Drug-Led vs. Device-Led Combination Products: Determining the Primary Mode of Action (PMOA)

20 May, 2025

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:

Feature	Drug-Led Combination Product	Device-Led Combination Product
Primary Mode of Action (PMOA)	Chemical or metabolic action	Physical or mechanical action
Lead FDA Center	CDER or CBER	CDRH
Submission Pathway	IND → NDA/BLA	Q-Sub → IDE (if needed) → 510(k), De Novo, or PMA
Regulatory Focus	Drug efficacy, safety, pharmacology	Device performance, engineering, standards
Example	Prefilled syringe of a monoclonal antibody	Drug-eluting coronary stent

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:

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.
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.

Beyond Europe: The Strategic Value of CERs in FDA Submissions

14 May, 2025

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

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.
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.
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.
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.
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.

EU MDR Clinical Evidence: Meeting the Mark for Regulatory Compliance

05 May, 2025

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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=”” 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=””]EU MDR Clinical Evidence: Meeting the Mark for Regulatory Compliance[/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=”” 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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

When and Where Is Clinical Evidence Required

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.

What Standards or Thresholds Must Be Met?

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

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.

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

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.

Partner With Celegence

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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How Celegence Leverages CAPTIS® to conduct Efficient Benefit-Risk Analysis for Medical Devices

15 Apr, 2025

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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=”” 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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?

Medical writers often struggle with:

Scattered Data Sources: Managing literature references, risk assessments, and extracted data across multiple systems is inefficient.
Manual Data Extraction: Identifying risks and adverse events from literature takes time and is prone to human error.
Cumbersome Adverse Event Searches: Searching the FDA’s MAUDE database is a manual, fragmented process.
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.

How Celegence Uses CAPTIS® to Achieve Efficiency

- 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:
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.
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.
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.

Why Work With Celegence?

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.

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

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

03 Apr, 2025

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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=”23142|full” aspect_ratio=”” custom_aspect_ratio=”100″ aspect_ratio_position=”” skip_lazy_load=”” lightbox=”no” gallery_id=”” lightbox_image=”” lightbox_image_id=”” alt=”Streamline Adverse Event SLRs with AI-Powered 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=”” 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Enhancing Systematic Literature Reviews for Adverse Events with AI

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.

Challenges in Conducting SLRs

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.

Leveraging Advanced Tools for SLRs

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

Case Study: AI-Powered SLRs at Celegence

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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link=””][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=”18px” 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” 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Driving Safer, Smarter Reviews with AI-Powered Precision

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®

24 Mar, 2025

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Clinical Evaluation Report Template and CAPTIS^®

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).

Key Documents in the Clinical Evaluation Process

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

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^®

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.

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How AI Speeds Up Systematic Literature Reviews by 60%

04 Feb, 2025

How AI Speeds Up Systematic Literature Reviews by 60%

Systematic Literature Reviews (SLR), also known as Literature Search Reviews (LSR), play a vital role in ensuring compliance with stringent regulations such as the EU MDR. However, the traditional process of conducting SLRs, often performed by Medical and Clinical Affairs teams manually, is the most time-consuming and labor-intensive component of CERs. Enter AI-powered solutions, which are revolutionizing the way we approach SLRs, speeding up the process by an impressive 60%.

The Challenge of Systematic Literature Reviews

Systematic Literature Reviews are essential for compiling Clinical Evaluation Reports (CER) and meeting regulatory requirements. These reviews involve meticulously searching, screening, and analyzing vast amounts of scientific literature to ensure that medical devices are safe and effective. The process is not only time-consuming but also requires a high level of accuracy and attention to detail.

How AI is Transforming SLRs

AI-powered tools are changing the game by automating many of the labor-intensive tasks involved in SLRs. For instance, AI can quickly search and screen literature, identify relevant studies, and even extract data, significantly reducing the time and effort required. With a direct connection to databases, integration into the Literature Module, automations, simultaneous review by multiple reviewers, and other features, AI makes this tedious process immensely easier, taking the burden off SMEs.

