Industry Decries ‘Needle in a Haystack’ Approach to Device Scrutiny Proposal

The European Commission should replace its “random” premarket control mechanism for high-risk medical devices with a systematic procedure that applies to all Class III devices, industry says in a newly released position paper on proposed revisions to the medical device directives. According to Eucomed, the proposed scrutiny procedure is “inappropriate” because it relies on “random sampling” of certain Class III devices “rather than a systematic strengthening of the system for all [C]lass III medical devices.
International Medical Device Regulatory Monitor