EUDAMED legacy device registration runs through a different mechanic from new MDR or IVDR registration. A legacy device has no Basic UDI-DI, so EUDAMED issues two surrogate identifiers (a EUDAMED-DI and a EUDAMED-ID) and accepts directive-era certificate metadata in place of the Notified Body data the database uses for MDR records. Regulation (EU) 2024/1860 set the timing; Commission Decision (EU) 2025/2371 fixed 28 November 2026 as the cutoff.
A legacy device is entered in the EUDAMED UDI/Devices module under a EUDAMED-DI (starting with “B”) and a EUDAMED-ID (starting with “D”), both built from the manufacturer’s SRN plus a sequence number and a check digit, with the directive certificate identification entered in place of the MDR Notified Body certificate data. Deadline: 28 November 2026.
What changed for legacy devices under Regulation (EU) 2024/1860
Regulation (EU) 2024/1860 amended the MDR and IVDR transitional provisions for legacy devices and re-shaped the EUDAMED registration timeline. Two changes matter for a manufacturer planning the registration push.
First, the registration timeline moved from the original MDR Article 123(3)(e) framing (18 months after EUDAMED becomes fully functional) to a gradual-rollout structure: each EUDAMED module activates on its own transition period once the Commission verifies functionality under MDR Article 34. For legacy devices that period is 12 months from publication of the functionality decision, set by Commission Decision (EU) 2025/2371 on 27 November 2025. The deadline lands on 28 November 2026.
Second, Regulation (EU) 2024/1860 extended the Notified Body certificate validity dates from Regulation (EU) 2023/607: Class III implantable and Class IIb implantable devices to 31 December 2027, other Class IIb and Class IIa to 31 December 2028, and up-classified Class I devices to 31 December 2028. The registration obligation is independent of those certificate dates. A device with a certificate valid until 2028 still needs an EUDAMED record by 28 November 2026.
| Provision | Pre-Regulation 2024/1860 | Post-Regulation 2024/1860 |
|---|---|---|
| Registration timeline anchor | MDR Article 123(3)(e): 18 months after EUDAMED fully functional | MDR Article 123(3) phased, started by Decision 2025/2371 |
| Legacy device cutoff | Undated; conditional on full-EUDAMED functionality | 28 November 2026 (12 months from 27 November 2025) |
| Class III implantable certificate validity | 31 December 2027 (Regulation 2023/607) | 31 December 2027 (unchanged) |
| Other Class IIb, Class IIa certificate validity | 31 December 2028 (Regulation 2023/607) | 31 December 2028 (unchanged) |
| Vigilance and PMS obligations on legacy devices | Apply under MDR Article 120(3) | Apply under MDR Article 120(3) |
The 18-month and 24-month framing that older sources still carry reflects the original Article 123(3)(e) reading and predates the 2024/1860 amendment. The 28 November 2026 cutoff replaces it.
What counts as a legacy device (and what does not)
A legacy device is a device CE-marked under Directive 93/42/EEC (MDD), 90/385/EEC (AIMDD) or 98/79/EC (IVDD) whose certificate has been extended under Regulation (EU) 2023/607 as amended by Regulation (EU) 2024/1860, and that continues to be placed on the EU market after the MDR date of application (26 May 2021) or IVDR date of application (26 May 2022). MDR Article 120(3) and IVDR Article 110(3) define the regime; MDCG 2021-25 sets out which MDR requirements apply.
Five conditions have to hold for a device to qualify:
- CE-marked under MDD 93/42/EEC, AIMDD 90/385/EEC or IVDD 98/79/EC before the relevant date of application.
- Notified Body certificate valid under Regulation (EU) 2023/607 as amended by Regulation (EU) 2024/1860.
- Written agreement with a Notified Body for MDR or IVDR conformity assessment by the dates in Regulation (EU) 2023/607.
- No significant changes to design or intended purpose that would void the extension.
- Quality management system adapted to comply with MDR or IVDR requirements (26 May 2024 for MDD/AIMDD devices; 26 May 2025 for IVDD devices).
