Real-time surveillance monitoring official releases, recall notifications, safety alerts, and guidance publications from US FDA (CDRH), CDSCO India, European Commission (EU MDR/IVDR MDCG), and MDSAP.
10
Total Notices
Industry asks FDA to expand prior knowledge guidance RAPS
FDA finalizes recall due to heart devices sending delayed alerts—software update on the way Cardiovascular Business
Recall Roundup: August 2026 Healthcare Brew
Euro Roundup: Committee warns ‘overly expansive’ MDR interpretation could undermine access to cell and tissue products RAPS
EU Rethinks How to Regulate AI in Medical Devices – Interplay between the MDR and AIA under current and proposed legislation Hogan Lovells Cadwalader
European Commission expands list of well-established technologies under MDR RAPS
This Viral Medical Device Has Everyone Confused Because It Looks Wildly Inappropriate BuzzFeed
Boston Scientific’s SCS leads linked to 1,081 serious injuries in FDA alert Medical Device Network
FDA rallies HRT manufacturers amid US-wide estradiol patch shortage Medical Device Network
MDR and IVDR revision should mean much-needed simplification – but it must go further Med-Tech Insights
Automated regulatory surveillance engine aggregating official notices, guidances, and safety advisories across US FDA, CDSCO, European Commission, and Notified Body channels.
