On the 26th of May 2021, the new Medical Devices Regulation (EU) 2017/745 (MDR) came into effect. Medical devices placed on the EU market must now comply with the MDR. After the transitional period and a delay due to the COVID-19 emergency, this is an important date for manufacturers and their authorized representatives, as well as importers and distributors of medical devices.
The full MDR text is available here.
The European Commission provides more details:
- An overview of the regulatory framework for medical devices
- Factsheet for Authorised Representatives, Importers and Distributors of medical devices and in vitro diagnostic medical devices
- Information on Unique Device Identifier
The new Regulation is fully effective for the devices considered by the registries that make part of RIPI: joint prostheses, spinal implants, pacemakers, defibrillators, and heart valves.
For further information, see the article “A far-reaching Regulation for the Italian National Registry of Implantable Prostheses: a possible model for other health registries” by Virgilia Toccaceli and Marina Torre, recently published in the Annali dell’Istituto Superiore di Sanità.