Two adjacent categories sit outside. A directive-certified device no longer placed on the EU market after the relevant MDR or IVDR date of application is an “old device” rather than a legacy device, and is not entered in EUDAMED unless a vigilance event arises afterwards. A directive-certified device re-certified under the MDR or IVDR through a fresh conformity assessment is an MDR or IVDR device from the date of the new certificate, with a Basic UDI-DI and UDI-DI, not a EUDAMED-DI. Custom-made devices under MDR Article 2(3) are exempt from EUDAMED device registration regardless of certification regime.
How EUDAMED-DI and EUDAMED-ID are assigned to a legacy device
The MDR makes the Basic UDI-DI and UDI-DI the access keys for any device record in EUDAMED. Legacy devices were never required to carry these identifiers under the Directives, so registering them in the same database would otherwise be technically impossible. MDCG 2019-5 set out the resolution: assign two surrogate identifiers (a EUDAMED-DI in place of the Basic UDI-DI and a EUDAMED-ID in place of the UDI-DI) that the database itself issues. The mechanic is implemented in the live EUDAMED UDI/Devices module and documented in the EC Legacy Devices user guide.
The structure is fixed by MDCG 2019-5. A EUDAMED-DI begins with the character “B” and a EUDAMED-ID begins with the character “D”; the prefix is the only difference between them. Both contain the manufacturer’s Single Registration Number (SRN), a sequence number and a check digit, and the relationship between a EUDAMED-DI and a EUDAMED-ID is one-to-one.
The EUDAMED-DI can be either fully generated by EUDAMED or partly assigned by the manufacturer; the EUDAMED-ID is always fully generated by EUDAMED from the EUDAMED-DI. The sequence number is the lever for partial assignment, allowing a manufacturer with an internal product-numbering scheme to keep EUDAMED records aligned with their own catalogue. Two paths cover the population in practice.
| Path | When it applies | What the manufacturer enters | What EUDAMED issues |
|---|---|---|---|
| Option 1: no UDI-DI exists | The legacy device has no UDI-DI assigned (the typical case under the Directives) | SRN, optional sequence portion, certificate metadata | EUDAMED-DI (B-prefixed) and EUDAMED-ID (D-prefixed) |
| Option 2: a UDI-DI already exists | The manufacturer issued a UDI-DI for logistical reasons (typically a GTIN) before MDR application | SRN, the existing UDI-DI as device identifier, certificate metadata | EUDAMED-DI (B-prefixed) generated alongside the existing UDI-DI |
Neither the EUDAMED-DI nor the EUDAMED-ID can be reused under the MDR or IVDR. When a legacy device transitions to MDR or IVDR conformity assessment, the manufacturer assigns a fresh Basic UDI-DI through a recognised issuing entity (GS1, HIBCC, IFA or ICCBBA) and registers the device as a new MDR or IVDR record. EUDAMED supports linking the new record to the legacy record at the UDI-DI level so regulatory history is preserved.
Alongside the identifiers, the legacy record carries the directive-era certificate identification: the four-digit Notified Body number, certificate number, revision number and expiry date. The manufacturer enters these fields directly (a difference from the MDR record, where the Notified Body registers its certificate in the Notified Bodies & Certificates module).
The corresponding-device exception and the vigilance trigger
Two non-obvious rules determine whether a given legacy device actually needs a separate EUDAMED record, and when an apparently-exempt device suddenly becomes registration-required.
The corresponding-device exception applies when an MDR or IVDR device covering the same identification, risk class and characteristics as the legacy device is already registered in EUDAMED. MDCG 2019-5 frames this as the link-and-copy mechanic: EUDAMED facilitates the copy process and links the legacy device to the corresponding MDR device, with only the UDI-DI entered where another device with the same Basic UDI-DI is already registered. For a portfolio running legacy and MDR variants of the same product in parallel during transition, this removes the requirement for a separate legacy record.
The vigilance trigger is the override. MDCG 2019-5 Annex point 2 requires that where a serious incident or field safety corrective action arises for a legacy device not yet in EUDAMED, the device must be registered at the moment of reporting. The same rule applies to devices placed on the market under the Directives that were not intended for continued placing if a vigilance event arises after the MDR date of application.
