The regulatory environment for medical devices continues to evolve at a rapid pace. With increasingly stringent requirements under the EU MDR, specific expectations in global markets, frequent updates to regulatory standards, and the complexity of high-risk device portfolios, manufacturers are facing greater challenges than ever in aligning their compliance strategies.

Our recent webinar brought together expert insights on how manufacturers can strategically navigate the evolving regulatory landscape by strengthening their clinical evaluation processes, maintaining audit readiness, leveraging digital tools such as CAPTIS®, and embracing future-focused regulatory foresight.

The Foundation: Understanding the Impact of Regulatory Divergence

Regulatory divergence refers to the differences in medical device requirements and approval processes across countries and regions. These variations impact product development, market access, clinical testing, and launch timelines. Understanding and managing these differences is key to ensuring compliance, accelerating time-to-market, and staying competitive globally.

The Role of Clinical Evaluation in Compliance

A well-defined clinical strategy is indispensable for meeting the diverse regulatory requirements worldwide. Clinical evaluation ensures evidence is purposeful, aligned with the device’s intended use, and effectively supports safety and performance claims. Clinical evaluation plays a crucial role in maintaining ongoing compliance by:

• Supporting successful Notified Body audits
• Reinforcing alignment to evolving regulatory standards
• Mitigating risks of delays or non-conformities.

Leveraging Technology to Drive Efficiency and Accuracy

Technology integration is a strategic advantage for achieving regulatory compliance and audit readiness. Solutions such as Celegence’s CAPTIS® leverage automation, AI, and structured content management to streamline documentation and regulatory workflows.

These digital tools offer:

• Improved Data Management: Better version control and organization reduce errors and duplication of effort
• Process Automation: Automating repetitive tasks speeds up document creation and review
• AI-Driven Evidence Analysis: AI can sift through vast volumes of clinical literature, extracting relevant data accurately and efficiently—a task that is particularly valuable for high-risk devices with complex evidence requirements.

While AI accelerates processes, experienced regulatory professionals remain essential for oversight, quality assurance, and final decision-making within a human-in-the-loop model.

Audit Readiness

Audit readiness is often viewed as a challenging but essential pillar for compliance throughout the medical device lifecycle. A structured, proactive approach can ensure manufacturers are prepared for both scheduled and unannounced regulatory inspections. Key components include:

• Pre-Submission Consultation: Consulting with notified bodies and regulatory experts early helps identify documentation gaps and align with regulatory requirements, reducing submission delays or rejections
• Comprehensive Documentation: Maintaining organized, complete, and up-to-date technical files, clinical evaluation reports (CERs), risk management files, and post-market surveillance plans is critical. These documents must be audit-ready—formatted and accessible to facilitate efficient review
• Team Training and Awareness: Everyone involved, from regulatory affairs to quality assurance, technical and clinical teams, must be well-trained in relevant regulatory requirements and their specific roles during the audits. Familiarity with internal procedures and confident responses to auditors’ inquiries strengthen audit readiness
• Traceable Evidence: Demonstrating compliance requires clear, traceable documentation aligned with regulatory standards, including clinical data, conformity assessments, and risk-benefit analyses
• Communication and Logistics: Planning the audit schedule, ensuring key personnel availability, preparing facilities, and establishing audit response protocols all contribute towards smooth inspections
• Mock Audits: Conducting internal or third-party mock audits acts as a rehearsal, revealing gaps in documentation or processes and enabling corrective actions to be taken ahead of formal audits.

Future-Proofing Compliance: Regulatory Foresight

The regulatory landscape is dynamic, with frequent updates and evolving expectations—especially in medical devices and digital health sectors. Staying compliant requires a proactive approach which involves not just reacting to changes but anticipating them.

Manufacturers who embed regulatory foresight into their strategies can:

• Innovate confidently
• Respond swiftly to regulatory changes
• Maintain trust with Notified Bodies and end users.

Proactive monitoring of guidance documents and standards, coupled with early integration of regulatory changes, reduces compliance risks and positions manufacturers for long-term success.

Key Takeaways

• Harmonized and comprehensive EU MDR documentation can be leveraged for other regulatory submissions with minimal modifications, improving operational efficiency and reducing compliance costs
• Technology platforms, including AI tools, significantly reduce manual effort and increase accuracy in documentation and evidence analysis
• Human expertise remains essential to interpret AI-generated outputs and make informed regulatory decisions
• Audit readiness is fundamental for seamless Notified Body audits and maintaining regulatory compliance
• Clinical evaluation is the compass guiding compliance efforts and ensuring patient safety
• Regulatory foresight is a necessity in a rapidly evolving environment to sustain market presence and innovation.

Final Thought

Compliance is not a one-time occurrence but an ongoing journey. Robust clinical evaluation combined with strategic use of technology and a future-focused mindset equips manufacturers to navigate this journey with greater confidence.

As echoed in our webinar:
“Compliance is a journey, and robust clinical evaluation is your compass.”

By adopting these principles, medical device manufacturers can meet regulatory expectations, enhance operational efficiency, and most importantly, ensure patient safety.

