repeat=”” style_type=”” blur=”” stylecolor=”” hue=”” saturation=”” lightness=”” alpha=”” hover_type=”none” magnify_full_img=”” magnify_duration=”120″ scroll_height=”100″ scroll_speed=”1″ margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” bordersize=”” bordercolor=”” borderradius=”” z_index=”” caption_style=”off” caption_align_medium=”none” caption_align_small=”none” caption_align=”none” caption_title=”” caption_text=”” caption_title_tag=”2″ fusion_font_family_caption_title_font=”” fusion_font_variant_caption_title_font=”” caption_title_size=”” caption_title_line_height=”” caption_title_letter_spacing=”” caption_title_transform=”” caption_title_color=”” caption_background_color=”” fusion_font_family_caption_text_font=”” fusion_font_variant_caption_text_font=”” caption_text_size=”” caption_text_line_height=”” caption_text_letter_spacing=”” caption_text_transform=”” caption_text_color=”” caption_border_color=”” caption_overlay_color=”” caption_margin_top=”” caption_margin_right=”” caption_margin_bottom=”” caption_margin_left=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/04/Regulatory-Challenges-Medical-Device-Manufacturers.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”30px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Regulatory Challenges for Medical Device Manufacturers[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” 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Medical device manufacturers face several regulatory challenges that can impact their operations and market access. They, like all businesses, expend their limited resources very carefully, making it difficult to invest equally in all products.

Evolving Regulations: Regulatory frameworks, such as the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), are continuously evolving. Keeping up with these changes requires significant resources and constant monitoring.
Clinical Evidence Requirements: Manufacturers must provide robust clinical evidence to demonstrate the medical device safety and efficacy. This often involves extensive clinical trials and data collection, which can be time-consuming and costly.
Global Compliance: Different countries have varying regulatory requirements. Navigating these diverse regulations can be complex, especially for companies operating in multiple markets. For instance, the Medical Device Single Audit Program (MDSAP) aims to streamline audits across several countries, but it still requires thorough preparation.
Cybersecurity: With the increasing integration of digital technologies in medical devices, ensuring cybersecurity has become a critical regulatory requirement. Manufacturers must protect patient data and device functionality from cyber threats.
Supply Chain Management: Ensuring that all components and materials used in medical devices comply with regulatory standards is a significant challenge. This involves rigorous supplier audits and quality control measures.
Post-Market Surveillance: Manufacturers are required to continuously monitor the performance of their devices once they are on the market as part of post-market surveillance requirements. Reporting of adverse events and implementation of corrective actions is also required under new provisions.

Addressing these challenges requires a proactive approach, including investing in regulatory expertise, adopting advanced technologies for data management, and maintaining robust quality management systems (QMS). Streamlining these processes is essential for medical device manufacturers to ensure efficiency and compliance.

EU MDR Checklist mostly includes

General Administrative Information
Applicable Legislation
General Safety and Performance Requirements (GSPRs)
Clinical Evaluation
Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF)
Summary of Safety and Clinical Performance (SSCP)

The EU Commission has also introduced additional guidance documents to help manufacturers navigate the new requirements, including templates for clinical evaluation plans and reports that align with MEDDEV 2.7.1 Rev 4. These guidelines and checklist items are essential for ensuring compliance with the EU MDR and maintaining market access in the European Union.[/fusion_text][fusion_imageframe image_id=”20867|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Notified Bodies Requirements Medical Devices – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” max_width=”” sticky_max_width=”” align_medium=”none” align_small=”none” align=”none” mask=”” custom_mask=”” mask_size=”” mask_custom_size=”” mask_position=”” mask_custom_position=”” mask_repeat=”” style_type=”” blur=”” stylecolor=”” hue=”” saturation=”” lightness=”” alpha=”” hover_type=”none” magnify_full_img=”” magnify_duration=”120″ scroll_height=”100″ scroll_speed=”1″ margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” bordersize=”” bordercolor=”” borderradius=”” z_index=”” caption_style=”off” caption_align_medium=”none” caption_align_small=”none” caption_align=”none” caption_title=”” caption_text=”” caption_title_tag=”2″ fusion_font_family_caption_title_font=”” fusion_font_variant_caption_title_font=”” caption_title_size=”” caption_title_line_height=”” caption_title_letter_spacing=”” caption_title_transform=”” caption_title_color=”” caption_background_color=”” fusion_font_family_caption_text_font=”” fusion_font_variant_caption_text_font=”” caption_text_size=”” caption_text_line_height=”” caption_text_letter_spacing=”” caption_text_transform=”” caption_text_color=”” caption_border_color=”” caption_overlay_color=”” caption_margin_top=”” caption_margin_right=”” caption_margin_bottom=”” caption_margin_left=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″]https://www.celegence.com/wp-content/uploads/2020/04/Notified-Bodies-Requirements-Medical-Devices-Celegence.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”30px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Notified Body Requirements for Medical Devices[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]Notified bodies play a crucial role in the conformity assessment of medical devices before they can be placed on the market in the EU. They are designated by an EU Member State or other countries under specific agreements. They must meet stringent requirements related to organizational aspects, quality management, resources, and processes.

