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
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