What is Adverse Event Reporting (AER)?

The process of Adverse Event Reporting (AER) involves the systematic recording and submission of information about adverse events that occur during the use of medical products (drugs, devices and vaccines) Such reports contribute significantly to the surveillance of product safety by regulatory agencies, allowing for prompt action when needed to ensure public health and safety.

Importance of Reporting in Medical Devices

Adverse events are any unexpected, harmful or untoward medical occurrence related to the use of the medical product in humans not necessarily caused by the product. Reporting of adverse events in medical devices is a critical part of post-market surveillance aimed at ensuring the continued safety and performance of medical devices after their use. This includes the identification, documentation and reporting of incidents in which the device may have caused or contributed to injury, death or malfunction. Adverse events can be reported by manufacturers, importers, distributors, healthcare providers and patients/consumers.

Reporting Requirements and Key Information

Reporting requirements for adverse events (AEs) vary according to jurisdiction, type of organisation and severity of the event. Serious incidents causing death, serious injury or deterioration of health; requiring medical or surgical intervention or causing permanent impairment should be reported. A recurring device malfunction which has the potential to cause serious harm should be reported. The regulatory authorities usually require information related to reporter, device, date of occurrence, description of the events, outcome and severity. If the reporter is a manufacturer, details related to corrective and preventive actions, recalls, field safety corrective actions, if any are also required. when a medical device adverse event report is submitted. The objective is to present a comprehensive and unambiguous image of the event, device, and patient outcome.

Global Regulatory Frameworks and Reporting Systems

Every nation has set up a different regulatory framework with distinct reporting procedures, specifications, and deadlines for tracking and handling incidents involving medical devices. Manufacturers, medical professionals, and regulatory affairs specialists working in a global market must comprehend these distinctions.

United States – FDA

The Food and Drug Administration (FDA) is in charge of regulating medical devices in the US. The Manufacturer and User Facility Device Experience (MAUDE) database and the MedWatch application are the main reporting platforms. Adverse events must be reported by manufacturers, importers, and device user facilities in accordance with the Medical Device Reporting (MDR) regulation (21 CFR Part 803). The eMDR system must be used to electronically submit reports. The FDA mandates that events requiring immediate corrective action be reported within five workdays, and that serious injuries or deaths be reported within thirty calendar days. The FDA can respond promptly to safety communications and recalls thanks to this strong system. The TPLC and MAUDE database searches are integrated in CAPTIS® platform of Celegence. It enables the medical writers to seamlessly conduct database searches and analysis of the search results to obtain quality outcomes.

European Union – EUDAMED

The Medical Device Regulation (EU) 2017/745, which requires the reporting of serious incidents and field safety corrective actions, governs medical devices in the European Union. EUDAMED (European Database on Medical Devices) is the EU’s central database for medical device vigilance. Incidents must be reported by importers, manufacturers, and authorized representatives; patients and healthcare providers may voluntarily report through the appropriate national authorities. The deadlines are strict: death or a major decline in health must be reported within two days, major public health threats must be reported right away, and other serious incidents must be reported within ten to fifteen days.

United Kingdom – MHRA

The Medicines and Healthcare Products Regulatory Agency (MHRA) was the regulatory pathway that the United Kingdom established. Systems like the Manufacturer’s Online Reporting Environment (MORE) and the Yellow Card Scheme are still used in the UK to report adverse events. Within a certain amount of time—two days for public health threats, ten days for fatalities or serious injuries, and fifteen days for other reportable incidents—manufacturers and their UK Responsible Persons are required to report serious incidents.

Canada – Health Canada

Health Canada is in charge of medical device safety in Canada through the Medical Device Problem Report system and the Canada Vigilance Program. According to the law, distributors, importers, and manufacturers must report unfavorable incidents. Timelines for reporting incidents are set at 30 days for other incidents and 10 days for events that pose a serious risk. Reports may be submitted via specified forms or electronically.

Australia – TGA

The Incident Reporting and Investigation Scheme (IRIS) is run by the Therapeutic Goods Administration (TGA), Australia’s regulatory body. According to Australian laws, healthcare providers may choose to report adverse events voluntarily, but sponsors—including importers and manufacturers—must report them. According to severity, the reporting deadlines are tier-based: two days for major public health threats, ten days for major injuries or fatalities, and thirty days for less important incidents.

Japan – MHLW and PMDA

Medical device vigilance in Japan is a joint responsibility of the Ministry of Health, Labor, and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA). Marketing authorization holders can report more easily thanks to the J-MEDWATCH system. If an adverse event is considered serious, it must be reported within 15 days; for less serious incidents, reporting must be done on a regular basis. The highly structured regulatory environment in Japan places a strong emphasis on traceability and documentation.

China – NMPA

Adverse event reporting in China is regulated by the National Medical Products Administration (NMPA) via a national electronic monitoring system. Manufacturers, holders of marketing authorizations, and healthcare facilities are required to report. For other kinds of incidents, regular safety updates are necessary, and serious adverse events must be reported within 15 days. In recent years, China’s regulatory framework has undergone significant modernization, bringing it closer to international norms.

