The Regulation aims to protect the health and safety of patients and users of medical devices, supply high quality medical devices, support innovation, and create a transparent, robust and sustainable medical device market. The Regulation includes new rules regarding:
· Device classification.
· Stricter oversight of manufacturers by notified bodies.
· The responsible person.
· Unique Device Identifier marking for devices.
· EUDAMED registration.
· Increased post-market surveillance activities.
The Regulation will enter into force on 26 May 2022, except for some provisions which came into force on 26 May 2021.
First published by Practical Law in Jul 02, 2021.