Benefits of AI in SLRs

AI tools can process large volumes of data much faster than humans, reducing the time required for literature searches and reviews. AI algorithms can identify relevant studies with high precision, minimizing the risk of missing important information. AI ensures that the review process is consistent and reproducible, which is crucial for regulatory compliance. By automating repetitive tasks, AI reduces the need for manual labor, leading to cost savings.

Challenges Faced Before Using CAPTIS®

Before the introduction of CAPTIS®, our medical writers and regulatory professionals faced several challenges in conducting SLRs. The traditional process was highly manual, involving extensive literature searches, data extraction, and documentation. This often led to:

Time Constraints: The manual nature of the process meant that literature reviews could take weeks or even months to complete, putting pressure on teams to meet tight deadlines.
Data Management: Handling vast amounts of data from multiple sources was cumbersome and prone to errors. Ensuring the accuracy and consistency of the data was a significant challenge.
Collaboration Issues: Coordinating efforts among team members was difficult, with feedback and updates often getting lost in lengthy email chains or disparate documents.
Regulatory Compliance: Meeting the stringent documentation requirements of regulatory bodies required meticulous attention to detail, which was time-consuming and labor-intensive.

Celegence’s Approach to AI-Powered SLRs

At Celegence, we leverage our in-house AI medical writing platform, CAPTIS®, to streamline the SLR process. CAPTIS Copilot, an AI integration within the Literature module, 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.

From literature search to screening and appraisal, CAPTIS® enables seamless collaboration and communication among team members. “From the literature search to the screening and appraisal performed on the platform and the documents that have been authored on CAPTIS, I can collaborate and communicate with the author and leave my feedback on the platform itself. The author can request for verification of actions performed and I can provide my updates after my review,” Celegence medical writer explained.

The data dictionary and automated reports generated by CAPTIS® make the review process more effective and the content more accurate. The content linking feature allows users to cross-verify data from source documents with just one click. Additionally, multiple reviewers can review a single document simultaneously, bringing efficiency to the process. “The features of data dictionary and automated reports that have been generated make the review process more effective and the content added more accurate. The content linking feature allows me to cross-verify the data that’s been added from the source documents in just one click. Multiple reviewers can review a single document simultaneously which brings efficiency to the process,” the medical writer added.

Conclusion

AI is transforming the way we conduct Systematic Literature Reviews, making the process faster, more accurate, and more efficient. By leveraging AI-powered tools like CAPTIS®, medical device professionals can ensure compliance with regulatory requirements while saving time and resources. Stay ahead of the curve by embracing AI in your SLR process. See how our AI-powered solutions can transform your regulatory processes. Contact us at info@celegence.com to learn more.

Mastering Benefit-Risk Analysis for EU MDR Compliance

24 Jan, 2025

Mastering Benefit-Risk Analysis for EU MDR Compliance

Benefit-risk analysis is a cornerstone of compliance for medical device manufacturers under the EU MDR. This rigorous process evaluates whether the benefits of a device outweigh its associated risks, ensuring patient safety and regulatory approval. With the increasing complexity of medical devices and evolving regulations, understanding and implementing effective benefit-risk analysis is critical.

But what does it take to successfully navigate these complexities? In this blog, we delve into insights shared during a recent webinar to explore key methodologies, tools, and best practices to excel in this domain.

Understanding Benefit-Risk Analysis

Benefit-risk analysis is not a one-time activity but a continuous process integrated throughout a device’s lifecycle. Its primary goal is to demonstrate that the benefits of a device significantly outweigh its risks, thereby justifying its acceptability for patient use. Key regulatory frameworks guiding benefit-risk assessments include:

EU MDR Article 2 and GSPR 2 and 8: These articles outline essential definitions and data presentation requirements for demonstrating acceptability.
ISO 14971: Offers comprehensive guidelines for risk management, including identifying, assessing, and mitigating risks.
MDCG 2026 Guidance: Provides clinical evaluation pathways for effective benefit-risk analysis.
MedDev 2.7.1 Revision 4: Offers examples and distinctions between qualitative and quantitative assessments.