The Article 87 MDR reporting windows make the urgency concrete: 2 calendar days for a serious public-health threat, 10 calendar days for a death or unanticipated serious deterioration in health, 15 calendar days for any other serious incident. A manufacturer that hits a vigilance event on an unregistered legacy device has to complete actor registration, generate the EUDAMED-DI and submit the device record inside those windows. Pre-emptive registration ahead of any vigilance event is the simpler path for any legacy device kept on the market through the extension period.
The 28 November 2026 deadline (and how it interacts with certificate extensions)
The 28 November 2026 cutoff is fixed by Commission Decision (EU) 2025/2371 published on 27 November 2025. The 12-month transition period in MDR Article 123(3) for legacy device EUDAMED entry starts on the publication date; the obligation bites the day after the period ends. For the date-discrepancy discussion (and why some sources cite 27 November), see the EUDAMED registration deadlines page.
The interaction this page covers, which the deadlines page does not, is between the registration cutoff and the certificate-extension end dates. The two timelines run in parallel but are independent. Certificate-extension end dates set by Regulation (EU) 2024/1860 (amending Regulation (EU) 2023/607) govern how long a legacy device may stay on the EU market. The 28 November 2026 cutoff governs by when the EUDAMED record has to exist.
| Risk class | Certificate validity end date | EUDAMED registration deadline |
|---|---|---|
| Class III implantable, Class IIb implantable | 31 December 2027 | 28 November 2026 |
| Other Class IIb, Class IIa | 31 December 2028 | 28 November 2026 |
| Class I (up-classified under MDR) | 31 December 2028 | 28 November 2026 |
| Class I (not up-classified, with Directive certificate) | Per Regulation 2023/607 as amended | 28 November 2026 |
A device with a certificate valid until 2028 still needs an EUDAMED record by 28 November 2026. The cutoff is upstream of the sales deadline.
Walkthrough: registering a single legacy device in EUDAMED
The end-to-end path runs in 10 steps. EUDAMED enforces the order; the actor record has to exist before the device record can be filed.
- Confirm the device qualifies under the five conditions above. If any condition fails, the device is either an old device (no registration) or a new MDR or IVDR device (Basic UDI-DI route, not legacy).
- Apply the corresponding-device check. If a corresponding MDR or IVDR device is already registered, file the link at UDI-DI level under the link-and-copy mechanic rather than a separate legacy record.
- Complete actor registration. The Actor module issues the manufacturer’s SRN; the UDI/Devices module rejects any submission citing an inactive SRN. Competent authorities target 30 days for actor review but the window can run longer.
- Choose the identifier path. If a UDI-DI already exists (typically a GTIN issued for logistics), select Option 2 and supply the UDI-DI alongside the SRN. Otherwise select Option 1 and accept the EUDAMED-DI and EUDAMED-ID that EUDAMED generates.
- Enter the device identification data: name, model, intended purpose, applicable legislation (MDD, AIMDD or IVDD), risk class under the Directive, and the EMDN code.
- Enter the device flags the UDI/Devices module requires: sterile, single-use, measuring function, implantable, contains medicinal substance, contains animal-origin material.
- Enter the directive certificate identification: Notified Body four-digit identifier, certificate number, revision number and expiry date. Add the certificate-extension reference under Regulation (EU) 2023/607 as amended by Regulation (EU) 2024/1860 if applicable.
- Validate the record against the EUDAMED business rules before submission. The portal returns rule-by-rule errors on any field that fails.
- Submit the device record. EUDAMED links it to the SRN and certificate metadata.
- If an MDR or IVDR successor is registered later, link the legacy record at the UDI-DI level so regulatory history carries forward.
If actor registration is complete, the EUDAMED entry point is webgate.ec.europa.eu/eudamed/landing-page. For portfolios above ~50 legacy devices, manual entry scales poorly; the bulk-upload XML path against the published XSD schemas is the route, covered in the EUDAMED registration pillar.