Will Industry Succeed Now In Thrusting Comprehensive Reform Medtech Regulations To Top Of EU Agenda?
It is no secret that there are significant problems in the implementation of the EU’s medtech regulations. But will EU regulators concede to industry’s latest lobbying efforts for fundamental change and accept this challenge as a starting point for discussions?
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The European Commission has conceded to the medtech industry’s calls to delay and modify the new EU regulatory requirements multiple times over the last few years. But will it yield to fresh calls for radical changes being sought by the most powerful lobby yet?
There are 10 listings in the first group of EU reference laboratory to be named. They will not formally assess IVDs for about a year and even then only evaluate products that are in a later batch to comply with the IVD Regulation.
EU Regulatory Roundup, November 2023: Notified Body Advances But Sector Still Demands System Rethink
There is currently a melting pot of ideas concerning the future of the EU’s medtech regulatory system due to its shortfalls. All the while progress is being made, especially in the area notified bodies.