Why Your 2015 CER Will Fail MDR Review
Last month, I reviewed a Clinical Evaluation Report dated 2015 that a manufacturer submitted for MDR certification. The technical file looked organized. The CER had 150 pages. The literature review covered 40 studies. But within the first 15 pages, I counted eight structural deficiencies that would trigger immediate rejection by a Notified Body. The manufacturer believed a simple update would suffice.
In This Article
It will not.
This is not about adding a few pages or updating the PMCF section. The gap between what was acceptable under the Medical Device Directive and what is now required under MDR is not incremental. It is fundamental.
And most manufacturers discover this only after their first major review.
The MDD Framework Was Never Designed for Clinical Scrutiny
Under MDD, a Clinical Evaluation Report was often treated as a compliance document. The goal was to demonstrate sufficient clinical evidence to support CE marking. The bar was lower. The process was less defined. The scope was narrower.
Many CERs from that era reflect this approach. They were written to check a box, not to withstand clinical challenge.
MDR changed the entire logic. Article 61 of MDR 2017/745 requires manufacturers to demonstrate clinical safety and performance through a continuous process of clinical evaluation. MDCG 2020-6 provides the detailed methodology. MDCG 2021-25 adds further clarification on what constitutes sufficient clinical evidence.
The shift is not just regulatory. It is epistemological.
MDD allowed for a static justification. MDR requires a dynamic, evidence-based clinical case that evolves with your device lifecycle and medical knowledge.
What Made Sense in 2015 Is Now a Deficiency
When I compare legacy CERs to current MDR submissions, the structural gaps are consistent. These are not edge cases. These are patterns I see across multiple projects and multiple device categories.
The Literature Search Was Too Narrow
Most 2015 CERs used a simplified literature search. A few keywords. A few databases. A cutoff date. No systematic protocol. No documentation of the search strategy. No explanation of inclusion and exclusion criteria.
MDCG 2020-6 now requires a systematic, transparent, and reproducible literature search. You must define your PICO framework. You must document every search string. You must justify every exclusion.
A legacy CER that states “we searched PubMed for X and found Y studies” will not survive review. The reviewer will ask: What about Embase? What about Cochrane? What was your search strategy? How did you manage duplicates? Why did you exclude Z?
You cannot answer these questions retroactively.
Equivalence Claims Were Loosely Defined
Under MDD, equivalence was often claimed with minimal justification. “Our device is similar to Device X, which has been on the market for years.” That was sometimes enough.
Under MDR, equivalence requires rigorous demonstration across technical, biological, and clinical characteristics. MDCG 2020-5 defines the criteria. The Notified Body will scrutinize every aspect.
If your 2015 CER relies on equivalence but does not provide a detailed comparison, you do not have a compliant equivalence claim. You have an unsupported assertion.
Legacy CERs claim equivalence without providing side-by-side technical specifications, biological evaluation data, or clinical outcome comparisons. This is now an automatic rejection point.
The Risk Analysis Was Not Integrated
Many older CERs treated clinical evaluation and risk management as separate exercises. The CER would reference the risk analysis but would not integrate it into the clinical reasoning.
MDCG 2020-6 requires that the CER explicitly addresses identified risks and demonstrates how clinical data confirms acceptability of the residual risk. Every risk in ISO 14971 must have a corresponding clinical justification in the CER.
If your 2015 CER mentions risks only in passing, you do not have integration. You have two disconnected documents.
The State of the Art Was Frozen in Time
A CER from 2015 reflects the state of medical knowledge in 2015. But the State of the Art is not static. New studies emerge. New devices enter the market. New treatment guidelines are published. New safety signals appear.
MDCG 2020-6 requires that the CER reflects current medical knowledge and current clinical practice. A SOTA section from 2015 is outdated by definition.
The Notified Body will ask: What has changed since 2015? What new evidence exists? How does your device compare to current alternatives? Why is this SOTA section still valid?
You cannot defend a frozen SOTA.
The PMCF Gap
This is where the structural incompatibility becomes most visible. Under MDD, post-market surveillance was often reactive and minimal. The clinical evaluation was typically front-loaded. Once the device was on the market, clinical follow-up was limited.
MDR requires a proactive, structured, and continuous PMCF process. MDCG 2021-25 provides the methodology. The CER must include a PMCF plan that addresses specific clinical questions, defines data collection methods, and commits to timelines.
Most 2015 CERs do not have a PMCF plan at all. Or they have a generic statement like “we will monitor complaints and vigilance reports.”
That is not a PMCF plan. That is basic post-market surveillance.
The Notified Body will reject this immediately. They will ask: What specific clinical questions remain unanswered? How will you collect real-world data? What are your endpoints? When will you update the CER?
