The European Union (EU) Medical Device Coordination Group (MDCG) have released two new documents outlining how legacy devices can be registered in Eudamed without a unique device identifier (UDI) and how device companies have until November 2021 to register device data elements in Eudamed.
The guidance on the registration of data elements details how the text of the Medical Device Regulation (MDR) presents an inconsistency with regard to what different articles within it say. However the MDCG have clarified that “the obligation for registration in EUDAMED of device data elements listed in both part A, Section 2, and Part B of Annex VI, shall be applicable as from the timelines indicated in Article 123(3)(e) (meaning from 18 months after the general application date or, if EUDAMED is not fully functional on time, from 24 months after the date of publication of the notice referred to in Article 34(3)).” Therefore, the 18-month application date would mean data elements have to be registered by November 2021, or by May 2022 if Eudamed is not functional.
The guidance on the registration of legacy devices explains how Article 120(3) of MDR lacks specific references to UDI obligations for legacy devices. The MDCG “considers it appropriate to adapt the Eudamed design to allow the registration of legacy devices in Eudamed in the absence of a (Basic) UDI-DI. This is intended to prevent any technical constraint to the applicability of Art 120(3) for legacy device registration in Eudamed.”
It is important to note that in case a serious incident or field safety corrective action needs to be reported during the 18 months in which the legacy devices have not yet been registered in Eudamed, the MDCG have stated that they must be registered at the moment of the serious incident/field safety corrective action reporting.
To read the MDCG guidance on timelines for registration of device data elements in Eudamed, please click here.
To read the MDCG guidance on registration of legacy devices in Eudamed, please click here.