EUDAMED registration in 2026 turns on two dates. The 28 May 2026 cutoff brought the Actor, UDI/Devices, Notified Bodies & Certificates and Market Surveillance modules into mandatory use for new MDR and IVDR submissions. The 28 November 2026 cutoff brings legacy devices, those with certificates extended under Regulation (EU) 2024/1860, into the same database. Both dates are anchored in Commission Decision (EU) 2025/2371 and the transitional provisions of MDR Article 120 and IVDR Article 110.
28 May 2026. Mandatory EUDAMED use begins for new device registrations under MDR and IVDR, and for actor records.
28 November 2026. Legacy devices on extended certificates under Regulation (EU) 2024/1860 must also be in EUDAMED.
Both dates are set by Commission Decision (EU) 2025/2371, published in the Official Journal on 27 November 2025.
The two deadlines at a glance
The 28 May 2026 deadline applies to manufacturers placing new MDR or IVDR devices on the EU market and to every economic operator that needs an actor record. The 28 November 2026 deadline applies to legacy MDD, AIMDD and IVDD devices that remain on the market under the extended-certificate regime of Regulation (EU) 2024/1860. Both deadlines flow from the same Commission Decision; only the device population differs.
| Deadline | Devices affected | Legal source | Status |
|---|---|---|---|
| 28 May 2026 | New MDR and IVDR device registrations; actor records for every economic operator placing devices on the EU market | MDR Article 123(3)(d), IVDR Article 113(3)(f); Commission Decision (EU) 2025/2371 | Passed |
| 28 November 2026 | Legacy MDD, AIMDD and IVDD devices on extended certificates under Regulation (EU) 2024/1860 | MDR Article 120(3a)–(3c) as amended; Regulation (EU) 2024/1860; Commission Decision (EU) 2025/2371 | Upcoming |
Four EUDAMED modules carry the obligations. The Actor module registers economic operators and issues the Single Registration Number (SRN). The UDI/Devices module holds Basic UDI-DI and UDI-DI records for new MDR and IVDR devices, and an EUDAMED-DI record for legacy devices. The Notified Bodies & Certificates module surfaces the certificate linkage on the device record. The Market Surveillance module is competent-authority-facing. Two further modules, Vigilance and Post-Market Surveillance and Clinical Investigations & Performance Studies, are not yet declared functional; the EC’s published roadmap targets later 2026 for the Vigilance and PMS module, with a separate Commission decision required before it goes mandatory.
What changed on 28 May 2026
On 28 May 2026 the Actor, UDI/Devices, Notified Bodies & Certificates and Market Surveillance modules transitioned from voluntary to mandatory use. After that date, a new device registration under MDR Article 29 or IVDR Article 26 has to be entered in EUDAMED rather than communicated through the national systems some Member States previously accepted. Actor registration under MDR Article 31 and IVDR Article 28 became a precondition: an economic operator without an approved SRN cannot file a device record, because the device modules reject submissions citing an SRN that is not yet active.
The 28 May 2026 cutoff was not extended. Pre-cutoff, several consultancies framed the date as conditional on the European Commission’s functionality audit. The audit completed on 18 June 2025, the Commission verified functionality under MDR Article 34(2) on that basis, and Commission Decision (EU) 2025/2371 was adopted on 26 November 2025 and published in the Official Journal on 27 November 2025. From the publication date, the transition periods set in MDR Article 123(3)(d) to (ec) and IVDR Article 113(3)(f) to (fd) began to run.
The mandate covers Class I manufacturers and higher-risk classes alike. Risk class does not change the obligation: every economic operator placing a device on the EU market under MDR or IVDR needs an active actor record and the relevant device records. For the full mandate sequence, see the EUDAMED registration pillar; the actor record comes first, then Basic UDI-DI, then UDI-DI.
The 28 November 2026 legacy device deadline
A legacy device is an MDD, AIMDD or IVDD device that was lawfully on the EU market before MDR or IVDR took effect, where the underlying certificate has been extended under Regulation (EU) 2023/607 and subsequently Regulation (EU) 2024/1860. These devices remain on the market without fresh MDR or IVDR conformity assessment for the period the extended-certificate regime allows. From 28 November 2026 they must also be recorded in EUDAMED.
The mechanic differs from the new-device path in one important respect. A legacy device does not need a Basic UDI-DI assigned by a UDI issuing entity. The UDI/Devices module accepts an EUDAMED-DI identifier instead, generated for the legacy record inside EUDAMED. The MDCG legacy-device guidance documents the EUDAMED-DI route and the data required for each legacy record.
Three checks settle whether the 28 November 2026 deadline applies to a given device:
- Was the device placed on the EU market under MDD, AIMDD or IVDD before the relevant transition date (26 May 2021 for MDD and AIMDD devices, 26 May 2022 for IVDD devices)?
- Is the underlying certificate currently valid under the extension regime of Regulation (EU) 2023/607 as further amended by Regulation (EU) 2024/1860?
