Member States Want Action Over High-Risk IVDs And Eudamed Medical Device Database
After some 10 years of the implementation of the EU’s Medical Device and IVD Regulations being an annual agenda item at December Council of the EU meetings, the scale of problems remains the same.
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Despite protests from the European Commission that it would not extend the IVDR transition periods any further and could not launch the Eudamed database until all modules were ready, these things and more are due to happen, and soon.
Lack of predictability uncertainty over fees and inefficient working practices inherent in the current implementation of EU rules are all demanding a rethink in the EU’s current and future medtech rules. Industry expects discussions to kick off early next year.
With the deadline for class D high-risk IVDs less than 18 months away and the underpinning regulatory structure still embryonic, MedTech Europe calls for clearer policies to give manufacturers a good chance of overcoming the regulatory challenges in time.