The new Medical Device Regulation. Impacts, Challenges and Room for Manoeuvre

Millions of people encounter medical devices on a daily basis, often without even realising it. As well as the implants that receive so much coverage in the media, medical devices also include things like dressings, surgical instruments and respirators. The European Union adopted the Medical Device Regulation (MDR) in 2017 with the aim of improving patient safety. Following the conclusion of its transition period, the Regulation will become fully applicable from 26 May 2021.

This acatech IMPULSE discusses the improvements to patient safety promised by the Medical Device Regulation. For example, patient benefits should come about through stricter certification requirements, tougher demands on certification bodies and the introduction of implant registers. The IMPULSE publication also addresses some of the Medical Device Regulation’s problematic impacts on (university) research, as well as for manufacturers and indirectly also for patients, not least in the context of the coronavirus pandemic.