MedTech Europe publishes response to EC proposals for MDR/IVDR revision

MedTech Europe, the European industry association for the medical technology industry, has published its views on the European Commission’s (EC’s) proposals for revision to the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).

The position paper recognises that the EU’s regulatory framework for medical technologies is at a pivotal moment, with significant problems having been identified with implementation of the current regulations. These include: slow and unpredictable conformity assessment timelines, high administrative burdens, and divergent interpretations across Member States. These issues are affecting patient access to technologies, the availability of certain devices, and Europe’s attractiveness for investment.

MedTech Europe generally welcomes the EC’s proposal as a strong basis for reform, identifying the focus on simplification and international cooperation as being particularly important. Moving towards risk-based oversight, streamlining procedures, and advancing digitalisation can reduce unnecessary complexity and allow authorities and notified bodies to focus on what matters most, it concludes.

In addition to publishing its full position paper, the organisation has made available a two-page summary of its comments.