The first implementing act under the new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) has been published for consultation and relates to the Notified Body product codes for medical devices and IVDs. Only Notified Bodies that have been designated under the Regulations can carry out conformity assessment procedures, and only for certain types of devices listed in their designation. This draft implementing regulation sets out the list of codes and corresponding types of devices, and is intended to aid clear identification of the expertise of Notified Bodies to perform conformity assessment procedures.
Feedback received so far highlights the fact that a large number of codes may lead to fragmentation of the market, and that the implementing regulation needs to include provisions on how the list can be amended in the future. There are also comments that these codes need to be aligned with other parts of the MDR and IVDR and other product codes already in use, such as GMDN, the Global Medical Device Nomenclature.
The implementing regulation will be published once the feedback is considered by the Committee on Medical Devices within the Commission.