EUDAMED registration mandatory as of 28 May: no entry to the EU market without an SRN

From 28 May 2026, use of four EUDAMED modules becomes mandatory under the MDR and IVDR: actor registration, UDI/device, notified bodies and certificates, and market surveillance. Previously the system was voluntary and many manufacturers had deferred registration.

The modules being mandatory together creates a sequential dependency: data cannot be entered into the other modules until actor registration is complete. The critical path of the timetable is therefore approval of actor registration, not UDI data.

Actor registration results in a verified Single Registration Number (SRN). The number is verified by the relevant competent authority; so the process does not end when the manufacturer fills in a form, but when the authority approves it.

Without a valid SRN it is not legally possible to place the device on the EU market. The unpredictability of approval time means a direct shipping risk for a manufacturer who leaves registration to the final week.

For manufacturers entering the market via an authorised representative, the registration chain is two-sided: the representative must also have its registration and verified number. One side being incomplete renders the other's data unusable too.

The rule is clearest for new devices: from 28 May 2026, new devices under the MDR/IVDR must be registered in EUDAMED before being placed on the market.

For devices already placed on the market before 28 May 2026, the deadline is 28 November 2026. This means the entire existing portfolio must be entered into the system within six months — the real burden here for manufacturers with a large number of items.

The deadline for uploading certificates issued before 28 May 2026 into the system is 28 May 2027. Because this requires coordination with the notified body, it should be planned rather than left to happen by waiting.

EUDAMED is not an archive but a live record through which market surveillance operates. An inconsistency in device data — such as the UDI on the label not matching the record in the system — can turn directly into a non-conformity finding.

Treating registration as data entry disconnected from the technical documentation therefore proves expensive later. Every field entered into the system must match its counterpart in the technical file.

One of the weaknesses revealed by the events that led to the renewal of the medical device regime was TRACEABILITY: in which countries and in what quantity a device was on the market, and who was responsible, could not be seen quickly. When a recall decision was taken, finding the affected product took days.

The central database targets that problem: actors, devices, certificates, clinical investigations, vigilance data and market surveillance information are gathered in one place and shared between authorities.

The unique identifier given to devices is the backbone of that arrangement: different packaging levels and different versions of the same device are identified separately, so that a recall can be targeted at product level.

Registration works in stages and the order cannot be changed: actor registration is carried out first and a unique registration number is given to the organisation; device registration and all subsequent transactions are tied to that number.

That order is the point most often overlooked in planning: an organisation trying to register a device cannot begin because it has no actor number, and verifying the actor registration takes time.

For a manufacturer outside the EU there is an additional tier: registration runs through an authorised representative established in the EU and the representative must have its own registration. The scope of the representative agreement must therefore govern the registration obligations explicitly.

Registration is not a transaction carried out once and closed: the registration is updated when the device's name, class, certificate, packaging level or responsible party information changes. An un-updated registration is treated as a non-conformity.

Post-market surveillance data and incident reports are also tied to this arrangement; registration is the system's entry point and surveillance the part that is continuously fed.

A practical recommendation: a named person is identified as owner of the registration information, and an "update the registration" step is added to the change management procedure. If this step is missing from the procedure, the update is systematically skipped.