MedTech Europe’s Response to the European Commission’s Proposal for amending the Medical Devices Regulation

Posted on 06.01.2023

MedTech Europe takes note of the recent publication of the European Commission’s proposal to amend the transitional measures in the Medical Devices Regulation (EU) 2017/745 and will assess it in the coming days.

The medical devices industry welcomes the Commission’s recognition of the ongoing urgent risks of medical device shortages in Europe, stemming from the Medical Devices Regulation implementation challenges.

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.

MedTech Europe members remain committed to complying with the Medical Devices Regulation. MedTech Europe will continue to work with EU stakeholders and decision makers to ensure the successful implementation of this Regulation.