Countdown To 2022 EUEA System As Russia Increases Post-Market Medtech Controls

The sector has been waiting long enough for one of the foundation stones of the implementation of the EU’s Medical Device and IVD Regulations. This month will see a landmark event.

While anticipation grows around the European Commission’s forthcoming medtech proposal, due in mid-December, a series of EU documents have been published on topics including recertification, standards, changes to companion diagnostics and the latest notified body announcements.

The prosthetics market is evolving due to an increase in amputees from war and disease. Unhindr has developed a novel prostetic liner that can reduce the risk of further injury, while Esper is crafting advanced hand implants for Ukraine's front-line soldiers.

The roles and responsibilities of EU medtech’s persons responsible for regulatory compliance vary widely in role and risk exposure. The recent TEAM-PRRC meeting highlighted how vulnerable they can be and the steps to protect themselves.