Without a compliant PMCF plan, you cannot close the clinical evaluation loop. And without closing the loop, you cannot maintain MDR compliance.
PMCF is not an add-on. It is the mechanism that keeps your clinical evaluation alive. A legacy CER without a robust PMCF plan cannot be updated—it must be rewritten.
The Review Process Will Expose These Gaps
When a Notified Body reviews your legacy CER, they do not start with the assumption that it is acceptable and needs minor updates. They start with the MDR checklist.
They check: Is the literature search systematic and documented? Is the equivalence claim justified? Is the risk analysis integrated? Is the SOTA current? Is the PMCF plan defined?
If the answer to any of these is no, you receive a major non-conformity. And major non-conformities cannot be resolved with addendums or supplementary documents. They require structural correction.
I have seen manufacturers submit 50-page gap analysis documents trying to retrofit a 2015 CER into MDR compliance. It does not work. The foundation is wrong. The methodology is wrong. The structure is wrong.
You cannot patch a document that was written under a different regulatory logic.
What Actually Needs to Happen
The only viable path for a legacy device is to rewrite the CER from the ground up using the MDR methodology.
This means conducting a new, systematic literature search with a documented protocol. This means building or rebuilding your equivalence demonstration with full technical, biological, and clinical justification. This means integrating the risk analysis into every clinical conclusion. This means updating the SOTA to reflect current knowledge. This means developing a real PMCF plan with specific objectives and timelines.
This is not an update. This is a new clinical evaluation.
The technical data may be reusable. The clinical studies you cited may still be relevant. But the document itself must be rebuilt according to MDR structure and logic.
Manufacturers who accept this early save months of back-and-forth with Notified Bodies. Manufacturers who resist this reality face repeated rejections until they eventually arrive at the same conclusion.
Manufacturers submit a 2015 CER with a 2024 addendum. The addendum addresses PMCF. But the core CER still reflects MDD logic. The Notified Body rejects both documents because the foundation is non-compliant.
The Timeline Consequence
Rewriting a CER takes time. A typical MDR-compliant CER for a Class III device requires 3 to 6 months of focused work, depending on complexity and data availability.
If you are in the middle of MDR transition and you discover that your legacy CER is not viable, you are now facing a significant delay. This delay affects your certification timeline. It affects your market access. It affects your business planning.
This is why the gap assessment must happen early. Before submission. Before contracting with a Notified Body. Before committing to a timeline.
If you wait until the Notified Body tells you the CER is not acceptable, you are already behind.
Final Thought
A Clinical Evaluation Report from 2015 was compliant under MDD. It served its purpose. But MDR is not MDD with additional requirements. It is a different framework with a different clinical standard.
Your legacy CER will not survive MDR review because it was never designed to. And trying to force it into compliance through addendums and gap analyses wastes time, resources, and credibility with your Notified Body.
The manufacturers who transition successfully are the ones who accept this reality early and commit to doing the clinical evaluation work that MDR actually requires.
The others keep trying to salvage documents that cannot be salvaged.
You decide which path makes sense.
Peace,
Hatem
Clinical Evaluation Expert for Medical Devices
Follow me for more insights and practical advice.
Frequently Asked Questions
What is a Clinical Evaluation Report (CER)?
A CER is a mandatory document under MDR 2017/745 that demonstrates the safety and performance of a medical device through systematic analysis of clinical data. It must be updated throughout the device lifecycle based on PMCF findings.
How often should the CER be updated?
The CER should be updated whenever significant new clinical data becomes available, after PMCF activities, when there are changes to the device or intended purpose, and at minimum during annual reviews as part of post-market surveillance.
What causes CER rejection by Notified Bodies?
Common reasons include inadequate equivalence demonstration, insufficient clinical data for claims, poorly structured SOTA analysis, missing gap analysis, and lack of clear benefit-risk determination. Structure and logical flow are as important as the data itself.
Which MDCG guidance documents are most relevant for clinical evaluation?
Key documents include MDCG 2020-5 (Equivalence), MDCG 2020-6 (Sufficient Clinical Evidence), MDCG 2020-13 (CEAR Template), MDCG 2020-7 (PMCF Plan), and MDCG 2020-8 (PMCF Evaluation Report). MDCG 2020-6, MDCG 2021-25
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Peace, Hatem
Your Clinical Evaluation Partner
Follow me for more insights and practical advice.
– MDR 2017/745 Article 61
– MDCG 2020-6: Clinical Evaluation Framework
– MDCG 2021-25: PMCF Plan Template and Evaluation
Related Resources
Read our complete guide to CER under EU MDR: Clinical Evaluation Report (CER) under EU MDR
Or explore Complete Guide to Clinical Evaluation under EU MDR
