The EU Commission’s proposal COM (2025) 1023 final – widely referred to within the medical device industry as MDR 2.0, aims to simplify the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).

The draft was published by the Commission on 16 December 2025 and has been submitted to the European Parliament and the Council under the ordinary legislative procedure for adoption.

For clinical teams, the proposed changes mean efficiency gains via reduced administrative tasks, fewer clinical investigations and technical documentation assessments for WET devices, and ultimately, reduced regulatory burden and accelerated market access.

In our 5-minute guide below, our Head of Clinical Dr. Sarah Bosshard shares an overview of three major proposed changes in MDR 2.0 that will affect clinical activities. Read in the viewer or download at the button – and should you have a clinical challenge related to your medical device, get in touch with our experts.