First set of IVDR/MDR Implementing acts on the horizon

As the first deadlines arising from the texts of the IVD Regulation (EU) 2017/746 and MD Regulation (EU) 2017/745 are approaching, the Commission is determinedly working on the first set of implementing acts to start putting in place the governance and the structure of the new Regulations. While no draft implementing acts are available yet, once they are ready they will be made available for public consultation through the feedback mechanism on this website. Stakeholders and citizens are able to provide feedback during a 4-week public consultation on draft delegated and implementing acts (certain exceptions apply - see 4.1; also note that stakeholders are consulted as part of the Commission’s better regulation package).

We can expect that the first set of the upcoming implementing acts will be dedicated to the designation and application for Notified Bodies. The Notified Body Operations Group (NBOG) gathering designating National Authorities responsible for the control of notified bodies acting in the area of medical devices, has released its draft list of codes and corresponding types of devices for the purpose of specifying the scope of the designation of notified bodies under the IVD Regulation (EU) 2017/746 and under the MD Regulation (EU) 2017/745 in August. At the same time, the draft list of documents to be submitted in the application for designation as a notified body under both Regulations was also published.

These documents provide a good insight into the regulators’ intention and are expected to form a key part of implementing acts on notified body designation and application. Once ready, they will be made available for consultation in some weeks. The ultimate deadline for publishing these first implementing acts into EU law is 26 November 2017.