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Guidance document MDCG 2021-13 rev 1 has just been published to include a question on whether medical device and IVD importers into the EU need to register as manufacturers in the Eudamed3 medical device database.

The original version of this guidance document, MDCG 2021-13, which looks at registration requirements for actors other than manufacturers, authorized representatives, and importers in the context of the Medical Device Regulation and IVD Regulation, was published just a few weeks ago.

According to the revised guidance, where an importer assumes the obligations of a manufacturer, for example because it modifies a device/IVD or changes its intended purpose, or puts the product under its own name, it must register as a manufacturer in the Eudamed database.

But if it does not act as a manufacturer because, for example, its activities are not considered to modify a product in a way that could affect its compliance, the importer does not have to register as a manufacturer.

Even where importers of medical devices and IVDs do not have to register as manufacturers, they must still register as importers in Eudamed because they place products on the EU market.

MDCG 2021-13 offered advice on how manufacturers of only legacy products or only “old” products, as well as of custom-made devices and producers of system and procedure packs should register in the new version of the Eudamed medical device database.

When Will Compliance With Eudamed3 Be Mandatory?

Eudamed is currently being upgraded to respond to the needs of supporting the implementation of the MDR and IVDR. The upgraded version is known as Eudamed3.

Compliance with Eudamed3 is currently voluntary. It will not be mandatory until all six of its inter-related modules are ready. The database is due to be officially launched on 26 May 2022, a year after the MDR fully applied and the date of full application of the IVDR. A six-month transition is foreseen for actors to complete the necessary registration.

The procedure to register as an actor in Eudamed will be set out in a Commission Implementing Regulation currently in preparation which will apply to anyone registering in the system.

In the meantime, voluntary registration is encouraged. Indeed, medtech actors have been able to register in the new actor module of Eudamed3 database on a voluntary basis since December 2020.

Clarification about how the various actors, manufacturers, notified bodies and competent authorities should exchange information in the context of the MDR, pending the official launch of the new version of the Eudamed database is also available in the form of a 31-page guidance on harmonized administrative practices and alternative technical solutions (MDCG 2021-1). It includes a 28-page table noting which actors are responsible for what type of information exchange.  (Also see "No Eudamed, No Problem! Latest Guidance Explains Alternatives While Database Is Built" - Medtech Insight, 3 Mar, 2021.)

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