Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 has been published in the European Journal che amends the regulations (EU) 2017/745 and (EU) 2017/746 regarding the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
The Regulation, which enters into force on 21 March 2023, aims to avoid, in the transition phase of medical devices to the new regulatory regime, the failure patient access to a wide range of devices and at the same time to stimulate manufacturers to make every effort to speed up the certification process pursuant to Regulation (EU) 2017/745 for devices already CE marked on the basis of the previous directives.
In particular, the amendment provides for the extension of the validity of the certificates issued pursuant to the directives, provided that certain conditions are met, mainly including the commitment to follow the certification process based on Regulation (EU) 2017/ 745.
Consultation