The European Commission has updated its figures on the status of readiness of notified bodies under the Medical Device and IVD Regulations. Three more designations are imminent, but just one under the IVDR.
The urgency of having the necessary structures in place, including notified bodies, so that manufacturers can comply with the IVD Regulation, continues to be emphasized by all stakeholders in the EU IVD sector.
Accompanying this is a general sense that there has been a lack of transparency about when additional designations will be made, which hinders companies’ preparations.
The latest figures from the European Commission show that progress is being made, but not as quickly as the sector would like.
