What are examples of inadequate PMCF data resulting in audit findings in MDD or MDR audits?

We have seen the gamut from lower risk to higher risk devices needing PMCF. For example, we had a pretty well-established Class IIa device that had limited clinical data that was not high quality. They used equivalence and then got a finding asking them to prove they had sufficient clinical evidence for initial conformity based on the studies they did have.

 

 

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