EUDAMED explained: registration, the database and the 2026 deadlines

EUDAMED, the European Database on Medical Devices, is mandatory now. Four of its six modules have been compulsory for medical devices and in vitro diagnostic devices on the EU market since 28 May 2026, and any device first placed on the market since that date had to be registered before its first unit was placed. The next hard date is November 2026, when devices that were already on the market must be registered too. We work through what the EUDAMED database is, the legal decision that switched it on, actor registration and the Single Registration Number (SRN), device registration and the legacy device rules, certificates, the vigilance module, Northern Ireland, the public site, and the mistakes we see most.

What is EUDAMED?

The EUDAMED database is the EU’s central database for devices regulated under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). It has six modules:

1. Actor registration
2. Unique Device Identification (UDI) and device registration
3. Notified Bodies and certificates
4. Market surveillance
5. Post market surveillance and vigilance
6. Clinical investigations and performance studies

Regulation (EU) 2024/1860 set how it goes live, one module at a time. Under the amended rules, each module becomes mandatory six months after a notice in the Official Journal of the European Union confirms that it works. Until a module is mandatory, the old national rules based on the directives apply to whatever it covers.

Is EUDAMED mandatory in 2026?

Yes, and it has been since 28 May 2026. There is no ambiguity left.

Commission Decision (EU) 2025/2371 of 26 November 2025 declared the first four modules functional: actor registration, UDI and device registration, Notified Bodies and certificates, and market surveillance. The notice was published in the Official Journal on 27 November 2025. Six months later, on 28 May 2026, those four modules became mandatory.

The two remaining modules, vigilance and clinical investigations, are not yet mandatory. Everything else in this guide flows from those two facts.

Date	What happens	Status on 25 September 2026
December 2020	Actor registration opens	Open
26 November 2025	Decision (EU) 2025/2371 declares four modules functional	Done
27 November 2025	Notice published in the Official Journal	Done
28 May 2026	Four modules mandatory. New devices registered before the first unit is placed	In force
28 November 2026	Devices already on the market before 28 May 2026 must be registered (planning date, see below)	Due
Fourth quarter of 2026	Planned notice for the vigilance module	Provisional
Second quarter of 2027	Planned mandatory use of the vigilance module	Provisional
28 May 2027	Notified Bodies complete upload of existing certificates	Upcoming

What is an SRN and how do I get one?

The SRN is the Single Registration Number EUDAMED issues when an actor registers. Manufacturers, importers and authorised representatives must register in the Actor module and obtain an SRN before placing a device on the market. That applies to manufacturers outside the EU as well as inside it. Actor registration has been open since December 2020, so for most established companies this first step of EUDAMED registration should already be done.

Some actors get an Actor ID instead of an SRN. Producers of systems and procedure packs, and manufacturers that only make custom made devices, are in that group. Distributors do not register in EUDAMED at all, although national registration may still apply to them. For other actor types, the Medical Device Coordination Group (MDCG) guidance is MDCG 2021-13 rev.1.

If you are outside the EU, your authorised representative registers as an actor in its own right and has registration duties under Article 11 of the MDR. Our guide to the EU Authorised Representative under Article 11 explains how that mandate works. Registering your devices, though, stays your job as the manufacturer.

What is the deadline to register existing devices in EUDAMED?

It depends on when the device was first placed on the market.

Devices first placed on the market from 28 May 2026 must be registered in the UDI and device module before the first unit is placed. Registration is per UDI-DI, the device identifier part of the UDI, or per EUDAMED ID for a legacy device.

Devices first placed on the market before 28 May 2026, and still being placed after it, must be registered within 12 months of the notice’s publication under Article 123(3)(e) of the MDR. This applies to legacy devices and regulation devices alike.

Here is the detail that matters. The Commission’s own worked example of the method takes a notice published on 1 July 2025, gives mandatory use from 2 January 2026, and a registration deadline of 2 July 2026. Apply the same method to a notice published on 27 November 2025 and the deadline comes out as 28 November 2026, which is the date the Commission’s own transition timeline gives: 28 November 2026 is the deadline to register the device in the UDI and device module. Our advice is simply not to leave it to the last week.

