Implementing act on uniform application of the requirements for Notified Bodies (Annex VII)

Posted on 05.02.2026

The draft Implementing Act on Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) Annex VII marks an important and timely step towards reinforcing the practical functioning of the European regulatory framework for medical technologies. By introducing clearer operational provisions and expectations, it contributes to greater predictability, transparency, consistency and reliability in conformity assessment – objectives widely shared across stakeholders.

Over the past year, MedTech Europe and its members have significantly contributed to this process through workshops, structured input and sustained dialogue with regulators and Notified Bodies. These exchanges have been constructive and solution oriented. It is encouraging to see that the draft text is broadly convergent with many of the priorities raised by industry and reflects a growing consensus on the need for a system that works more effectively in practice, not only in principle.

At the same time, some aspects will require further clarification to ensure smooth and consistent implementation. MedTech Europe’s contribution to the consultation on the draft focuses on key additional points that are essential to achieve the intended objectives and support a well-functioning system.

The Implementing Act on Annex VII should be seen as part of a broader package of short-term improvements, fully complementary to the forthcoming targeted revisions of MDR and IVDR. Together, these measures will reinforce confidence in the regulatory framework, support innovation and ultimately improve patient access to safe and effective technologies across Europe.