EU Parliament Adopts Device Overhaul Proposal, Eases Back on EMA Role

Devicemakers were somewhat upbeat about provisions the European Parliament adopted Tuesday to reform the medtech regulatory framework, but continue to push back against a controversial premarket scrutiny mechanism for high-risk medical technologies. The premarket review was a cornerstone of the proposed text voted out of the Parliament’s health committee in September and would establish a case-by-case centralized premarket authorization regime for high-risk devices managed by the European Commission, the EMA and specified expert groups.
Devices & Diagnostics Letter