By aligning benefit-risk analysis with these frameworks, manufacturers ensure their devices meet regulatory expectations while prioritizing patient safety. Now, let’s take a closer look at the key components that form the foundation of an effective benefit-risk assessment.

Key Components of Benefit-Risk Analysis

An effective benefit-risk analysis revolves around several fundamental components:

Benefit: Represents the positive impact on patient health, such as improved diagnosis, management, or treatment outcomes. Benefits can be direct (e.g., life-saving interventions) or indirect (e.g., aiding clinicians in decision-making).
Risk: Combines the probability of harm occurring with the severity of that harm. Risks could range from mild side effects to serious adverse events.
Residual Risk: The remaining risk after mitigation measures have been applied. It’s crucial to acknowledge and document these risks transparently.
Benefit-Risk Ratio: A comparative measure that evaluates whether the benefits justify the associated risks, expressed in qualitative or quantitative terms.

These components provide the building blocks for a robust analysis. But why is this process so important for manufacturers and regulators alike? Let’s explore the broader significance of benefit-risk analysis.

Why Benefit-Risk Analysis Matters

Conducting a robust benefit-risk analysis is crucial for several reasons:

Ensuring Patient Safety – The primary purpose of medical devices is to enhance patient outcomes. Benefit-risk analysis ensures that devices provide more good than harm, identifying potential risks and addressing them proactively. This approach is an ethical obligation for manufacturers and healthcare providers alike.
Regulatory Compliance -Under the EU MDR, benefit-risk analysis is a mandatory component of Clinical Evaluation Reports (CERs) and risk documentation. Regulators demand detailed justifications of the benefit-risk profile, supported by clinical evidence, to approve devices for market use. A weak analysis could result in delays or rejections.
Informed Decision-Making – Benefit-risk assessments provide valuable insights for clinicians and patients, enabling informed choices. For example, identifying contraindications or subpopulations where a device’s risks outweigh its benefits helps tailor its use to appropriate cases.
Facilitating Continuous Improvement – Real-world performance data collected post-market can highlight areas for improvement. Benefit-risk analysis allows manufacturers to refine device design, labeling, or risk control measures to align with state-of-the-art practices and maintain a competitive edge.

Understanding the importance of benefit-risk analysis sets the stage for examining the methodologies that bring it to life. How do manufacturers choose the right approach for their devices? Let’s explore.

Methodologies for Benefit-Risk Analysis

Benefit-risk analysis can be conducted using qualitative or quantitative approaches, depending on the device’s risk class, clinical data availability, and intended use. Let’s explore these methodologies in detail:

1. Qualitative Analysis

Qualitative analysis relies on descriptive terms rather than numerical data to evaluate benefits and risks. This approach is ideal for low-risk devices or those with indirect benefits. Examples include:

Devices with Indirect Benefits: Diagnostic tools or assistive devices that support better decision-making for clinicians.
Procedural Efficiency: Devices improving healthcare workflows or reducing recovery times.

Common Parameters in Qualitative Analysis:

End-User Benefits: How the device supports healthcare providers or caregivers.
Quality of Life Improvements: Enhancements in patient well-being due to reduced recovery times or improved procedural outcomes.
Minor Risks: Usability challenges or procedural complications that are easily manageable.

Example: A wound bandage’s qualitative analysis might highlight benefits like enhanced healing environments while documenting minor risks such as skin irritation.

For devices with higher complexity or risk, however, qualitative analysis may not suffice. This brings us to quantitative methodologies.

2. Quantitative Analysis

Quantitative analysis employs statistical and numerical methods to provide a data-driven evaluation of benefits and risks. This method is crucial for high-risk devices where objective evidence is essential.

Techniques for Quantitative Analysis

Benefit-Risk Ratio: Compares the frequency and severity of benefits versus risks.
NNT (Number Needed to Treat) vs. NMH (Number Needed to Harm): Calculates how many patients need treatment to observe one benefit or one harm, respectively.
QALY (Quality Adjusted Life Years): Quantifies both the quality and duration of life improvements a device offers.

