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.
IVD manufacturers look set to be granted up to 18 more months to comply with the EU IVD Regulation very soon.
Final adoption of EU rules making it mandatory to register in the Eudamed medical device database as of late 2025 now looks like a formality.