EUDAMED becomes mandatory on 28 May 2026: what manufacturers need to do now

On 28 May 2026, EUDAMED — the European Database on Medical Devices — moves from voluntary to mandatory use for the first four functional modules. With less than four weeks remaining, this article sets out what manufacturers, authorised representatives, importers, and system and procedure pack producers need to have in place, including the position for Northern Ireland under the Windsor Framework.

1. The legal trigger

Mandatory use is the consequence of Commission Decision (EU) 2025/2371, published in the Official Journal of the European Union on 27 November 2025. The decision formally confirms that four EUDAMED modules meet the functional specifications required by Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). Under the gradual roll-out provisions introduced by Regulation (EU) 2024/1860, that publication starts a six-month transition period — the clock that ends on 28 May 2026.

There are no extensions on the table. Industry guidance from the Commission, notified bodies, and competent authorities is consistent: economic operators should plan on the assumption that the deadline holds.

2. The four modules going mandatory

From 28 May 2026, the following EUDAMED modules become required:

•       Actor registration — for manufacturers, EU Authorised Representatives, importers, and system and procedure pack producers. Each economic operator needs a Single Registration Number (SRN).

•       UDI/Device registration — for every device placed on the EU market under MDR or IVDR. New devices launched on or after 28 May 2026 must be registered before first placement.

•       Notified Bodies and Certificates — covering the registration of certificates issued, refused, withdrawn, or suspended.

•       Market Surveillance — supporting coordination of inspections, enforcement actions, and non-compliance reports across competent authorities.

The remaining two modules — Post-market surveillance and Vigilance, and Clinical investigations and performance studies — remain pending. Industry expects them to follow a similar gradual roll-out path once the Commission declares them functional, but no decision has yet been published.

3. The deadlines after 28 May 2026

The 28 May 2026 deadline is the headline date, but it is not the only one in the gradual roll-out timeline.

•       28 November 2026 — final deadline for registration of legacy devices, defined as devices placed on the market before 28 May 2026 that will continue to be sold afterwards. This twelve-month window provides time to clean and migrate existing data.

•       28 May 2027 — final deadline for notified bodies to upload information on certificates issued before EUDAMED registration became mandatory. Only the latest version of each certificate and the most recent relevant decision need to be registered.

These secondary deadlines matter for portfolio planning. Manufacturers with significant legacy device populations should treat them as part of the same readiness exercise rather than a separate project.

4. Northern Ireland and the Windsor Framework

Under the Windsor Framework, EU MDR and IVDR continue to apply to medical devices placed on the Northern Ireland market. From 28 May 2026, EUDAMED becomes the mandatory registration route for non-custom-made devices placed on the Northern Ireland market. MHRA registration via the Device Online Registration System (DORS) will no longer be required for those devices for the Northern Ireland market.

Custom-made devices are the exception. They remain outside the scope of EUDAMED and must continue to be registered with MHRA via DORS for placement on the Northern Ireland market.

This is the practical consequence of Northern Ireland’s dual-market position. Devices placed on the Great Britain market continue to be regulated under the UK Medical Devices Regulations 2002 (as amended), with MHRA registration via DORS the relevant route. Devices placed on the Northern Ireland market follow the EU regulatory regime, and from 28 May that means EUDAMED for non-custom-made devices.

Manufacturers operating across both markets — particularly those based in Great Britain or outside the UK and EU — should ensure that their Northern Ireland placements are visible in EUDAMED ahead of the deadline. MHRA guidance confirms that Great Britain-based manufacturers will continue to require an Authorised Representative based in the EU or Northern Ireland in order to place a device on the Northern Ireland market. For non-EU manufacturers, the EU Authorised Representative sits at the centre of the registration chain: AR registration in EUDAMED is one of the prerequisites for the manufacturer’s own device registration to flow correctly.

5. Practical actions before 28 May 2026

Three actions should be in motion now.

1.     Confirm Actor registration and SRN status. If your organisation does not yet hold an SRN, initiate registration immediately. SRNs are not issued instantly, and competent authority validation is required.

2.     Audit the device portfolio against the UDI/Device module. New launches after 28 May 2026 cannot go to market until they are registered. Identify any product launches scheduled for late May or June and ensure their EUDAMED registration is complete in advance.

3.     Confirm Authorised Representative, importer, and system/procedure pack producer registrations. Every economic operator in the supply chain needs to be in EUDAMED. Gaps in any link of the chain create exposure.

A formal readiness assessment, with documented evidence of each step, supports both internal governance and notified body audits.

6. Where EU-UK Authorised Representative Ltd can help

EU-UK Authorised Representative Ltd, based in Northern Ireland under the Windsor Framework, supports medical device manufacturers as EU Authorised Representative, UK Responsible Person, and Person Responsible for Regulatory Compliance (PRRC). Northern Ireland positioning enables a single regulatory base from which to engage both EU and UK regulatory regimes — particularly relevant as the EUDAMED deadline brings the two systems into sharper contrast.

For manufacturers needing AR, UKRP, or PRRC arrangements ahead of the 28 May 2026 deadline, or for support reviewing EUDAMED readiness, contact info@euukrep.com.