EU MDR

The shortage of notified bodies (NB) in the European Union is a key challenge for device manufacturers struggling with Medical Device Regulation (MDR) compliance. As a result, the EU’s Medical [...]

The global pandemic brought an unexpected change  – FDA remote regulatory assessments (RRA). The FDA wants to expand RRA across all product areas to supplement in-person inspections after it has [...]

Companies marketing devices in the European Union are facing a perfect storm of EU MDR & IVDR regulation challenges. According to a 2022 Medical Device Coordination Group (MDCG) position [...]