EU Roadmap: Finalized Plan For Implementing New Regs Coming Next Month?
A crucial document for industry, the roadmap to the implementation of the EU's new medtech rules, finally seems on the cusp of readiness – four months after the rules entered into force.
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If there is a delay in appointing EU notified bodies under the new Medical Device and IVD Regulations, it will impact the whole sector's ability to comply in time. But nothing is quite ready.
The new EU Medical Device and IVD Regulations will be published any day and take effect within weeks. In this interview, John Brennan, outgoing regulations chief for Medtech Europe, tells Medtech Insight what the European Commission, competent authorities and industry should do now to avoid obstacles.
The revised timelines around products generally used for aesthetic purposes, a small subset of products falling under the Medical Device Regulation, create their own microsphere of complexity.