How MDR’s Clinical Investigation Rules Could Drive Some Spinal Fusion Products Out Of EU
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?
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Yet another EU regulatory organization has stressed the need for action to address MDR capacity problems. According to CAMD, underlying factors and causes of the crisis must be identified.
Medical devices used in pediatric heart surgeries and other products used for children and for orphan conditions may cease to be available in the EU due to the new Medical Device Regulation compounding existing market pressures, researchers have warned.
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.