Clinical Evaluation Updates: When MDR Says Now, Not Later
I reviewed a clinical evaluation report last month that was three years old. The device was still on the market. The manufacturer believed they were compliant because they had a PMCF plan in place. The Notified Body disagreed. The issue was not the plan. The issue was that no one had updated the clinical evaluation itself.
This happens more often than it should. Manufacturers confuse having a PMCF plan with maintaining a clinical evaluation. They treat the clinical evaluation report as a static document—something you write once for certification and revisit only when something major changes.
But under MDR, the clinical evaluation is not a document. It is a process. And that process requires continuous activity. The question is not whether you need to update it. The question is when and how often.
What the Regulation Actually Says
MDR Article 61(11) is clear. Manufacturers must update the clinical evaluation throughout the lifecycle of the device. It must be part of the post-market surveillance and the post-market clinical follow-up. Annex XIV, Part A, reinforces this: the clinical evaluation must be updated with data from PMCF and with relevant new scientific literature.
The regulation does not set a rigid schedule. It does not say
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
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