India – CDSCO

The Materiovigilance Programme of India (MvPI) is run by the Central Drugs Standard Control Organization (CDSCO), India’s regulatory body, to keep an eye on adverse events linked to medical devices. While hospitals and medical professionals voluntarily participate through Adverse Drug Reaction Monitoring Centers (AMCs), manufacturers and importers are obligated to report incidents. India strives to conform to international reporting standards, despite the fact that timelines are not as clearly stated as in other nations.

Global Challenges in Adverse Event Reporting

A crucial but difficult part of international health systems is the reporting of adverse events for medical devices. A number of factors, including underreporting, inconsistent regulatory frameworks, divided responsibilities, technological constraints, and cultural considerations, contribute to the complexity. A diversified strategy is needed to address these issues, including coordinating global standards, making investments in digital infrastructure, encouraging a transparent and safe culture, and utilizing advanced analytics to improve signal detection.

The Role of Technology in Adverse Event Management

The application of advanced technologies, such as Artificial Intelligence (AI) and Machine Learning, is being investigated for their potential to augment signal identification and pattern recognition within extensive AE (Adverse Event) databases. Furthermore, the fusion of AE documentation with Electronic Health Records (EHRs) can automate data acquisition, alleviate the workload of clinicians, and enhance the precision of the data.

Toward Safer and More Reliable Medical Devices

In conclusion, medical device adverse event reporting is essential to patient safety and preserving the integrity of healthcare systems. It facilitates prompt regulatory actions and ongoing product development by gathering real-world data on device performance and related risks. Its efficacy is hampered by issues like underreporting, disjointed regulatory frameworks, and poor technological integration. In order to get past these obstacles, manufacturers, medical professionals, regulators, and patients must work together. Post-market surveillance will be strengthened and everyone will eventually have access to safer and more dependable medical devices thanks to the development of digital reporting systems, the standardization of international standards, and the promotion of an open culture.

Contact us today at info@celegence.com to learn how we can help your team with global adverse event reporting and strengthen your medical device compliance strategy.

Once a product is confirmed as a combination product, the next step is identifying its Primary Mode of Action (PMOA). This is defined as the single mode of action that provides the most important therapeutic effect of the product.

If the product’s intended therapeutic benefit is primarily achieved through a chemical or metabolic interaction, then it is typically drug-led. If the effect is driven by physical means, such as mechanical support or energy transmission, it is considered device-led.

The PMOA determines which FDA center will lead the regulatory review. For example:

• Drug-led products are generally reviewed by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).
• Device-led products fall under the purview of the Center for Devices and Radiological Health (CDRH).

Understanding this distinction is crucial because it dictates the regulatory submission pathway, data requirements, and even post-approval compliance expectations.

Comparing Drug-Led and Device-Led Pathways

To illustrate the regulatory differences, the table below outlines key contrasts between the two classifications:

In cases where the PMOA is not obvious, the FDA may determine the lead center based on precedent or safety and effectiveness concerns. This is why early interaction with the FDA is strongly encouraged.

Gray Areas and Borderline Scenarios

Innovative therapies don’t always fit neatly into predefined categories. Consider, for example, a therapeutic powder that forms a gel upon hydration and controls the release of a drug physically, without any chemical reaction. While it may appear to be a simple formulation, the polymer mechanism may qualify as a device component. In such borderline cases, even the excipient could be classified as a regulated device.

Another emerging gray area involves digital health integrations. Take the example of an antipsychotic pill embedded with an ingestible sensor to track adherence. Although the drug provides the treatment, the device aspect introduces complexity in classification. FDA treated this as a drug-led combination product with additional review of the device software and hardware elements.

Sponsors dealing with similar situations should not assume a default classification. Instead, they should seek clarity from the FDA early, using the pathways discussed below.

Engaging the FDA: RFD and Pre-Submission Pathways

To avoid ambiguity and regulatory missteps, the FDA offers sponsors two main avenues for determining classification:

1. Request for Designation (RFD)
   The RFD is a formal process through which the sponsor asks the FDA’s Office of Combination Products (OCP) to determine whether the product is a combination product, and if so, which center will lead the review. The FDA is required to respond within 60 days, providing a binding decision.
2. Pre-Request for Designation (Pre-RFD)
   This is a less formal, non-binding method to engage FDA on classification questions. Sponsors can initiate Pre-RFD discussions to explore how the agency views their product, receive preliminary input, and prepare more confidently for the full RFD if needed.Engaging FDA through these channels early in development ensures that sponsors follow the correct regulatory path and gather the appropriate data from the start.

Developing a Regulatory Strategy

After classification is determined, sponsors must design a development strategy that aligns with the assigned pathway.

For drug-led products, this typically involves:

• Filing an Investigational New Drug (IND) application.
• Conducting clinical studies focused on safety and efficacy.
• Submitting a New Drug Application (NDA) or Biologics License Application (BLA).
• Demonstrating that any device component (e.g., injector, delivery system) is safe, functional, and appropriate for the intended user population.

