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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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?
New designations of notified bodies under the Medical Device Regulation continue to trickle through slowly. The latest brings the EU’s total to 33, still way short of the previous 80 or so under the Medical Devices Directive.