First Set of EUDAMED Frequently Asked Questions: Deadlines

By Tom Ingless and Evangeline Loh

What is May 28, 2026?

This is the first EUDAMED deadline and marks the end of the 6-month transition period before mandatory use of the first four modules. From this date, all actors who are required to be in EUDAMED (manufacturers (MF), authorized representatives (AR), system and procedure pack (SPP) producers (SP), and importers (IM)) who are actively placing devices on the market, should have a registration in the Actor registration module (ACT) of EUDAMED. In addition, after this date, any MF who wishes to place a device on the market per Article 2 (28) of the MDR (i.e., the first time a device is supplied for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge) or IVD must register said device in the UDI/DEV module before this can occur. Additionally, any notified body that has issued a decision regarding an MDR CE marking certificate must upload it to the notified body and certificates module (NB/CRF). 

What is the SRN and how is it related to ACT?

As part of the ACT module registration process, an entity is issued a Single Registration Number (SRN), which acts as an EU-wide unique identification tool. For MFs not based in the EU, the SRN request is first sent to the AR for verification. The European Competent Authority in which the MF, SP, or AR is based performs the final assessment and approves the SRN request. It is important to note that entities may perform multiple actor roles (e.g., an IM that assembles imported devices into a system as an SP is an IM and SP) and must obtain a unique SRN for each actor role they perform.

What can be determined based on the assigned SRN (primer on the SRN)? 

The first two letters indicate the country in which the actor is based. The second two letters designate the actor’s role (MF, AR, SP, IM). And again, it is one SRN per role. 

What is November 27, 2026?

This is the deadline for devices placed on the market before May 28, 2026 to be registered in the UDI/DEV module. This deadline, of course, applies to all actively marketed legacy devices (compliant to the MDD, IVDD, and AIMDD) benefitting from transition extensions granted.

Where can I get help?

The European Commission has been posting a tremendous number of resources, including a news announcement (June 1). For MFs not based in the EU, the AR (such as Emergo by UL Europe) should also be able to provide guidance. Finally, there are consultancies, such as Emergo by UL, that can assist. 

Concluding remarks

This is part 1 of a series of regulatory updates on EUDAMED FAQs based on questions received during our EUDAMED webinar.