EU Commission publishes Legislative Proposal to Extend the MDR Transitional Provisions
Posted on 02.02.2023
Following the December 2022 EPSCO meeting, the European Commission published on 6 January 2023 their proposal to extend the Medical Devices Regulation (MDR) transitional period. MedTech Europe welcomes the Commission’s recognition of the ongoing urgent risks of medical device shortages in Europe.
It is now of utmost importance that the European Parliament and Council adopt this legislative proposal as swiftly as possible to restore an acceptable regulatory pathway that enables all categories of medical devices to remain available to patients and healthcare systems.
Of note: while the proposal mainly amends the MDR Regulation, it also amends a piece of the IVDR transitional provisions, i.e., the “sell-off’ provision.
At the same time, MedTech Europe will continue to actively follow the work undertaken in regards to non-legislative measures published earlier last year, see e.g. MDCG 2022-14 and MDCG 2022-18.
For more information, please contact Merlin Rietschel, Senior Manager Medical Devices.