Example: For a cardiac stent, if the NNT is 25 (indicating significant benefit) and the NMH is 200 (indicating low harm likelihood), the device’s favorable profile supports its use.

Both approaches play a critical role in addressing the challenges manufacturers face during regulatory submissions. Let’s examine common hurdles and how to overcome them.

Challenges Highlighted by Notified Bodies

Notified bodies frequently flag common shortcomings in benefit-risk assessments, such as:

Insufficient Clinical Evidence: Broad claims unsupported by targeted, robust data.
Incomplete Risk Characterization: Missing details about risk severity, likelihood, or affected patient populations.
Over-Reliance on Qualitative Analysis: Lack of quantitative insights to substantiate benefit-risk profiles for high-risk devices.
Documentation Inconsistencies: Misalignment across CERs, risk management files, and post-market surveillance reports.

By addressing these gaps, manufacturers can strengthen their submissions and ensure alignment with regulatory expectations.

Celegence’s Role in Simplifying Benefit-Risk Analysis

Celegence leverages innovative tools like CAPTIS® to streamline the benefit-risk assessment process. CAPTIS integrates:

Literature reviews and adverse event data.
Automated alerts for document updates.
Advanced search capabilities for discrepancy detection.

By centralizing data and automating workflows, CAPTIS saves time, reduces errors, and ensures comprehensive regulatory submissions. With these tools, manufacturers can focus on delivering safe and effective devices without getting bogged down in complex processes.

Conclusion

Benefit-risk analysis is integral to both patient safety and regulatory success under the EU MDR. By employing the right methodologies—whether qualitative or quantitative—and leveraging cutting-edge tools, manufacturers can confidently navigate regulatory challenges and demonstrate their commitment to delivering safe and effective medical devices.

The question now is: Are you equipped to master your benefit-risk analysis? Contact Celegence to learn how we can support your regulatory needs.

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Medical Writers’ Experience: AI and Automation Transform Regulatory Workflows – Q&A

28 Nov, 2024

EU MDR and IVDR have created many new challenges for medical writing and regulatory affairs professionals. An increased workload, combined with the scarcity of expert resources, makes it essential to find innovative solutions that maintain efficiency and prevent burnout among highly skilled teams. How does use of technology help?

AI-driven tools and automations enhance productivity, ensure consistency, and simplify the complex regulatory processes, allowing professionals to focus on analytical work instead of repetitive tasks.

Celegence has interviewed medical writers and asked them about practical advantages of such technologies. Here is what they shared about their experience using CAPTIS® medical writing platform:

Q: How does a medical writing platform improve your day-to-day as a medical writer?

A: Workflow is significantly improved by centralizing all reference documents, literature search results, and automated reports in one place. It also means data is easily traceable. Its customized templates save time and streamline periodic updates, helping manage complex regulatory requirements more efficiently.

One of the standout features is its ability to configure style templates, ensuring that all content, tables, figures, headers, and footers are automatically formatted and consistent when exported to Word. Medical writers can rely on CAPTIS® for the mechanical aspects of writing, freeing them to focus on the analytical process.

Q: How does it help maintain consistency in information throughout various documents such as the CER, SSCP, etc.?

A: Features such as the user-friendly interface and data dictionary ensure consistency in critical data and text, while the ability to leave comments and feedback across all modules helps maintain accuracy in documents.

Q: How can the device industry keep up with the resource challenges posed by EU MDR & IVDR?

A: Increased documentation requirements under the EU MDR & IVDR are putting a strain on our industry’s expert resources. To prevent burnout and make better use of our skilled teams, investing in technological solutions is crucial, as it alleviates pressure through automation and AI. With the ability to modify and augment archived search strings, results, and screenings, document maintenance is streamlined and highly efficient.

Q: How does AI save up to 60% of time on literature search reviews?

A: By linking directly to multiple databases and allowing uploads from others, literature reviews are far more efficient and accurate than a manual process. The AI-enabled literature module, known as CAPTIS® Copilot, automatically extracts and summarizes relevant information from research articles in seconds. This significantly reduces research workload and helps writers consistently meet deadlines.