For a portfolio of any size this is not a weekend job. Each UDI-DI needs its data, and each record needs checking. If you have not started, start now.

Do legacy devices need to be registered in EUDAMED?

Usually yes, with two exceptions. A legacy device does not need to be registered if “the same device”, meaning the same UDI-DI, catalogue number or trade name, is already registered as a regulation device, one placed on the market under the MDR or IVDR. It also does not need registering if no more units are placed on the market after 28 May 2026. In both cases a later vigilance action can still require registration.

Custom made devices cannot be registered in the UDI and device module at all.

Remember what legacy status does and does not do. It delays conformity assessment against the regulation. It does not delay registration, post market surveillance or vigilance. Our guide to moving legacy devices from the Medical Device Directive to the MDR sets out who qualifies as a legacy device.

What comes next: certificates and the vigilance module

Certificates. Notified Bodies must upload existing MDR and IVDR certificates within 18 months of the notice under Article 123(3)(ea) of the MDR, which by the same method is 28 May 2027. New certificates issued after 28 May 2026 go straight into EUDAMED. The obligation to upload the summary of safety and clinical performance (SSCP) starts when the certificate is registered. MDCG 2026-4 (June 2026) is the position paper on managing these summaries, written SS(C)P to cover devices and in vitro diagnostics, in EUDAMED now that use is mandatory.

Vigilance. The post market surveillance and vigilance module is not available for voluntary use. The Commission’s timeline from November 2025 shows an audit of a minimum viable version, a notice planned for the fourth quarter of 2026 and mandatory use planned for the second quarter of 2027. It also says the timeline “might be updated depending on the audit results”. Treat those dates as provisional. Until then, vigilance reporting runs through national processes, with MDCG 2021-1 rev.1 and MDCG 2022-12 as the guidance. Our explainer on what MDCG guidance documents are covers how much weight they carry. Periodic safety update reports for Class III and implantable devices move to EUDAMED only when this module is mandatory.

Clinical investigations and performance studies. This module is still in analysis and development and has no date on the Commission timeline. Once its notice is published, coordinated assessment becomes mandatory five years later.

Northern Ireland and the public EUDAMED site

Northern Ireland is covered too. Since 28 May 2026, devices placed on the Northern Ireland market, other than custom made devices, must be registered on EUDAMED.

The EUDAMED public database is at ec.europa.eu/tools/eudamed, and the Commission runs an EUDAMED information centre for users. Check your own records there once they are registered.

EUDAMED mistakes we see

• “EUDAMED is still voluntary.” Four modules have been mandatory since 28 May 2026. November 2026 is not the start date. It is the registration deadline for devices already on the market.
• “My Notified Body or authorised representative will register my devices.” The manufacturer registers its devices. The Notified Body uploads certificates. The authorised representative has its own actor registration.
• “Vigilance reports now go through EUDAMED.” Not until the vigilance module is declared functional and becomes mandatory, currently planned for the second quarter of 2027.
• “All legacy devices must be registered.” Not if the same device is already registered as a regulation device, or if no more units are placed after 28 May 2026.
• “The November deadline is weeks away, so it can wait.” Registration takes longer than people expect, because the data behind it has to be right. Start now.

For the wider picture of the regulation EUDAMED serves, see our EU MDR guide and our IVDR guide.

Where Worldwide Device Solutions fits

For manufacturers outside the EU, EUDAMED is where your authorised representative’s work becomes visible. We act as EU Authorised Representative from Cork and UK Responsible Person from Newcastle upon Tyne, on one contract, so your EU registrations and your UK obligations are handled by the same team.

If you are not sure whether your actor registration, your device records or your legacy devices are in order before November, book a free consultation. If you want the full picture across your file, our fixed fee Gap Assessment puts it in writing.