- Has the device been placed on the EU market continuously since, without significant changes in design or intended purpose that would void the extension?
If the answer to all three is yes, the device qualifies for the legacy path and needs an EUDAMED record by 28 November 2026.
Notified Body involvement remains required for class IIa and above legacy devices. The Notified Body that originally certified the device continues to hold certificate visibility obligations, and the Notified Bodies & Certificates module surfaces that linkage on each device record. For class I legacy devices without a Notified Body, the manufacturer submits the EUDAMED record directly.
27 November or 28 November 2026? Resolving the date discrepancy
The 28 November 2026 reading is correct. Some commentators report the legacy deadline as 27 November 2026. The discrepancy traces to two ways of expressing the same arithmetic, not to two different dates in the underlying text.
Commission Decision (EU) 2025/2371 was published in the Official Journal on 27 November 2025. The Decision itself does not set the deadline directly. Article 2 of the Decision reads:
This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.
The transition periods sit elsewhere, in MDR Article 123(3)(d) to (ec) and IVDR Article 113(3)(f) to (fd), and the Decision is the event that starts them running. Recital 5 of the Decision confirms that the transition periods “are to start as from the date of publication of this Decision.” MDR Article 123(3) sets a 12-month period for the legacy-device EUDAMED entry obligation. Under EU time-period rules, a period expressed in months ends on the same date in the last month; 12 months from 27 November 2025 ends on 27 November 2026, and mandatory use begins the day after.
The EC’s own notice expresses the equivalent 6-month obligation as mandatory “as from 28 May 2026”, confirming the convention. Two phrasings, one date: “by 27 November 2026” describes the last day before the obligation bites, and “from 28 November 2026” describes the first day it does. For the question a manufacturer asks, the operative answer is 28 November 2026.
What EUDAMED registration costs (and what it does not)
EUDAMED itself charges no fee. The European Commission operates the database as public infrastructure under MDR Article 33, funded from the EU budget and confirmed on the EC EUDAMED tools page. The cost a manufacturer encounters is preparation cost, not registration cost.
Four components drive that preparation cost:
| Component | Who pays | Approximate range |
|---|---|---|
| UDI issuing-entity fees (Basic UDI-DI assignment for new devices) | Manufacturer, to a recognised issuing entity (GS1, HIBCC, IFA or ICCBBA) | Annual fee, varies by issuing entity |
| EU Authorised Representative fee (non-EU manufacturers under MDR Article 11) | Manufacturer, to the appointed AR | Varies by provider; commonly low-to-mid four figures per year |
| External RA consultancy (where outsourced) | Manufacturer | Project-based; varies widely |
| Internal RA and PRRC time (preparation, mapping, review) | Manufacturer | The largest component for most portfolios |
Public market anchors put total preparation cost in two bands. At the managed-service end, flat-fee arrangements run in the low thousands per device per year. At the project-based end, single-burst compliance costs fall in the $5,000 to $25,000 range across the registration push. Neither is an EC-set fee. The right number for any given portfolio depends on the number of devices, the legacy share, whether the manufacturer holds an EU establishment, and how much of the work the in-house RA team owns.
What to do if your legacy device portfolio is not yet in EUDAMED
If your legacy portfolio is not yet entered, the path runs in six steps. Run them in order; the database enforces the sequence regardless of portfolio size.
- Count the legacy devices in scope. List every MDD, AIMDD or IVDD device still on the EU market that you intend to continue placing under the extension regime.
- Confirm the extended-certificate status for each device under Regulation (EU) 2023/607 as further amended by Regulation (EU) 2024/1860. A device whose certificate has lapsed or whose conditions are not met falls outside the legacy path.
- Identify Notified Body involvement. For class IIa and above legacy devices, locate the Notified Body that holds the certificate and confirm the certificate is registered in the Notified Bodies & Certificates module.
- Register the actor first. The Actor module issues your SRN; the UDI/Devices module rejects any submission citing an SRN that is not yet active. Competent authorities target a 30-day review on actor requests, but the window can run longer.
- Assemble the legacy-record content per device. The UDI/Devices module requires the EMDN code, risk class, intended purpose, applicable legislation, sterile / single-use / implantable flags, and the legacy certificate reference, mapped to the EUDAMED-DI identifier.
- Submit the device records. For small portfolios this is manual entry through the EUDAMED interface; for larger portfolios the bulk-upload path runs against the published XSD schemas.
If you have already completed actor registration, you can sign in to EUDAMED at webgate.ec.europa.eu/eudamed/landing-page.
Bulk upload via XML is the route for portfolio-scale registration. The Commission publishes XSD schemas defining the structure for actor and device submissions; a manufacturer prepares an XML file conforming to the relevant XSD, validates it against the schema and the EC business rules, then uploads the file through the portal. The XSD pack and the conformance documentation are available from the EC EUDAMED Information Centre. Bulk upload does not change the deadlines or the data EUDAMED requires; it changes how the records reach the portal.