EU Device Coordination Group Offers Eudamed Guidance
Posted 15 April 2019 | By
The EU’s Medical Device Coordination Group (MDCG) on Monday released two new documents explaining how legacy devices can be registered in Eudamed without a unique device identifier (UDI) and how device companies will have until November 2021 to register device data elements in Eudamed.
The two-page document on the registration of data elements explains how the text of the Medical Device Regulation (MDR) presents an inconsistency with regard to what different articles within it say.
But the MDCG clarifies 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)).” That 18-month application date would mean data elements have to be registered by November 2021, or if Eudamed is not functional, May 2022.
The four-page document on the registration of legacy devices, which includes a two-page Annex, explains how Article 120(3) of MDR lacks any specific references to UDI obligations for legacy devices.
Therefore, 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.”
The Annex includes a description of the technical implications and explains basic considerations related to the future registration of legacy devices in Eudamed and technical implementation in Eudamed.
“Legacy devices – covered by a valid Directive certificate - that will continue to be placed on the market after the MDR date of application should be registered in Eudamed without a Basic UDI-DI and UDI-DI. The registration deadlines for those devices is clearly the one referred to in Article 123(3)(e): 18 months after the date of application (provided that Eudamed is fully functional on time),” the Annex says.
However, in case a serious incident or field safety corrective action needs to be reported during the 18 months during which the legacy devices have not yet been registered in Eudamed, MDCG says they must be registered at the moment of the serious incident/field safety corrective action reporting.
Timelines for registration of device data elements in EUDAMED
Registration of legacy devices in EUDAMED