They assess whether medical devices comply with the MDR or IVDR which includes examining the technical design, testing the products, reviewing compliance documentation. Auditing manufacturer quality management system and performing products checks. Due to the difference in the type and risk of devices the process of audit becomes very complex. However irrespective of differences in price sales complexity of the products they still have to go through similar stringent rules for certification. The involvement of a notified body depends on the classification of the medical device. For example, Class I devices that are sterile, have a measuring function, or are reusable surgical instruments, as well as Class IIa, IIb, and III devices, require a notified body[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Clinical Evaluation Report[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]A Clinical Evaluation Report (CER) is a comprehensive document that summarizes the clinical evaluation process for a medical device. It is essential for demonstrating the safety and performance of the device, particularly for regulatory approval in the EU under the Medical Devices Regulation EU 2017/745 (MDR).

These documents are mandatory mostly and are essential for manufacturers to obtain the CE certification. A Notified body shall audit all the CER except the class I products which are self-certified. The first important part of creating a CER is to prepare a CEP, which details the plan on how the evidence will be presented from which sources will they be obtained for the subject devices. Next step is to identify any clinical gaps in the clinical evidence for the subject device. Once done the quality appraisal and scientific validity of the clinical data is evaluated which is the third step. And the last but not least important part of CER is the evaluation of evidence that the device complies with GSPR.

Major important sections of CER are:

Scope and Plan: Define the scope of the clinical evaluation and create a detailed plan outlining the objectives, methodology, and timelines
Identification of Data: Gather relevant clinical data from various sources, including clinical investigations, scientific literature, and post-market surveillance (PMS) data.
Appraisal of Data: Assess the quality and relevance of the collected data. This involves evaluating the scientific validity and applicability of the data to the device in question.
Analysis of Data: Analyze the clinical data to determine the device’s safety and performance. This includes assessing the benefit-risk profile, identifying residual risks, and addressing any uncertainties or unanswered questions.
Compilation of the Report: Summarize the findings in a structured report. The CER should include:
- General information about the device and manufacturer
- Description of the device’s intended purpose and technical characteristics
- Summary of clinical data and its appraisal
- Analysis demonstrating conformity with relevant safety and performance requirements
Continuous Updates: The CER is a living document that should be regularly updated with new clinical data especially from post market surveillance activities.

[/fusion_text][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”3″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]Navigating Regulatory Challenges with Expert Assistance[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=”” logics=””]Navigating regulatory challenges can be complex, but expert assistance can significantly streamline the process. Celegence offers tailored consulting services to help manufacturers navigate the complex regulatory landscape. Our experts provide strategic advice and hands-on support to optimize the clinical evaluation process. With the help of our experts, you can easily navigate through complex regulations, ensure global compliance and make sure your product meets all necessary standards for international markets.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center 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alignment=”center” /][fusion_title title_type=”text” marquee_direction=”left” marquee_speed=”15000″ rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” title_link=”off” link_url=”” link_target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” content_align_medium=”” content_align_small=”” content_align=”left” size=”4″ animated_font_size=”” fusion_font_family_title_font=”” fusion_font_variant_title_font=”” font_size=”” line_height=”” letter_spacing=”” text_transform=”” text_color=”” hue=”” saturation=”” lightness=”” alpha=”” animated_text_color=”” text_shadow=”no” text_shadow_vertical=”” text_shadow_horizontal=”” text_shadow_blur=”0″ text_shadow_color=”” text_stroke=”no” text_stroke_size=”1″ text_stroke_color=”” text_overflow=”none” margin_top_medium=”” margin_right_medium=”” margin_bottom_medium=”” margin_left_medium=”” margin_top_small=”” margin_right_small=”” margin_bottom_small=”” margin_left_small=”” margin_top=”” margin_right=”” margin_bottom=”” margin_left=”” margin_top_mobile=”” margin_bottom_mobile=”” gradient_font=”no” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ highlight_color=”” style_type=”default” sep_color=”” link_color=”” link_hover_color=”” animation_type=”” animation_direction=”left” animation_color=”” animation_speed=”0.3″ animation_delay=”0″ animation_offset=””]

