Your gap analysis started with the wrong baseline

Written by HATEM RABEH, MD, MSc Ing

Your Clinical Evaluation Expert And Partner

in
S

I have reviewed dozens of gap analyses over the past three years. The pattern is consistent. Manufacturers list MDR requirements in one column, mark what documentation exists in another column, and highlight the missing pieces in red. The output looks complete. The spreadsheet is organized. Management sees progress.

Then the Notified Body review arrives. The gap analysis is rejected not because it missed requirements, but because it failed to assess the actual quality and adequacy of existing evidence. A checkmark that says “clinical evaluation report exists” tells you nothing about whether that report meets MDCG 2020-5 or whether its equivalence claims are defensible under MDR Article 61(5).

This is where most gap analyses fail. They focus on presence, not substance.

What Gap Analysis Actually Means Under MDR

MDCG 2020-6 describes gap analysis as a structured comparison between the clinical evidence available for a legacy device and the clinical evidence requirements under MDR. This is not a documentation audit. It is a clinical evidence adequacy assessment.

The distinction matters because you can have a complete set of documents that collectively fail to meet MDR standards. A clinical evaluation report written in 2015 under MDD may formally exist, but if it relies on literature searches limited to device name, if it claims equivalence without demonstrating technical and biological characteristics are equivalent, or if it contains no analysis of long-term safety, then it does not satisfy MDR requirements.

The gap is not that you lack a document. The gap is that the clinical evaluation itself is insufficient.

Starting Point: Assess What You Actually Have

Before you map MDR requirements, assess the clinical evidence foundation you are working from. This means reviewing the existing clinical evaluation in detail.

Ask the following questions:

Is there a clinical evaluation report at all?
Some legacy devices were placed on the market under MDD with no formal clinical evaluation report. The assumption was that equivalence or literature alone was sufficient, and no consolidated analysis was documented. If no report exists, your gap is total. You are starting from zero.

Does the report follow MDD Annex X or MDR Annex XIV Part A?
MDD required demonstration of conformity with essential requirements. MDR requires demonstration of safety and performance, benefit-risk analysis, and state of the art consideration. These are not the same framework. If your existing report is structured around MDD Annex X, it will require substantial rework, not minor updates.

What clinical data does the report rely on?
If the report is based entirely on equivalence to another device, you need to assess whether that equivalence claim is valid under MDR Article 61(5). If it relies on literature, you need to assess whether the search strategy, appraisal, and analysis meet current MDCG standards. If it includes clinical investigation data, assess whether the study design and reporting align with MDR requirements.

This is not a checkbox exercise. You are assessing the robustness of the clinical foundation.

Map the MDR Requirements With Precision

Once you understand what clinical evidence you currently have, map the MDR requirements at a granular level. Do not use high-level categories like “clinical evaluation” or “risk management.” Break down each requirement into its components.

For clinical evaluation under MDR Annex XIV Part A, this means mapping:

• Identification and description of the device and its intended use
• Identification of the relevant GSPR and applicable standards
• Definition of the scope of the clinical evaluation
• Clinical background and state of the art
• Clinical data from equivalence, literature, or investigations
• Appraisal of clinical data for safety and performance
• Benefit-risk determination
• Conclusion on demonstration of conformity

Each of these components has specific expectations. MDCG 2020-5 provides detailed guidance on what each section should contain. Your gap analysis should assess compliance at this level of detail, not at the chapter heading level.

Assess Equivalence Claims With Scrutiny

If your legacy device relies on equivalence, this is where the gap analysis becomes critical. MDR Article 61(5) significantly tightened equivalence requirements compared to MDD. Many legacy devices claimed equivalence under MDD based on similar intended use and basic design similarities. That is no longer sufficient.

You must now demonstrate equivalence across technical, biological, and clinical characteristics. You must show that the clinical data from the equivalent device is adequate to demonstrate safety and performance of your device. You must justify any differences and demonstrate they do not affect safety and performance.

In your gap analysis, assess:

Is the equivalent device clearly identified?
If your existing CER refers vaguely to “similar devices on the market” or “class II hemostatic dressings,” the equivalence claim is not sufficiently documented. MDR requires identification of a specific device by name, manufacturer, and basic UDI-DI.

Are technical and biological characteristics compared in detail?
If the equivalence claim is based on general statements like “both devices are made of similar materials,” this will not satisfy reviewers. You need detailed comparison of materials, design, manufacturing, performance specifications, and biological characteristics.

