Eudamed actor registration module set to launch in December
In a position paper released Tuesday, the European Commission’s Medical Device Coordination Group (MDCG) confirmed that the Eudamed actor registration module will be deployed on 1 December 2020.The module was previously expected in May, but its deployment was pushed back by the Commission just before its launch date to reflect the postponed date of application of Eudamed. At the time, the Commission said it would pursue a phased rollout of the six Eudamed modules prior to the May 2022 date of application. (RELATED: Eudamed to launch in 2022 for both devices and IVDs, Regulatory Focus 30 October 2019; EC sets timeline for rolling out Eudamed modules, Regulatory Focus 14 May 2020).
MDCG explains that the actor registration module is a “prerequisite” for accessing Eudamed and using its other modules and “strongly encourage[s] the use of the actor registration module by all relevant actors on their territories, including the use of the single registration number [SRN] by actors as stipulated in the [Medical Device Regulation] MDR.”
MDCG also clarifies that “double registration requirements for actors should be avoided as much as possible,” and says that actors, including manufacturers, authorized representatives, importers and system/procedure pack producers, who have obtained an SNR should be considered in compliance with actor registration requirements.
Gert Bos, PhD, FRAPS, executive director and partner at Qserve, said the position paper is an “encouraging sign” that the phased deployment of Eudamed modules is moving forward.
Bos also said the position paper takes a practical approach to avoid multiple registrations, explaining that, “A legal entity might have multiple roles for the same or different products … to avoid double or triple registration, the guidance suggests to register once and get an SRN, but comply with the legal requirements of all the roles the company has under MDR or [In Vitro Diagnostic Regulation] IVDR.”