[FEATURED] EU Notified Body MDR/IVDR Certificates Data: A Slow-Motion Car Crash
Warnings about lack of notified body capacity to certify products against the EU’s new medtech regulations have become likes waves repeatedly crashing on the shore. With 19 months to go […]
[FEATURED] More Flexible Approach Proposed For EU Notified Body Technical Documentation Reviews
Shortfalls in manufacturer technical documentation submitted to notified bodies cause delays for manufacturers and notified bodies alike. A new document from the notified body association, TEAM-NB, aims to streamline processes.
[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 […]