Among other things, it’s designed with input from medical writers. The platform addresses specific pain points like automatic generation of abbreviations, PRISMA flow charts, and automatic contents table updates.

Q: How do you now perform regulatory audits?

A: CAPTIS® provides a single source of truth, systematically collating and analyzing data to minimize non-conformances and streamline the certification process. With the AI feature writers have confidence that they can quickly find the information they need, supporting data analysis, and enhancing the quality of their documents.

Q: How does the citation manager tool work?

A: By enabling collaboration with other authors and reviewers, the whole process is more productive. Other features, such as the data dictionary, automated reports, and content linking, enhance the review process and ensure that content is accurate.

Q: How do you review documents and collaborate?

Watch the full interview here

Want to explore how CAPTIS® can streamline your workflow and enhance your productivity? Visit Celegence website to arrange a consultation or a demo.

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

Why Clinical Evaluation Reports (CERs) are Challenging and How Celegence Can Streamline the Process

10 Oct, 2024

Clinical Evaluation Reports (CERs)

Clinical Evaluation Reports (CERs) are a crucial component in the regulatory submission process for medical devices, especially in markets like the European Union, where compliance with the EU Medical Device Regulation (EU MDR) is mandatory. These reports serve as documented evidence to establish that a medical device meets the required safety and performance standards.

However, for many manufacturers, preparing and maintaining CERs can be a daunting task. From navigating ever-evolving regulatory requirements to conducting rigorous literature reviews, the process of creating a CER is resource-intensive and often overwhelming. In this blog, we explore why CERs present such significant challenges to medical device companies and how Celegence can help streamline the process with expert consulting services and innovative solutions.

Why are CERs considered Problematic?

Navigating Complex and Evolving Regulatory Requirements: One of the biggest challenges in creating CERs is staying up-to-date with the ever-changing regulatory landscape. Different markets have specific regulations, and these go through updates quite often, which add additional complexity to the process. For instance, with the introduction of the EU MDR, the requirements for clinical data have become more stringent, making it difficult for manufacturers to maintain compliance without constant regulatory vigilance and post market surveillance (PMS).

It is the expectation that manufacturers need to continuously monitor any updates to the regulations that are applicable to their devices, any guidance documents that may have to be referred to, and expectations from the Notified Bodies based on previous review experiences. As stated earlier, the EU MDR has heightened the requirements for robust and relevant clinical evidence, particularly for higher-risk devices. There is an increased demand and expectation for post-market clinical follow-ups (PMCF) and systematic evaluations of clinical data, which adds an additional layer of complexity to an already complicated process.

The process of gathering sufficient clinical data for a CER is often one of the most challenging aspects for medical device manufacturers. Many devices, especially legacy devices, and low-risk devices, may lack the clinical data required by the current regulatory standards. Moreover, the collection of high-quality, robust, relevant, and up-to-date clinical data can be a time-consuming and costly endeavor.

Another critical component of CERs is the systematic literature review process. Conducting a comprehensive review that meets regulatory standards requires specialized skills and access to extensive databases. Even then, ensuring that the literature review is thorough and includes all relevant data points can be a significant hurdle. For medical devices that have been on the market for several years, as well as for low-risk devices, and devices used in conjunction with other medical devices, it can be especially difficult to find relevant studies or clinical and technical data that align with the product’s intended use and safety profile.

Creating a CER is not a one-time activity; it requires ongoing efforts to assess relevant clinical data, maintain compliance, update reports, and respond to regulatory body feedback. The process demands a combination of specialized knowledge in regulatory affairs, clinical research, and literature analysis, making it a resource-intensive process for manufacturers.

Furthermore, manufacturers must ensure that the content presented in their CERs are consistent across all documentation that are to be submitted to the Notified Bodies. This means, there is the expectation of close attention to detail, and frequent updates as and when new clinical data becomes available. The need for resources to perform these activities, whether internal or through outsourcing, can place a considerable burden on small to medium-sized manufacturers, who often lack the internal bandwidth to manage these tasks effectively.

How long does it take to create a CER?