For device-led products, development may involve:

• Submitting a Pre-Submission (Q-Sub) for FDA feedback.
• Filing an Investigational Device Exemption (IDE) if clinical studies are needed.
• Preparing a 510(k), De Novo, or Premarket Approval (PMA) submission.
• Including supporting drug data to ensure safety of the drug component, even if secondary.

Sponsors must also comply with hybrid quality systems, combining drug GMP (21 CFR Parts 210/211) and device QSR (21 CFR Part 820). The FDA has published 21 CFR Part 4 to provide guidance on integrating these systems for combination product development.

Recent Regulatory Updates (2023–2025)

In the past few years, FDA has introduced several new guidances that significantly impact combination product development:

• Combination Product User Fees (2024): Clarifies which user fees apply when submitting a single combined application for a combination product.
• Use-Related Risk Analysis (2024, Draft): Encourages risk assessments tied to user interaction—especially important for auto-injectors and at-home devices.
• Human Factors Engineering (2023): Offers a Q&A-style guide for incorporating usability studies in combination product submissions.
• Drug-Device Software (2023, Draft): Discusses regulatory expectations for mobile apps, sensors, and digital interfaces that form part of a combination product.
• Premarket Pathways for Combination Products (2022): Affirms that most combination products can follow a single submission path, and outlines principles for determining when more than one submission may be needed.

Each of these documents provides valuable insight into FDA expectations, helping sponsors avoid roadblocks and design programs that meet current regulatory standards.

Key Takeaways for Developers in 2025

Combination product development is a multidisciplinary challenge, requiring strategic foresight and active regulatory engagement. Here are four key takeaways for sponsors:

• Start with clear classification: Use 21 CFR 3.2(e) and, when in doubt, engage the FDA early via Pre-RFD or RFD.
• Build your development strategy based on PMOA: Whether your product is drug-led or device-led, understand how that affects submission type, testing, and timelines.
• Address both components: Ensure your development plan includes appropriate testing for both drug and device aspects—neither can be neglected.
• Stay current with FDA guidance: Regulatory expectations are evolving. Human factors, software integration, and use-risk analysis are now central considerations in many combination product reviews.

With a proactive and informed approach, sponsors can reduce regulatory uncertainty, improve submission quality, and bring combination therapies to patients faster.

Celegence offers comprehensive regulatory consulting services tailored for combination products, providing strategic guidance on classification, regulatory submissions, and compliance with both drug and device regulations. Their expert guidance helps streamline development processes, mitigate risks, and facilitate timely market entry for complex combination therapies.

Clinical Evaluation Reports (CERs) are often associated with EU MDR, but an increasing number of manufacturers are now integrating CERs into their FDA submissions, particularly for devices requiring robust clinical evidence. This approach allows manufacturers to present a clear, comprehensive clinical evidence package, ensuring alignment with FDA expectations and reducing review timelines.

CERs in the Context of FDA Submissions

Unlike the EU MDR, the FDA does not mandate a standalone CER as part of a 510(k) or PMA submission. However, substantiating safety and performance of a device through clinical data is a fundamental expectation of the FDA. Clinical evidence plays a pivotal role in FDA review, especially for:

• Novel devices without predicates
• De novo applications
• Devices with high-risk profile
• PMA supplements requiring new safety data

What to Watch For: Common Pitfalls

1. Inadequate Clinical Data
   An unsystematic literature review may result in inclusion of irrelevant or inadequately appraised clinical data, or poorly analyzed data. Additionally, relying on EU-based data without appropriate consideration of its relevance to the U.S. clinical context can further weaken the submission.
2. Lack of Understanding of Submission Types
   Submitting the wrong type of application may lead to significant delays or rejection. Failing to understand the specific requirements associated with the chosen submission type can lead to missing critical information.
3. Unsubstantiated Clinical Claims
   If the clinical data does not directly support the intended use or labelling of the device, it may lead to questions from the reviewer or delays. Each safety and performance claim should be clearly substantiated with traceable evidence.
4. Underutilization of Real-World Evidence (RWE)
   Adverse event trends, registry data, and post-market studies provide real-world evidence that can further enhance the risk-benefit assessments. Not leveraging this data is a missed opportunity to strengthen the submission.
5. Lack of integration across submission sections
   Lack of alignment between clinical, risk, and labeling sections can make it difficult for reviewers to interpret the submission. Maintaining consistency across all sections is essential.

Considerations for a CER aimed at FDA Review

Although CERs are not mandated by FDA, manufacturers should consider the following when drafting a CER to support regulatory submissions:

• Discussion of data relevance, especially for U.S. population
• Clear summary of the clinical evidence, including published literature, registry data, and clinical trials
• Analysis of risks, adverse events, and benefits in alignment with device labeling
• Refer to FDA-recognized standards and guidance, like 21 CFR 814 or the Clinical Evidence Premarket Submission guidance

Useful Tools & Resources

Developing CER content for FDA submissions can be time-consuming, particularly when teams are handling multiple submissions or working under tight timelines. The following tools and data sources can help streamline the process:

• FDA MAUDE Database – for adverse event data and comparator analysis
• ClinicalTrials.gov – to identify relevant ongoing and completed clinical trials
• PubMed and Embase – to identify relevant peer-reviewed clinical literature
• FDA Guidance Documents – to align the CER content with FDA expectations
• FDA CDRH Learn – to stay updated on submission requirements and review trends

These resources are most effective when used strategically, supported by internal alignment and medical writing expertise.

