EUDAMED FAQ: deadlines and what must be registered

By the eudaflow team · Published: 2 October 2026

When devices must be registered in EUDAMED, which rule applies to old and new devices, what national rules remain and what comes after 28 November 2026.

Six questions we hear most often about the EUDAMED registration dates. Every answer rests on a European Commission document, the MDR or the IVDR, and the source is named under the answer. Where the sources say nothing, the answer says so.

What must be registered in EUDAMED by 28 November 2026?

Devices that were already on the EU market before 28 May 2026 and are still being sold on or after that date must be registered in EUDAMED by 28 November 2026. This covers legacy devices and devices already placed on the market under the MDR or IVDR. A Regulation device whose first unit is placed on the market on or after 28 May 2026 must be registered before that first unit is placed on the market.

The dates come from a chain of steps. The Commission Decision confirming that the first four EUDAMED modules work was published in the Official Journal on 27 November 2025. That started a transition period of six months, so the Actor, UDI/Device, Notified Bodies and Certificates and Market Surveillance modules have been mandatory since 28 May 2026. The 12 months the MDR gives manufacturers to enter their device data run from the same notice, which is why the Commission's timetable shows 28 November 2026.

One registration covers all individual devices with the same device identifier, so a manufacturer registers a UDI-DI once, not once per unit sold.

Sources: EUDAMED overview; Commission Q&A on the gradual roll-out, Q7; timetable for devices placed on the market before mandatory use; MDR Article 123(3)(e). Last checked 29 September 2026.

First unit sold before or after 28 May 2026: which rule applies?

Look at when the first unit with that UDI-DI was placed on the EU market. If it was on or after 28 May 2026, a Regulation device must be registered before that first unit is placed on the market. If it was before 28 May 2026 and more units of the same UDI-DI are sold on or after that date, the deadline is 28 November 2026.

Some devices need no registration at all:

Devices that are no longer sold when the module became mandatory, unless a vigilance or post-market surveillance action occurs for them.
Custom-made devices, investigational devices and devices for performance studies.
A legacy device, if the same device is already registered as a Regulation device.

"The same device" means the same identification: the UDI-DI, or the catalogue or reference number, or the trade name that follows from shared characteristics. A Regulation device changed enough to need a new UDI-DI is not the same device.

One exception matters. If a serious incident or a field safety corrective action concerns the legacy device and not the same Regulation device, the legacy device must be registered so that the report can be entered.

The Commission's before-the-first-unit rule is written for Regulation devices and for system and procedure packs. For a legacy device, the Q&A gives only the 12-month rule.

Sources: Commission Q&A, Q7, Q8 and Q14; timetable for the six-month transition. Last checked 29 September 2026.

Do Class I devices or IVDs get a later registration deadline?

No. In the Commission's overview, Q&A and timetables we found no registration date that depends on the risk class. One rule covers device registration under Article 29 MDR and Article 26 IVDR. For IVDs the regulation gives manufacturers six months after the mandatory-use date, which adds up to the same twelve months as under the MDR.

The class-based dates you may have seen are about something else. The MDR transitional provisions set staggered dates for the UDI carrier on the label under Article 27(4): 26 May 2025 for Class I devices, for example. They do not move the EUDAMED registration date.

Sources: Commission Q&A, Q7; IVDR Article 113(3); MDR Article 123(3). Last checked 29 September 2026.

What happens if a device is not registered on time?

The Commission documents we checked do not state a consequence. The MDR leaves penalties to the Member States: they lay down the rules, and the penalties must be effective, proportionate and dissuasive. What follows in practice therefore depends on the authority of the country where you sell.

The duty itself is written plainly. Before placing a device other than a custom-made device on the market, the manufacturer assigns a Basic UDI-DI and provides it to the UDI database together with the core data elements in Part B of Annex VI.

If you expect to miss a date, ask your national competent authority how it treats late registrations. The rules can differ from one Member State to the next.

Sources: MDR Article 113 and Article 29(1). Last checked 29 September 2026.

Does EUDAMED replace national device registration?

Not everywhere and not for everyone. Once an EUDAMED module is mandatory, the provisions of the old directives that it replaces stop applying, and so do the national measures that implemented them. For device registration this means the registration in EUDAMED becomes the legally required one, even if the device is also registered in a national system.

EUDAMED does not replace every national register:

Distributors do not register in EUDAMED, and the MDR lets Member States keep or introduce national rules on registering distributors.
If you also sell in Türkiye, the Turkish authority TİTCK registers devices and their documents in its own system, ÜTS (Ürün Takip Sistemi). That is a national system outside EUDAMED.

Before a module became mandatory, the directive provisions on registering devices and economic operators, and national registration requirements, continued to apply.

Sources: MDR Article 123(3)(d) and Article 30(2); Commission Q&A, Q2, Q5 and Q9; TİTCK, Ürün Takip Sistemi. Last checked 29 September 2026.

What comes after 28 November 2026?

Two dates are fixed, one module has a planned date, and one module has none.

27 February 2027: manufacturers should upload the summaries of safety and clinical performance, SS(C)P, of devices placed on the market before mandatory use by this date at the latest (MDCG 2026-4). The manufacturer upload feature was planned for Production in October 2026. Until it is live, notified bodies upload the SS(C)P together with new certificates.
28 May 2027: the Commission's timetable date for registering certificates issued under the MDR or IVDR before the certificates module became mandatory. Notified bodies do this registration, within 18 months of the notice. It is not a manufacturer deadline.
Vigilance and post-market surveillance: this module covers periodic safety update reports, serious incident reports, field safety corrective actions and trend reports. It becomes mandatory six months after the Commission publishes a functionality notice, and it has no voluntary phase. The Commission's November 2025 roadmap planned the notice for the fourth quarter of 2026 and mandatory use for the second quarter of 2027, and says the timeline may change with the audit results. As of 29 September 2026 the Commission still lists the module as "in development". Until it is live, the national vigilance processes continue.
Clinical investigations and performance studies: the Commission lists this module as "under analysis". No date exists.

Every year in December or January the Commission also publishes the changes to the EMDN nomenclature, without notifying users one by one.

Sources: MDCG 2026-4; certificates timetable; modules timeline, November 2025; EUDAMED overview; Commission Q&A, Q10, Q12 and Q13. Last checked 29 September 2026.

Sources and how we checked

Every statement above is tied to a quote in a claims register, and a script compares each quote with the current text of its source before we publish. The register is in our repository under marketing/faq/.

The Commission's Q&A on the gradual roll-out carries no date and states that it has not been formally endorsed by the European Commission. The dates in it match the Commission's timetables and the MDR. Read the current official text before you rely on a date for a specific submission. This page is general information, not legal advice.

The Commission, not eudaflow, sets these dates. eudaflow is not affiliated with the European Commission.