EU – Commission publishes proposed measures for MDR and IVDR
The EU-commission on 23.01.2024 published several documents detailing proposals with the aim to improve transition to MDR and IVDR and ensure availability of devices. These encompass a press release, a Q&A page, a Factsheet and a proposal for a new Regulation to change MDR and IVDR.
The proposals include an extension of the transition timelines for the IVDR, adaptation to take into account possible device shortages in MDR and IVDR and the possibility to enable the mandatory use of already available EUDAMED modules before obtaining the full availability of all planned EUDAMED modules. In addition the EU will start to evaluate MDR and IVDR with respect to their effects on the availability of devices as well as burdens resulting from them, especially for SMEs.