How Celegence Supports CER Preparation for FDA Submissions

Preparing a CER or clinical justification for FDA review isn’t just about data gathering. It’s about crafting a clear, well-structured narrative supported by robust evidence. This is where Celegence adds value.

We combine regulatory expertise with technology to deliver submission-ready CERs, literature reviews, and clinical summaries—on time and in line with FDA expectations.

What sets us apart?

• Clinical writers experienced in FDA and EU submissions
• AI-powered literature reviews and data extraction using CAPTIS®
• Integration of FDA databases and guidance documents into writing workflows
• Quick turnaround times for 510(k), PMA, and De novo pathways
• 99% first-time acceptance rate of clinical documents by regulatory reviewers

Whether you need a literature-based justification, a full CER-style report, or gap analysis of your existing documentation—we offer flexible solutions for every stage of development and submission.

Let’s Work Together

Need help aligning your clinical evidence with FDA expectations? Celegence delivers accurate, regulatory-ready CER support backed by proven expertise and AI tools. Contact our team today to get started.

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The transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) represents a significant shift in the regulatory landscape for medical devices in the European Union, and has led to stricter requirements for clinical evidence. The European Union Medical Device Regulation (EU MDR) requires manufacturers to provide clinical evidence to demonstrate the safety and performance of their medical devices. This evidence is crucial for obtaining and maintaining CE marking, which allows devices to be sold in the EU.

[/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=”” awb-switch-editor-focus=”” 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=”20px” 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=””]What Is Clinical Evidence 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=”” awb-switch-editor-focus=”” 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=””]

As per EUMDR clinical evidence can be defied as clinical evaluation as “a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits of the device when used as intended by the manufacturer.” This evidence should be specific to the device of interest and should be able to demonstrate the safety and performance of the device.

The data can be from various sources like but not limited to:

• Data from clinical investigations: These can be performed by the manufacturer, mostly for high-risk devices to collect safety and performance data.
• Published Scientific literature: Article or publications in peer reviewed journals can also be used to provide clinical evidence for scientific devices.
• PMS data: These data reflect real world evidence for the device as they are collected once the device is launched in the market.
• AE databases/Registries: These databases provide specific data for the device related to the reported AE or other details also specifically in terms of registries

[/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=”” awb-switch-editor-focus=”” 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=”20px” 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=””]

When and Where Is Clinical Evidence Required

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Clinical evidence is required in both premarketing and post marketing phase of device lifecycle in EUMDR. In the premarket phase the manufacturer needs to collect data from clinical investigation and literature to assess the safety and performance of the device. In the post market phase real world clinical evidence can be collected to update the Clinical evaluation documents as necessary. All this data should be used in the CER and should be updated as necessary.

[/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=”” awb-switch-editor-focus=”” 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=”20px” 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=””]

What Standards or Thresholds Must Be Met?

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To be considered acceptable, clinical evidence must be:

• Device-Specific and Relevant: The data should be specific device and should be aligned to its intended purpose, target patient population, and risk profile. In terms of equivalence the equivalence should be clearly justified clinically, technically and biologically in the CER. Additionally, the data should be sufficient quantitively also.
• Scientifically Robust: Data must be of high-quality, credible, and considered from reliable sources such as clinical investigations, peer-reviewed literature, and structured literature reviews using recognized search methodologies.
• Continuously Updated: Clinical evidence is not static. The CER must be updated regularly, particularly when new risks emerge, performance data changes, or the device is modified. Also based on the device risk there is a review period after which the CER should be revised irrespective of any reasons mentioned before. Additionally, there should be ongoing surveillance for post marketing data for the devices.

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Who Verifies EU MDR Clinical Evidence?

The verification of clinical evidence is primarily conducted by Notified Bodies. These are organizations designated by EU member states to assess the conformity of medical devices with the MDR requirements. The review can be of clinical evaluation or technical documentation, on site review or even PMS audits.

The bar for clinical evaluation has risen significantly, and these bodies are increasingly strict about the sufficiency, traceability, and quality of the data.

Common Pitfalls in Clinical Evidence Preparation

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” awb-switch-editor-focus=”” 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 most common problem currently is the lack of proper clinical evidence to support safety and performance of the device. Another major challenge which is being currently faced by manufacturers is the lack of proper clinical investigation planning. Failing to implement a robust PMS plan or specific PMCF plan also leads to lack of clinical data for the device. Finally, inconsistent documentation, the technical document for a device should align in term of all internal information like intended purpose, claims, warnings precautions etc.

