Regulation (EU) 2017/745 on medical devices (MDR) is not even three months away and the designation of Notified Bodies is still behind the expectations of the industry and the announcements made by the European Commission.
The last body that has been designated under the MDR is the National Standards Authority of Ireland (NSAI). Manufacturers may now choose between 11 organizations.
Under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), still only three bodies have been designated so far.
Source: NANDO database