Clinical Evaluation Reports (CER) Specialists

Our medical writing specialists in Clinical Evaluation process can provide invaluable support to medical by ensuring compliance with regulatory requirements and streamlining the CER preparation process. Our regulatory experts have in-depth knowledge of regulatory guidelines, such as the EU Medical Device Regulation (MDR) and FDA requirements and we ensure that the CER meets all necessary standards as per market standards. By leveraging the expertise of our CER specialists, manufacturers can ensure their clinical evaluation reports are thorough, compliant, and ready for regulatory submission.

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FDA Medical Device Registrations – 510(k) Submissions

25 Mar, 2020

Based on the changes being made to the product, there are different types of 510(k) submissions that a manufacturer can choose. These are Traditional 510(k), Special 510(k) and Abbreviated 510(k) pathways, each associated with different review timelines. Manufacturers qualifying for a Special 510(k) are at an advantage owing to the 30-day submission processing in comparison to the 90-day submission processing timeline for a Traditional and Abbreviated 510(k).

Celegence can help you identify if your medical device qualifies for a Special 510(k) and you can benefit from the reduced processing time for your 510(k).[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_global id=”5197″][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ admin_toggled=”no” type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_1″ layout=”2_3″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_image_id=”” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” sep_color=”” top_margin=”15px” bottom_margin=”” border_size=”” icon=”” icon_circle=”” icon_circle_color=”” width=”” alignment=”center” /][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”2″ font_size=”” animated_font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” margin_top_small=”” margin_bottom_small=””]Different Types of 510(k) Submissions[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Based on the changes being made to the product, there are different types of 510(k) submissions that a manufacturer can choose. These are Traditional 510(k), Special 510(k) and Abbreviated 510(k) pathways, each associated with different review timelines. Manufacturers qualifying for a Special 510(k) are at an advantage owing to the 30-day submission processing in comparison to the 90-day submission processing timeline for a Traditional and Abbreviated 510(k).

Celegence can help you identify if your medical device qualifies for a Special 510(k) and you can benefit from the reduced processing time for your 510(k).[/fusion_text][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” margin_top_small=”” margin_bottom_small=””]The Special 510(k) Pathway – Medical Device Submissions[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” content_alignment_medium=”” content_alignment_small=”” content_alignment=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” sticky_display=”normal,sticky” class=”” id=”” font_size=”” fusion_font_family_text_font=”” fusion_font_variant_text_font=”” line_height=”” letter_spacing=”” text_color=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]The Special 510(k) pathway was previously limited to review of changes to a cleared device that did not impact its intended use or alter the device’s fundamental scientific technology. In a newly published FDA guidance, FDA has revamped this approach to make this pathway more inclusive by allowing for certain intended use changes and technological changes with well-established qualification methods to be reviewed under a Special 510(k).

Manufacturers can submit their device modifications as a Special 510(k) if they meet the following minimum requirements:

The proposed change is submitted by the manufacturer legally authorized to market the existing device meaning the modification must be made to manufacturer’s own device
Performance data are unnecessary, or if performance data are necessary, well-established methods are available to evaluate the change; and
All performance data necessary to support substantial equivalence (SE) can be reviewed in a summary or risk analysis format.

The FDA guidance document “The Special 510(k) Program” issued September 13, 2019 provides information and examples of types of intended use and technological changes that may be eligible for this pathway.[/fusion_text][fusion_imageframe image_id=”5468|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Not All Device Modifications Require a 510(k) Submission – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]https://www.celegence.com/wp-content/uploads/2020/03/Not-All-Device-Modifications-Require-a-510k-Submission-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”3″ font_size=”” animated_font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” margin_top_small=”” margin_bottom_small=””]

Not All Device Modifications Require a 510(k) Submission

It is important to understand that not all modifications to a device require a 510(k) submission (21 CFR 807.81 (a)(3)). A risk-based approach is necessary to determine if the change triggers a 510(k) to FDA. This determination is made in consultation with FDA guidances ‘Deciding When to Submit a 510(k) for a Change to an Existing Device’ and ‘Deciding When to Submit a 510(k) for a Software Change to an Existing Device’. After this decision is made, the eligibility for a Special 510(k) can be determined based on the performance testing (if any) that are needed to qualify the change. The specific considerations for this determination is provided as a flowchart in the guidance document.

