CER Rejection: How to Appeal Without Starting Over
Your Clinical Evaluation Report came back with a 28-page deficiency list. The Notified Body says your literature search is not systematic, your equivalence demonstration is insufficient, and your benefit-risk profile lacks quantification. Your first instinct is to rewrite everything. But before you do, you need to understand what the reviewer actually expects and what can be fixed without rebuilding the entire report.
I have reviewed appeal responses that succeeded and those that failed. The difference is rarely about the quality of the device or the clinical data. It is about understanding what the Notified Body found unclear, incomplete, or non-compliant, and then responding with precision.
Most manufacturers approach a CER rejection as a catastrophic failure. They panic, they scramble, and they rewrite sections that were actually acceptable. This wastes time and often introduces new deficiencies.
The reality is simpler. Most CER rejections are about structure, traceability, and completeness. Not about the device itself.
Understanding What Rejection Actually Means
A CER rejection does not mean your device is unsafe or that your clinical data is worthless. It means the Notified Body could not verify compliance based on what was presented in the report.
Under MDR Article 61 and Annex XIV, the CER must demonstrate sufficient clinical evidence to support the safety and performance claims of the device. When a Notified Body rejects a CER, they are saying: we cannot confirm this based on what you have shown us.
This is a critical distinction. The problem is often not the evidence itself. It is how the evidence was presented, linked, and justified.
A rejection is not a verdict on your device. It is a gap in your demonstration. The gap can be in your data, your reasoning, or your documentation. Identify which one before you respond.
Why CERs Get Rejected
There are five recurring reasons I see in rejected CERs. Each one reflects a misunderstanding of what the Notified Body needs to verify.
1. Literature Search Is Not Systematic or Transparent
MDCG 2020-13 requires a systematic literature review with defined search strings, databases, inclusion and exclusion criteria, and a PRISMA flow diagram. If any of these elements is missing or unclear, the reviewer cannot verify that you identified all relevant clinical data.
I have seen CERs where the manufacturer states they reviewed
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).
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Peace, Hatem
Your Clinical Evaluation Partner
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