For years, EUDAMED was something manufacturers could use if they wanted to. Many registered as actors and stopped there, while device records stayed in spreadsheets and national databases. That changed on 28 May 2026. Notified bodies, importers and competent authorities now expect to see your single registration number (SRN) and your devices in EUDAMED, and the window to register devices that were already on the market closes on 28 November 2026.
The difficulty is that EUDAMED mandatory registration does not apply to the whole database at once. Some modules are mandatory, others are still in development, and the deadlines differ for manufacturers and notified bodies. This guide sets out which modules apply, the dates that matter, and exactly what manufacturers must register.
The legal trigger: Commission Decision (EU) 2025/2371
Article 34 MDR requires the Commission, once independent audits confirm that EUDAMED systems work, to publish a notice in the Official Journal. Regulation (EU) 2024/1860, adopted on 13 June 2024 and published on 9 July 2024, changed the MDR and IVDR so that each electronic system can become mandatory on its own, rather than waiting for the whole database. Under the amended Article 123(3)(d) MDR, obligations relating to a system apply six months after the notice declaring it functional. Article 113(3)(f) IVDR mirrors this.
That notice is Commission Decision (EU) 2025/2371 of 26 November 2025, published in the Official Journal on 27 November 2025. Article 1 confirms that four electronic systems “have achieved functionality and meet the functional specifications”. The Decision rests on an independent audit report of 18 June 2025 and entered into force on the day of publication.
Which EUDAMED modules are mandatory
| EUDAMED module | MDR article | IVDR article | Who enters the data | Mandatory from |
|---|---|---|---|---|
| Actor registration | Article 30 | Article 27 | Manufacturers, authorised representatives, importers | 28 May 2026 |
| UDI/Device registration | Articles 28 and 29 | Articles 25 and 26 | Manufacturers | 28 May 2026 |
| Notified bodies and certificates | Article 57 | Article 52 | Notified bodies | 28 May 2026 |
| Market surveillance | Article 100 | Article 95 | Competent authorities and the Commission | 28 May 2026 |
Two modules are not covered by the Decision: Vigilance and post-market surveillance, and Clinical investigations and performance studies. The Commission’s EUDAMED pages describe them as in development, and state that there will be no voluntary-use period before they become mandatory. No mandatory date can be given for them until a notice is published under Article 34(3) MDR, which would start its own six-month clock.
The dates that matter for EUDAMED mandatory registration
- 27 November 2025 — Decision (EU) 2025/2371 published in the Official Journal.
- 28 May 2026 — the four modules become mandatory to use. From this date, a new device must be registered before it is placed on the market, and any new MDR or IVDR certificate must be registered in EUDAMED.
- 28 November 2026 — deadline for manufacturers to register devices that were placed on the market before 28 May 2026 and are still being placed on the market. Under the MDR this is “no later than 12 months from the date of publication of the notice” (Article 123(3)(e)); under the IVDR, six months from the mandatory-use date (Article 113(3)(fa)).
- 28 May 2027 — deadline for notified bodies to register certificates issued before mandatory use: 18 months from the notice under Article 123(3)(ea) MDR, and 12 months from the mandatory-use date under Article 113(3)(fb) IVDR.
The 28 November 2026 deadline is covered in more detail in our article on the 28 November 2026 deadline for existing devices.
What manufacturers must register
Actor registration and the SRN
Under Article 31 MDR (Article 28 IVDR), manufacturers, authorised representatives and importers must register before placing a device, other than a custom-made device, on the market. After verifying the data, the competent authority issues a single registration number. The manufacturer uses the SRN when applying to a notified body and when accessing EUDAMED for device registration. Changes must be updated within one week, and the data must be confirmed one year after submission and every two years after that. Non-EU manufacturers should coordinate this with their authorised representative; see the duties of an EU authorised representative.
UDI and device registration
Article 29 MDR requires the manufacturer to assign a Basic UDI-DI before placing a device, other than a custom-made device, on the market, and to provide the required data to the UDI database, keeping it up to date. Article 26 IVDR follows the same pattern.