[/fusion_text][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” top_margin=”30px” alignment=”center” /][fusion_imageframe image_id=”23267|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Accelerate Clinical Evidence with CAPTIS®” 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/2025/05/Accelerate-Clinical-Evidence-with-CAPTIS®.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” top_margin=”30px” 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=”” awb-switch-editor-focus=”” 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=”20px” 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=””]

How Celegence Helps You Stay Ahead – Powered by CAPTIS^®

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At Celegence, we understand the weight clinical evidence carried under EU MDR. That’s why our regulatory experts, clinical writers, and technologists work together to ease this burden for device manufacturers.

Our proprietary platform, CAPTIS^®, supports every step of the clinical evidence development process:

• • AI-Powered Systematic Literature Reviews – CAPTIS^® uses intelligent algorithms to extract relevant data quickly and accurately, reducing manual effort and review cycles.
  • Automated Data Consistency Checks – CAPTIS^® ensures clinical data across documents is aligned, flagging inconsistencies before they’re submitted.
  • Advanced Search & Data Retrieval – From real-time adverse event databases to journal articles, CAPTIS^® connects you to the most relevant sources in moments.
  • Audit-Ready Documentation – The platform generates clear, traceable reports that meet the expectations of Notified Bodies.
  • Collaboration Tools – Clinical, regulatory, and quality teams can work together within CAPTIS^® to maintain alignment across documentation.

Combined with our expert writing and consulting services, we deliver fully MDR-compliant CERs, PMCF plans, and literature reviews—all with quick turnaround time.

[/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=”” awb-switch-editor-focus=”” 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=”20px” 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=””]

Partner With Celegence

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Clinical evidence under EU MDR doesn’t have to be a bottleneck. With the right partner—and the right tools—you can build submission-ready documentation that stands up to regulatory scrutiny.

Talk to our clinical evidence team today and reduce your compliance burden with confidence.

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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” min_height=”” link=””][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” top_margin=”30px” alignment=”center” /][fusion_imageframe image_id=”23203|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”How Celegence Leverages CAPTIS to conduct Efficient Benefit-Risk Analysis for 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=”” 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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/2025/04/Celegence-Leverages-CAPTIS-to-conduct-Efficient-Benefit-Risk-Analysis-for-Medical-Devices-1-1.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” top_margin=”30px” 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=”” awb-switch-editor-focus=”” 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=””]

How Celegence Leverages CAPTIS^® to conduct Efficient Benefit-Risk Analysis 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=”” awb-switch-editor-focus=”” 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=””]In the fast-paced world of medical device regulatory affairs, conducting a thorough benefit-risk analysis is a time-consuming yet critical task. At Celegence, we understand these challenges firsthand. That’s why we utilize CAPTIS^® our powerful AI-driven platform that streamlines literature reviews, automates adverse event data retrieval, and simplifies report writing. By leveraging cutting-edge technology, our medical writers deliver faster, more accurate, and regulatory-compliant reports, giving our clients a distinct advantage.[/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=”” awb-switch-editor-focus=”” 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=”20px” 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=””]

Why Choose Celegence for Your Benefit-Risk Analysis?

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” awb-switch-editor-focus=”” 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=””]

Medical writers often struggle with:

1. Scattered Data Sources: Managing literature references, risk assessments, and extracted data across multiple systems is inefficient.
2. Manual Data Extraction: Identifying risks and adverse events from literature takes time and is prone to human error.
3. Cumbersome Adverse Event Searches: Searching the FDA’s MAUDE database is a manual, fragmented process.
4. Time-Intensive Report Writing: Ensuring consistency across risk data, literature findings, and device descriptions requires significant effort.

At Celegence, we overcome these challenges using CAPTIS^®, allowing us to deliver benefit-risk analysis reports with unmatched speed and precision.

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How Celegence Uses CAPTIS® to Achieve Efficiency

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1. • Ensure Full Traceability: No more scattered information—every literature reference and review decision is stored in one place.
   • Identify & Tag Risks Seamlessly: Our writers tag risks and adverse events directly from literature sources, aligning them with risk files.
   • Leverage AI for Data Extraction: AI-powered prompts streamline data identification, allowing us to extract key risk-related information effortlessly.Literature Review Data – A Single Source of Truth: CAPTIS^® centralizes all literature references, review decisions, PDFs, and extracted data, enabling our medical writers to:
2. AI-Generated Summaries for Faster Analysis: CAPTIS^® enhances our workflow by automatically summarizing literature findings, ensuring:
   • Consistent and Comprehensive Reporting: AI-generated summaries align with regulatory requirements.
   • Accelerated Report Drafting: Instead of manually compiling literature data, our team focuses on strategic analysis, while CAPTIS^® handles the generation of literature tables and other data management tasks.
3. Automated MAUDE & TPLC Data Retrieval: Celegence uses CAPTIS^® to automate adverse event data retrieval from the FDA’s MAUDE and TPLC databases, offering:
   • Instant Access to Device Names with Reported Issues for the configured product codes.
   • Multi-Device and Manufacturer Selection for efficient searching.
   • Bypassing MAUDE’s 500-Result Constraint for full data retrieval.
   • One-Click Data Downloads for streamlined reporting.
   • Device vs Industry Totals, a functionality not available on the FDA website.
4. Faster, More Accurate Report Writing & Review: With CAPTIS^®, Celegence streamlines the entire report-writing process:
   • Integrated Source Document Linking: Product information, device descriptions, and risk data are included directly from the source files with automatic content links to the original content location.
   • Effortless Multi-Department Collaboration: Our report writing module allows seamless collaboration to include contributions from risk teams, medical affairs, R&D, PMS, and external experts.
   • Accelerated Review Process: Content links enable instant traceability, speeding up reviews and approvals.
   • AI-Powered Literature Summaries and Extractions: Our team uses AI prompts to align literature summarization with benefit-risk analysis requirements, improving accuracy and efficiency.

