EUDAMED Goes Mandatory on 28 May 2026 — Is Your Registration Ready?

28 May 2026. Six weeks away.

EUDAMED registration becomes mandatory for medical device and IVD manufacturers placing products on the EU market.

From that date, new devices must be registered in EUDAMED before they can be placed on the EU market. Not after. Before.

Three things manufacturers often underestimate:

The SRN bottleneck. Before you can register a single device, your organisation needs a Single Registration Number. That means actor registration first — and competent authorities are already seeing a surge in submissions.

The AR dependency. Non-EU manufacturers can't complete actor registration without verification from their Authorised Representative. If that relationship isn't properly documented and digitally linked in EUDAMED, you're blocked.

Legacy devices aren't exempt. Devices already on the EU market before 28 May still need to be in EUDAMED by 28 November 2026. That's a lot of portfolio backfilling for manufacturers who've left this late.

One point that often gets missed on Northern Ireland specifically: from 28 May, EUDAMED registration replaces MHRA registration for Northern Ireland market placement. One database, covering both EU and Northern Ireland access.

The clock is running. If your EUDAMED registration isn't already underway, the time to act is now — not in May.

For manufacturers working through a Northern Ireland-based Authorised Representative, EUDAMED actor registration is something we handle as part of the service. One less thing to manage.

Any questions on where to start? Drop them below.

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