Articles tagged with: Deadlines and exemptions

While waiting for Eudamed, registration in the Ministry's database remains mandatory. This includes devices under MDR.

The difference between placing on the market and making available, to clearly define when to adapt devices to MDR.

The unique, publicly accessible database providing an up-to-date picture of the lifecycle of medical devices in Europe.

The Medical Device Regulation (MDR) establishes the new European rules for conformity assessment. The key steps.

Manufacturers, authorized representatives, system and procedure pack producers, and importers must register in Eudamed's Actor registration module.

The European Commission proposes postponing the medical device regulation. The content of the proposal and the new dates.

New compliance dates for reusable surgical instruments in the latest amendment to the medical device regulation.