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Why Work With Celegence?

[/fusion_title][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”” rule_size=”” rule_color=”” hue=”” saturation=”” lightness=”” alpha=”” user_select=”” awb-switch-editor-focus=”” 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=””]

At Celegence, we don’t just write reports—we optimize the entire drafting process using advanced AI-powered technology. Our team, equipped with CAPTIS^®, ensures that your reports are comprehensive, accurate, and delivered faster than traditional methods.

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Partner with Us for Best-in-Class Benefit-Risk Analysis

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Ready to experience the efficiency of AI-driven benefit-risk analysis? Partner with Celegence today and let our technology-enabled medical writers streamline your regulatory documentation. Contact us at info@celegence.com for a consultation and see how we can enhance your reporting process!

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Enhancing Systematic Literature Reviews for Adverse Events with AI

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The primary pillar of the EU MDR is patient safety. Irrespective of the risk classification or nature of device, all devices are expected to meet rigorous safety standards to ensure that they do not cause any harm to patients. One of the most effective ways of ensuring device safety is through adverse event reporting. One of the primary sources of identifying adverse events related to device use is literature. A systematic literature review is a methodical, structured process for gathering, screening, extracting data and synthesizing research on a specific topic. The goal is to uncover patterns, gaps, and trends in the available evidence.

Unlike traditional reviews or essays, an SLR follows a set process that includes defining research questions, selecting studies, and assessing their quality and relevance. Systematic literature reviews are essential for compiling data on the safety and performance of the medical device into its Clinical Evaluation Reports (CER) to meet regulatory requirements. These reviews provide a thorough and unbiased assessment of the safety and performance of medical devices by analyzing data from multiple sources.

The process involves several key steps:

• Literature Search: Identifying relevant studies from various databases such as PubMed, Embase, and Cochrane. Identification is facilitated by defining a research objective and defining appropriate keywords and search strings to pull the most appropriate results on the topic of interest.
• Screening: Filtering studies based on predefined inclusion and exclusion criteria.
• Data Extraction: Extracting relevant data, including study type, study subjects, demographics, interventions used, performance outcomes of interest and adverse events.
• Data Synthesis: Summarizing and synthesizing the extracted data to draw meaningful conclusions.

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Challenges in Conducting SLRs

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Conducting systematic literature reviews is a time-consuming and labor-intensive process. It requires an elevated level of accuracy and attention to detail to ensure that all relevant studies are included and correctly evaluated. The sheer volume of literature to be reviewed can be overwhelming for regulatory professionals leading to inefficiencies, delays, and compliance risks especially when traditional manual methods are applied. Improperly analyzed and presented, specifically presenting missing or partial data, can create a skewed understanding of the true safety risks associated with a device, leading to gaps in safety assessment. Manual data extraction, since subjective, is also often associated with inconsistent interpretation of adverse events, especially when it comes to complex medical terminology or subtle details.

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Leveraging Advanced Tools for SLRs

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At Celegence, we leverage advanced tools like CAPTIS^® to streamline the SLR process. CAPTIS^® is an AI-powered platform that automates many of the labor-intensive tasks involved in SLRs. Here’s how CAPTIS^® enhances the SLR process:

• Automated Literature Search and Screening: CAPTIS^® quickly searches and de-duplicates identified literature from a multitude of different databases. CAPTIS^® allows for automatic download and storage of articles where the full text is available freely online making the analysis easier with immediate access to data. With the use of specific keywords CAPTIS^® can also highlight potentially relevant or irrelevant articles. This significantly reduces the time and effort required for the different stages of the review process.
• Data Extraction and Summarization: CAPTIS^® automatically extracts relevant information from research articles, such as study type, study subjects, demographics, interventions used, and adverse events. This information is summarized within seconds, allowing medical writers to be more efficient and consistently meet deadlines. CAPTIS^® also facilitates identification and extraction of adverse events in a way that reduces or eliminates the subjectivity and inconsistencies when handling large data sets manually.
• Enhanced Collaboration: CAPTIS^® enables seamless collaboration and communication among team members. From literature search to screening and appraisal, team members can collaborate and leave feedback on the platform itself

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Case Study: AI-Powered SLRs at Celegence

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In a recent project, Celegence utilized CAPTIS^® to conduct an SLR for a medical device manufacturer. The AI-powered platform automated the literature search, facilitated faster screening, and automated the data extraction processes, reducing the time required for the review by an impressive 60%. The data extracted was also presented consistently despite being a large volume negating the need for additional time to be spent on standardizing the content prior to data analysis.

