Call for feedback concerning revisions to the MDR and the IVDR proposed by the European Commission‍

‍The European Commission has launched a call for feedback concerning the proposed Regulation intended to simplify and reduce the burden imposed by existing rules governing medical devices and in vitro diagnostic medical devices in the EU that was published in mid-December 2025.

Feedback provided so far is as forthright as that related to the Call for Evidence that preceded publication of the proposed Regulation. Many respondents agreed that the procedures imposed by the existing Regulation are complex and demanding and welcome the proposed revisions, although with some reservations and related proposals of their own.

A number of respondents expressed concerns that the reduction in regulatory burden that would result from adoption of the proposed Regulation in its current form would lead to distortion of competition given the investment of time, expertise, and costs that manufacturers launching medical devices onto the EU market on the basis of the current MDR and IVDR have faced.

An opportunity to provide feedback is available until 14 April 2026.