Is there access to clinical data from the equivalent device?
If you claim equivalence but have no access to clinical data or documentation from the equivalent device manufacturer, your claim cannot be substantiated. Equivalence requires demonstration, not assumption.

If your gap analysis reveals that the equivalence claim is weak or undocumented, do not try to patch it. Recognize this as a fundamental gap that will require either generating your own clinical data or conducting a full literature-based evaluation.

State of the Art: The Invisible Gap

One of the most frequently overlooked gaps in legacy device transitions is state of the art analysis. This requirement did not exist under MDD in the same form. MDR Annex I and MDCG 2020-5 make it explicit. You must demonstrate that your device reflects the current state of the art in its category.

State of the art means the developed stage of technical capability at a given time regarding products, processes, and patient management, based on relevant consolidated findings of science, technology, and experience.

Your gap analysis should assess whether your existing clinical evaluation includes:

• A summary of the current state of the art for devices in the same category
• A comparison of your device against that state of the art
• Justification for any deviations or differences
• Evidence that alternative solutions were considered during design

If your existing clinical evaluation does not address state of the art at all, this is a significant gap. It cannot be filled with a single paragraph. It requires research into current clinical practice, current device designs, current safety features, and current performance benchmarks.

PMCF and Post-Market Data Integration

MDR Article 61(11) and Annex XIV Part B require post-market clinical follow-up for most devices. For legacy devices, this creates a dual gap. First, you need a compliant PMCF plan. Second, you need to integrate existing post-market data into your clinical evaluation.

In your gap analysis, assess:

Does a PMCF plan exist?
Most legacy devices under MDD did not have formal PMCF plans. If no plan exists, you are starting from zero. The plan must define methods, data collection procedures, analysis intervals, and triggers for updating the clinical evaluation.

Is post-market data currently collected and analyzed?
Some manufacturers collect complaint data, vigilance data, and return data but never integrate it into clinical evaluation. If this data exists but is not clinically analyzed, you have a process gap, not just a documentation gap.

Is the clinical evaluation updated based on post-market data?
MDR requires periodic updates to the clinical evaluation based on PMCF findings. If your clinical evaluation has not been updated since market entry, this is a compliance gap that must be addressed immediately.

Document the Gaps Honestly

Once you have assessed the clinical evidence foundation, mapped the MDR requirements in detail, and identified where the existing documentation or data falls short, document the gaps clearly.

Do not soften the findings. Do not categorize a fundamental gap as “minor update needed.” If your equivalence claim cannot be substantiated, state that the equivalence approach must be replaced. If your state of the art analysis is missing, state that a full state of the art assessment must be conducted.

This honesty serves two purposes. First, it ensures that your remediation plan is realistic. Second, it demonstrates to the Notified Body that you understand MDR requirements and are approaching the transition with rigor.

Prioritize Remediation Based on Risk

Not all gaps are equal. Some gaps block certification entirely. Others can be addressed through incremental updates or PMCF activities.

Prioritize gaps that affect your ability to demonstrate safety and performance. If your clinical evaluation lacks a valid evidence base, this must be resolved before submission. If your benefit-risk analysis is incomplete or does not consider all relevant risks, this must be corrected immediately.

Gaps related to formatting, structure, or documentation style can be addressed during the final document review. They are important for compliance, but they do not affect the clinical substance.

Your gap analysis should include a remediation plan with timelines, responsibilities, and dependencies. This plan becomes the roadmap for your MDR transition.

Where to Start Tomorrow

If you are beginning a gap analysis for a legacy device, start with the clinical evaluation report. Read it as if you are the Notified Body reviewer. Assess whether it demonstrates safety and performance according to MDR standards, not whether it formally exists.

Then, assess the clinical data foundation. If the device relies on equivalence, validate the equivalence claim against MDR Article 61(5). If it relies on literature, validate the search strategy and appraisal. If it includes clinical investigation data, verify that the data is sufficient and relevant.

Map MDR requirements at component level. Use MDCG 2020-5 and MDCG 2020-6 as your reference. Compare each requirement against what you actually have, not what you think you have.

Document the gaps honestly. Prioritize remediation based on clinical risk and regulatory impact. Build a realistic timeline.

This is not a documentation project. It is a clinical evidence adequacy assessment. Approach it with that rigor, and your gap analysis will serve as a reliable foundation for MDR transition.