The first consideration in determining eligibility is whether the change is being made to manufacturer’s own device. The Agency is relying on previous detailed review of the same product and the robustness of the manufacturer’s design control processes through this question.

The next consideration is whether performance data is needed to evaluate the change. Some changes may be based on scientific rationale in which case the Special 510(k) needs to be accompanied with a clear rationale explaining why performance data was not deemed necessary.

In cases where the design control process leads to need for additional verification or validation testing, the next consideration is whether a well-established method exists for evaluation of the change.

The well-established methods include:

The submitter’s methods, protocols, and acceptance criteria used to support the previously cleared 510(k) that can be applied to the subject 510(k);
Methods found in an FDA-recognized voluntary consensus standard or FDA guidance document;
Qualified medical device development tools (MDDTs); or
Widely available and accepted methods published in the public domain, scientific literature, or found acceptable by FDA through the submitter’s own 510(k)-clearance, a granted De Novo classification request, or premarket application (PMA) approval.

Note that not all devices have product specific guidance documents or applicable consensus standards. In such cases, use of same test methodology as described in a previous 510(k) or other pre-market applications is a suitable alternative.

The final consideration is whether the data generated can be reviewed in a summary or risk analysis format. Submission of complete test reports defeats the purpose of a Special 510(k) and may lead to conversion of the submission to a Traditional 510(k). The results from verification and validation need to be provided in a summary format or risk analysis format. This information should be sufficient to establish SE to the predicate device.

The specific instances where FDA believes a Special 510(k) is not appropriate is also described in the guidance document. This includes situations where FDA would need to review complete test reports in order to determine SE.

Convert A Special 510(k) to a Traditional 510(k)

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]FDA can convert the Special 510(k) to a Traditional 510(k) if SE determination cannot be made through information submitted in a Special 510(k). Such decisions have FDA management concurrence and are typically conveyed to the submitted during Refuse To Accept (RTA) review process. This type of conversion results in delays as the content of the Traditional 510(k) varies from a Special 510(k) and this data gap needs to be fixed for a complete review. Therefore, in cases where there are deviations from well-established methods and the manufacturer is unsure about use of Special 510(k) pathway, a Pre-Submission meeting with FDA can be considered to ensure success of the regulatory strategy.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” 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border_position=”all” border_radius_top_left=”” border_radius_top_right=”” border_radius_bottom_right=”” border_radius_bottom_left=”” box_shadow=”no” box_shadow_vertical=”” box_shadow_horizontal=”” box_shadow_blur=”0″ box_shadow_spread=”0″ box_shadow_color=”” box_shadow_style=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” background_type=”single” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ last=”true” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true”][fusion_imageframe image_id=”5469|full” max_width=”” style_type=”” blur=”” stylecolor=”” hover_type=”none” bordersize=”” bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”FDA Guidance Interpretation Specialists – Celegence” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]https://www.celegence.com/wp-content/uploads/2020/03/FDA-Guidance-Interpretation-Specialists-Celegence.jpg[/fusion_imageframe][fusion_title title_type=”text” rotation_effect=”bounceIn” display_time=”1200″ highlight_effect=”circle” loop_animation=”off” highlight_width=”9″ highlight_top_margin=”0″ before_text=”” rotation_text=”” highlight_text=”” after_text=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” content_align=”left” size=”4″ font_size=”” animated_font_size=”” line_height=”” letter_spacing=”” margin_top=”” margin_bottom=”” margin_top_mobile=”” margin_bottom_mobile=”” text_color=”” animated_text_color=”” highlight_color=”” style_type=”default” sep_color=”” margin_top_small=”” margin_bottom_small=””]FDA Guidance Interpretation Specialists[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]Celegence provides regulatory strategy consulting and can help you navigate the complexities of FDA guidance interpretation and FDA interactions. Reach out to us at info@celegence.com or contact us online for more information.[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” publish_date=”” class=”” id=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”40px” padding_left=”” gradient_start_color=”” gradient_end_color=”” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ 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