EU MDR Implementation Group Reinforces Historic Clinical Evidence Guidance Document Value
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.
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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.
Detailed guidance documents aim to provide clarity on what constitutes “sufficient” clinical evidence under the new EU Medical Device Regulation. But a void remains between the MDR itself and what notified bodies expect, senior regulatory consultant Søren Underbjerg attests.
The new EU Medical Device Regulation has introduced stricter clinical evidence requirements for many products. But is it even feasible to generate this data for certain legacy devices, such as those used in spinal fusion surgeries, and which products are likely to fall into the high-risk category?