Joint answer given by Ms Bieńkowska on behalf of the European Commission
Written questions: E-002352/19 , P-002465/19

13.9.2019

The Commission acknowledges that meeting the compliance deadlines of May 2020 for medical devices and May 2022 for in-vitro diagnostic medical devices is a challenging task for the whole sector and all concerned stakeholders. The availability of Notified Bodies is one of the most significant issues in this context.

At the same time, the stricter rules foreseen by the new Regulations must be introduced with no further delay, to ensure a higher level of patient safety.

The importance of this has been confirmed in recent discussions in both the European Parliament and the Council. The Commission has been working relentlessly, together with Member States, to ensure that the transition can occur timely and smoothly. In this respect, significant progress has been made.

Up to date, four Notified Bodies have been designated, covering over one third of existing certificates. While progress of the applications depends very much on the level of preparedness of Notified Body applicants, it can be reasonably estimated that a substantially higher number of Notified Bodies will be available before the end of 2019.