[FEATURED] Calls For More Patient Input In Medical Device Development and Regulation
It is vital to involve patients in medical device development, regulatory assessments, and post-marketing activities. The European Patients’ Academy on Therapeutic Innovation (EUPATI) has explained why and what it is […]
[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 […]
