EU MDR: State of play and challenges to compliance

The European Commission’s Medical Device Regulation, first published in May 2017, became applicable in all European member states in May 2021. New devices will have to meet the requirements of the MDR in order to be placed in the European market. A higher compliance bar under the MDR: the new regulation has created a huge compliance on costs and related processes. A report from Reuters has underlined how medtech companies are stopping to sell in the EU market while doctors’ groups are already reporting medical equipment shortages.

EU leaders have become aware of the problems. The European Commission has recently published the official text of its proposal to amend the transitional provisions for certain medical devices. Key proposals include the exstension of the transition period to the new rules is extended from 26 May 2024 to 31 December 2027 for higher risk devices and until 31 December 2028 for medium and lower risk devices. Medical device manufacturers are well-advised to stay up-to-date on the advancement of the MDR.

In this second edition of this webinar, we aim to sum-up these important updates and all the progress done during these years of the MDR coming into force. Valuable highlights to ensure a smooth transition to the new requirements will be discussed from our expert by helping manufacturers and stakeholders on advanced preparation and early action.