EUDAMED goes mandatory in 2026

For years EUDAMED has sat in the background as a voluntary system. That ends in 2026. From 28 May 2026 the first four modules become mandatory, and for most manufacturers selling into the EU it becomes a condition of staying on the market.

Here is the part that catches people out: EUDAMED is not one switch. Actor registration and your SRN are needed by 28 May 2026, legacy and existing devices must be registered by 28 November 2026, and certificates issued before the deadline have to be uploaded by 28 May 2027. If you wait until the headline date to start, you are already late.

What EUDAMED is, in one paragraph

EUDAMED is the European database for medical devices. It pulls together actor registration, device registration with UDI, certificates, vigilance and post market surveillance into one public and regulatory facing system. The goal is traceability across the whole market. The effect, for you, is that your devices and your role have to be visible and correct in the database.

Who has to act

• Manufacturers placing devices on the EU market.
• Authorised Representatives acting for non EU manufacturers. If you are a foreign manufacturer, your EU AR is the one carrying much of this.
• Importers bringing devices into the EU.

If you sell into the EU from outside it, this is where having your EU Authorised Representative and your registration handled by one team stops being a convenience and starts being a safeguard.

What to do now

1. Confirm who your EU Authorised Representative is and that they are ready to register you as an actor.
2. Get your UDI assignment in order for every device. This is the spine of the whole system.
3. Map your modules to the deadlines so nothing is left until the last phase.

The companies that treat 2026 as a project starting now will move through it calmly. The ones that treat it as a deadline to react to will be doing it under pressure, with a Notified Body queue in front of them.

If you want a clear picture of where your file sits against EUDAMED and the wider transition, a Gap Assessment is the fastest way to get it.