Innovation To Suffer Under Revised MDR Unless Addressed Now, Suggest MDR Proposal Responses
Executive Summary
Damage to SMEs and innovation, overly high notified body costs and concerns over lack of surveillance for critical devices are all topics addressed among responses to the European Commission’s latest MDR proposal.
You may also be interested in...
Moves For Go Ahead For MDR Proposal To Be Discussed At European Parliament
The European Commission’s proposal to extend transition timelines for legacy devices in the context of the Medical Device Regulation is already on the move. There are still questions, however, about whether a fast-track adoption is in the best interests of the medtech sector.
EU Regulatory Experts Support Notified Bodies, But Argue For Greater Consistency
Notified bodies have been a pivotal part of the EU medtech regulatory system since it was first launched in the 1990s. Where might they fit within a new medtech regulatory governance structure? Panelists on a recent vodcast grappled with the question.
First Public Discussion On How EU Medtech Regulatory Governance Structure May Evolve
Does the EU need a medtech agency for the first time in its history? Nothing can or should be decided too quickly but five high-profile experts broadly agreed that change is now critical.