Report on Generating And Assessing Evidence To Optimize MDR And IVDR Due In 2024
Recent meeting at Ernst &Young in Brussels outlines steps ahead and likely timelines for gathering information instrumental in shaping recommendations for the future of the MDR/IVDR and their governance structures.
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Work related to the European Commission’s promise to assess the impact of the Medical Device Regulation, including its impact on innovation, is starting to take shape.
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.