The timeline to author and develop a CER depends on multiple factors; most essentially the risk classification of the devices, the amount of available data (both internal and external), whether the device is already established or new to the market, etc. Based on Celegence’s experience, the example depicted below presents a standard timeline that is required for developing a CER.

As per MEDDEV 2.7.1 Rev 4, clause 6.2.3, a CER is required to be updated at least annually for high-risk or newly established devices, and every 2 to 5 years for lower risk, well-established devices. This frequency also varies in the following scenarios:

New information is received from the post market surveillance that has the potential to change the current evaluation process;
Any updates to the design of the device or manufacturing process which impacts the safety and performance of the medical device;
Any new risks identified from literature or other sources of data that affect the safety and performance of the device.

Based on the parameters stated above, the manufacturer must decide the frequency of update of the CERs.

How Celegence Can Help Simplify the process of CER Development

At Celegence, we understand the complexities associated with navigating the regulatory landscape for medical devices. Our team of experts offer tailored consulting services to help medical device manufacturers meet regulatory requirements efficiently. Whether your organization is struggling with data collection, literature reviews, or regulatory submissions, our consultants can guide you and provide the expertise you need.

We specialize in helping clients comply with the most stringent requirements under EU MDR. By partnering with Celegence, you gain access to a team of regulatory professionals who stay up to date with the latest industry regulations and Notified Body expectations. This ensures that your CERs are not only compliant but also tailored to meet the specific needs of your medical device based on the risk classification and market.

AI-Enabled Tools for Efficient Systematic Literature Review

One of the standout features of Celegence’s service offering is our AI-enabled systematic literature review solution. Traditional literature reviews are time-consuming and prone to human error. Our AI-powered tools streamline the data extraction process, enabling faster and more accurate reviews, while reducing the burden on your internal resources.

With Celegence’s technology, medical device manufacturers can focus on clinical data that truly matters. Our AI algorithms sift through thousands of documents to identify the most relevant studies and data points, ensuring a more efficient and thorough literature review. This ultimately helps speed up the CER development process, allowing companies to submit their reports faster and with greater confidence with respect to the accuracy and comprehensiveness of the data.

Tailored Solutions for Medical Device Manufacturers

No two medical device manufacturers are the same, and neither are their regulatory needs. To address this individualistic requirement, Celegence offers tailored solutions which combat the unique challenges faced by our clients. Whether you need assistance with the entire CER process or just specific aspects like literature reviews or post-market clinical follow-ups (PMCF), Celegence provides flexible and scalable solutions that can be adapted to your needs.

In addition to providing regulatory consulting and literature review services, Celegence helps manufacturers reduce compliance costs over time. We work with your internal teams to optimize the CER development process, implement cost-effective solutions, and provide insights into how our AI-enabled software can further streamline compliance efforts.

Conclusion: Streamlining CERs for Faster Market Access and Regulatory Success

Creating and maintaining compliant CERs is both challenging and resource-intensive, requiring manufacturers to balance stringent regulatory demands with efficiency. However, these hurdles can be overcome with the right expertise and tools.

Partnering with Celegence provides you access to skilled and experienced regulatory consultants, AI-driven solutions, and access to tailored support, to streamline your CER process. From navigating complex regulations to conducting systematic literature reviews, our specialists ensure your CERs are compliant with EU MDR requirements, enabling faster regulatory approvals and confident market entry.

Are you facing challenges with your Clinical Evaluation Reports? Contact Celegence today to learn how we can help you navigate the complexities of CER preparation and ensure regulatory success.

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Medical Writers’ Experience: AI and Automation Transform Regulatory Workflows – Q&A

Q: How does a medical writing platform improve your day-to-day as a medical writer?

Q: How does it help maintain consistency in information throughout various documents such as the CER, SSCP, etc.?

Q: How can the device industry keep up with the resource challenges posed by EU MDR & IVDR?

Q: How does AI save up to 60% of time on literature search reviews?

Q: How do you now perform regulatory audits?

Q: How does the citation manager tool work?

Q: How do you review documents and collaborate?

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