Common Specifications: An Antidote To MDR’s Clinical Evidence ‘Moveable Feast’?
Unpredictable clinical evidence expectations under the new EU medtech regulations can have a chilling effect on even the most established companies, resulting in product withdrawals. Medtech Insight asked a regulatory expert how this crisis can be avoided.
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Determining how to provide adequate clinical evidence for CE marking under the EU’s Medical Device Regulation can be a tricky business. But legacy device manufacturers will take comfort knowing they are familiar with some elements of the latest guidance.