Certificates Issued Under EU's Medical Device Regulation Leap By Nearly A Third In Just Three Months
The big question in the EU is whether there is sufficient bandwidth among notified bodies to complete the assessment of all necessary devices under the Medical Device Regulation before their legacy certificates expire. The European Commission is watching the situation carefully.
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The EU’s Medical Device Regulation regulates a small group of products with a mainly aesthetic purpose for the first time. How much notified body capacity will these potentially risky products demand?
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.