This allowed the regulatory team to focus on data synthesis and analysis, ensuring a thorough and accurate evaluation of adverse events.

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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/2025/04/Why-Literature-Reviews-Should-Be-Done-with-CAPTIS®.jpg[/fusion_imageframe][fusion_separator style_type=”none” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” top_margin=”30px” alignment=”center” /][/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” 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Driving Safer, Smarter Reviews with AI-Powered Precision

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Systematic literature reviews are a critical component of regulatory compliance for medical devices. By leveraging advanced tools like CAPTIS^®, regulatory professionals can streamline the SLR process, improve efficiency, and ensure compliance with regulatory requirements. At Celegence, we are committed to providing innovative solutions that enhance the safety and performance of medical devices, ultimately improving patient outcomes.

See how our AI-powered solutions can transform your regulatory processes. Contact us at info@celegence.com to learn more.

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Clinical Evaluation Report Template and CAPTIS^®

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Clinical evaluation for medical devices is a systematic process that is used to assess the safety and performance of a medical device by analysing clinical and non-clinical data. This evaluation helps demonstrate compliance with the existing regulatory requirements. It also helps in demonstrating that the device is safe to use and performs when used as per the manufacturer’s instructions. The process of evaluation of a device clinically is continuous and continues till the device lifetime. To keep the data up to date periodic revision is done along with the revision of associated documents like Post marketing survey documents (PMSR, PMSP etc).

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Key Documents in the Clinical Evaluation Process

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For documenting this process of clinical evaluation, a Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) for the medical device is created. While a CEP summarizes the process of clinical evaluation necessary for obtaining CE (conformité européenne) mark for the device, and provides in detail the pathway taken, a CER analyses data from multitude of sources like post marketing data, literature, adverse event databases, clinical trials etc. This process makes sure that the device meets regulatory requirements and is safe and effective for its intended use.

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For documenting this process of clinical evaluation, a Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) for the medical device is created. While a CEP summarizes the process of clinical evaluation necessary for obtaining CE (conformité européenne) mark for the device, and provides in detail the pathway taken, a CER analyses data from multitude of sources like post marketing data, literature, adverse event databases, clinical trials etc. This process makes sure that the device meets regulatory requirements and is safe and effective for its intended use.

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Structure and Content of a Clinical Evaluation Report

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The document is created in a template compliant to EUMDR. Medical Device coordination Group (MDCG 2020-13) provides a Clinical Evaluation Assessment Report (CEAR) template which is useful while creating the document. Major sections for the CER include:

• Executive Summary
• Background/Introduction
• Device Description
• Data Held by Manufacturer and External Data
• Data Analysis Including Risk-Benefit Analysis
• Conclusions

The sections within a CER are deeply interconnected, each contributing to the overall assessment of a medical device’s compliance with EU MDR. From the device description and clinical data to benefit-risk analysis and post-market surveillance, the information in each section flows seamlessly, supporting the next. This interconnectedness ensures a cohesive narrative, where each section reinforces the others, ultimately leading to a well-supported conclusion that demonstrates the device’s safety, performance, and regulatory compliance.

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CAPTIS^®: Simplifying the Clinical Evaluation Report Process

Celegence CAPTIS^® is designed to navigate this complexity of the CER sections. It is designed to cater to the needs of medical device manufacturers of all sizes, helping them achieve compliance with EU MDR and IVDR regulations more efficiently. It is a compliance software tool designed to streamline the creation of various regulatory documents for medical devices, including Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PERs), Summary of Safety and Clinical Performance (SSCPs), and Periodic Safety Update Reports (PSURs).

How CAPTIS^® Enhances CER Development

Using CAPTIS^® in CER offers multiple advantages. CAPTIS^® helps to manage the vast amount of source documents required to add the data in the sections, literature search and database integration like Adverse Event (AE) database integration and an automated template where the common data like device name is automatically filled in the CER leading to substantial time saving. The template in CAPTIS^® can also be modified and is downloadable at any point during creation of the document.

Key CAPTIS^® Features for CER Efficiency

As with the interface being straightforward and easy to navigate and the use of templates and automated literature reviews, it is ensured that information is presented consistently across all documents. The automated literature module integrates seamlessly with databases like PubMed and Google Scholar which helps in easy retrieval and screening of relevant literature in turn reducing manual effort. The platform also integrates with AE databases like MAUDE, TPLC which are a major part of risk analysis for the CER.

Additionally, CAPTIS^® also helps in the editorial side of the document, ensuring use of predefined templates, automatic creation of abbreviation tables, keyword dictionary etc. Last but not least, CAPTIS^® also provides features for commenting, version control, and centralized documentation, facilitating collaboration among team members and ensuring that all contributions are traceable and auditable.

Streamlining Regulatory Compliance with CAPTIS^®

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These features substantially decrease manual effort and chances of error, thereby increasing the efficiency and accuracy of CERs. This makes it easier for manufacturers to create complex regulatory documents for their medical devices.

Contact us at info@celegence.com to learn more.

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