The UK Government is running a targeted consultation on the possible indefinite recognition of CE‑marked medical devices on the Great Britain market. This initiative is…
Notified Bodies survey on MDR/IVDR certifications and applications
The European Commission has released updated data from the survey conducted among Notified Bodies on certifications and applications under the Medical Devices Regulation (MDR) and…
US and EU regulatory systems for medical devices in comparison
Switzerland relies significantly on imported medical devices. With the implementation of the EU Medical Devices Regulation (MDR) and a mutual recognition agreement (MRA) terminated in…