Devices already on the market
The 28 November 2026 deadline covers, provided the device is still placed on the market from 28 May 2026:
- devices certified under Article 52 MDR (Article 48 IVDR), other than custom-made devices;
- legacy devices placed on the market under Article 120(3), (3a) or (3b) MDR, or Article 110(3), (3a) or (3b) IVDR, unless the regulation version of the device is already registered.
The legacy routes and their end dates are explained in our guides to MDR transition deadlines for legacy devices and IVDR transition periods.
The vigilance trigger
Article 123(3)(ec) MDR adds a further rule: when a manufacturer submits a PSUR, reports a serious incident or field safety corrective action, or submits a trend report, it must also register the device concerned in the actor and UDI/device systems. This does not apply to devices placed on the market under Directives 90/385/EEC or 93/42/EEC. Article 113(3)(fd) IVDR has the same rule, with the exception for Directive 98/79/EC devices.
What notified bodies register, and why it affects you
For certificates issued before mandatory use, notified bodies enter only the latest relevant certificate and any later decision related to it. Under Article 123(3)(eb) MDR, the obligations to upload the summary of safety and clinical performance and to notify competent authorities through EUDAMED apply to those devices once the certificate is entered. A certificate cannot link to a device record that does not exist, so manufacturers who register late hold up their notified body.
Where this goes wrong
- Registering the actor and stopping. An SRN alone does not satisfy Article 29. Each device needs its Basic UDI-DI and UDI data in the UDI/Device module.
- Forgetting legacy devices. Devices sold under Article 120(3) MDR are in scope if they are still being placed on the market, even though they are not yet MDR-certified.
- Assuming Class I and self-certified IVDs are exempt. There is no notified body prompting these manufacturers, so they are the most likely to miss 28 November 2026.
- Inconsistent data. Device names, Basic UDI-DIs and certificate references that differ between EUDAMED, the label and the technical documentation trigger questions from notified bodies and authorities.
- Leaving the authorised representative out. For non-EU manufacturers, actor data, mandates and SRNs must match. Mismatches delay device registration.
- Waiting for the vigilance module. Serious incident and PSUR obligations apply now through the existing routes; the absence of a mandatory vigilance module is not a reprieve.
- Ignoring the PSUR trigger. A vigilance report or PSUR for a device not yet registered obliges you to register it under Article 123(3)(ec).
Frequently asked questions
Is EUDAMED mandatory now?
Partly. Since 28 May 2026, four modules have been mandatory: Actor registration, UDI/Device registration, Notified bodies and certificates, and Market surveillance. This follows Commission Decision (EU) 2025/2371, published in the Official Journal on 27 November 2025, and the six-month period set by Regulation (EU) 2024/1860. The vigilance and clinical investigation modules are not yet mandatory.
What is the deadline to register devices already on the market?
28 November 2026, for devices placed on the market before 28 May 2026 that are still being placed on the market after that date. This includes MDR-certified devices and legacy devices under Article 120(3), (3a) or (3b) MDR, and the IVDR equivalents. Custom-made devices are excluded. New devices must be registered before they are placed on the market.
Do I need to register devices I no longer sell?
The 28 November 2026 deadline only covers devices still placed on the market from 28 May 2026. However, under Article 123(3)(ec) MDR, if you submit a PSUR, a serious incident report, a field safety corrective action or a trend report for a device, you must register that device, unless it was placed on the market under Directive 90/385/EEC or 93/42/EEC.
When do notified bodies have to register older certificates?
By 28 May 2027. Certificates issued before mandatory use must be entered by then, limited to the latest relevant certificate and any later related decision. New MDR and IVDR certificates issued since 28 May 2026 must be registered as they are issued. Manufacturers should register their devices first, so certificates can be linked to them.
When will the EUDAMED vigilance module become mandatory?
No date has been set at a primary source. The Commission describes the vigilance and post-market surveillance module as in development. It will become mandatory six months after the Commission publishes a notice in the Official Journal confirming its functionality, with no voluntary-use period beforehand. Until then, report incidents through the existing national routes.
If you need help checking your actor data, assigning Basic UDI-DIs or registering legacy and MDR devices before the deadline, Medfins can help. We have supported 175+ regulatory projects covering 250+ products for 100+ clients. See our CE marking support under EU MDR and IVDR, or contact our regulatory team.
