[FEATURED] EU MDR: Notified Body Clinical Evidence Expectations Could Spell Trouble for Manufacturers
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 […]
[FEATURED] 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 […]
[FEATURED] Much More Is Needed, Industry Says To EU’s 19-Point Regulatory Action Plan
The new EU Medical Device and IVD Regulations are reaching a critical tipping point. The 19-point plan just released is not going to cut it, medtech players fear. Is this […]