What Is a Legacy Device
MDCG 2021-25 Rev.1 (October 2024), the current Medical Device Coordination Group guidance on this topic, defines legacy devices as devices which, in accordance with MDR Article 120, are placed on the market or put into service after the MDR's date of application and until the extended transitional dates set by Regulation (EU) 2023/607. That covers two situations: Class I devices under the MDD for which a declaration of conformity was drawn up before May 26, 2021 but which need Notified Body involvement under the MDR, and devices covered by a valid EC certificate issued under the AIMDD or MDD before that date.
This is a narrower category than every device manufactured before the MDR applied. MDCG 2021-25 Rev.1 separately defines "old" devices as those placed on the market or put into service before May 26, 2021; old devices are subject to a different, shorter list of MDR requirements (serious incident and field safety corrective action reporting under Article 87, and the market surveillance provisions in Articles 93 to 100) that this guide does not cover. This guide is about legacy devices under the definition above, registered and still being placed on the market under their Directive certificate.
Two Different Deadlines
Manufacturers preparing legacy device data routinely conflate two mechanisms that are legally independent of each other.
The market-placement extension: December 2027 or December 2028
Regulation (EU) 2023/607 extended how long a legacy device can keep being placed on the market under its Directive certificate. MDCG 2021-25 Rev.1 states the dates directly: December 31, 2027 for Class III devices and Class IIb implantable devices (with a named list of exceptions such as sutures, staples, and dental fillings), and December 31, 2028 for other Class IIb devices, Class IIa devices, and Class I devices placed on the market sterile or with a measuring function. These dates apply only if the manufacturer put a compliant quality management system in place by May 26, 2024 and lodged a formal Notified Body application by the same date, among other conditions in the regulation.
The EUDAMED registration deadline: November 27, 2026
This is a separate clock, covered in detail in our guide to the November 2026 deadline. MDCG 2021-25 Rev.1's requirements table is explicit that device registration under MDR Article 29 applies to legacy devices "in principle," subject to the transitional timing in MDR Article 123(3), the same provision that sets the November 27, 2026 deadline for every other device category.
The EUDAMED DI Mechanism
MDCG 2019-5 (April 2019) is the source document for this mechanism. It reasoned that since MDR Article 29 registration and the EUDAMED database design use the Basic UDI-DI and UDI-DI as the primary access keys, and since the MDR does not explicitly require legacy devices to carry a UDI, the database needed a parallel identification path so legacy device registration would not be technically blocked by the absence of a UDI.
The result: EUDAMED assigns a EUDAMED DI to the device in place of the MDR Annex VI Part C Basic UDI-DI, and a EUDAMED ID in place of the UDI-DI. The EUDAMED ID is generated automatically by the system from the EUDAMED DI; the two form a one-to-one relationship, the same structural role the Basic UDI-DI and UDI-DI play for MDR devices under MDR Annex VI Part C Section 3.9.
MDCG 2021-25 Rev.1, the current (October 2024) guidance, confirms this has not changed: its requirements table lists MDR Article 27UDI obligations as not applicable to legacy devices and cites MDCG 2019-5 by name for that point. The Commission's document portal separately marked MDCG 2019-5 itself archived in December 2024, and the document is now stamped obsolete; treat it as historical background rather than standalone current authority. The specific point this guide relies on it for, that Article 27 does not apply to legacy devices, is the one MDCG 2021-25 Rev.1 independently confirms as current.
What Data Is Required
MDR Article 29 requires every device registration to include the information in Section 2 of Part A of Annex VI. That requirement is not conditional on device type, so it applies to legacy devices as well. The separate Annex VI Part B technical dataset, by contrast, is structured around the UDI-DI: MDR Article 27defines the UDI-DI specifically as the identifier that provides access to the Part B information. Since Article 27 UDI obligations do not apply to legacy devices (the point MDCG 2019-5 established and MDCG 2021-25 Rev.1's requirements table confirms), the Part B dataset that is keyed to a UDI-DI has no legacy-device equivalent to attach to.
MDCG 2019-5 separately requires the manufacturer to enter the Directive certificate identification at registration: Notified Body number, certificate number, revision number, and expiry date, because legacy devices are not registered in EUDAMED by the Notified Body the way MDR-certified devices are.
MDR Article 31 registration of the manufacturer, and the Authorised Representative if the manufacturer is outside the EU, is a precondition for device registration for legacy devices exactly as it is for new MDR devices. Nothing in MDCG 2019-5 or MDCG 2021-25 Rev.1 waives actor registration for legacy device manufacturers.
Field Differences vs. a New MDR Device
| Data Point | New MDR/IVDR Device | Legacy Device (MDD/AIMDD) |
|---|---|---|
| Primary device identifier | Basic UDI-DI, obtained from a UDI issuing entity (GS1, HIBCC, ICCBBA, or IFA) | EUDAMED DI, assigned through EUDAMED; no issuing entity involved |
| Model-level identifier | UDI-DI | EUDAMED ID, generated automatically by EUDAMED from the EUDAMED DI |
| Conformity reference | MDR/IVDR Notified Body certificate, cross-checked in the certificate module | Directive certificate identification: Notified Body number, certificate number, revision number, expiry date |
| UDI carrier / label marking data | Required under Article 27 | Not applicable; no UDI is assigned |
| Annex VI Part B technical dataset | Required, keyed to the Basic UDI-DI | Not required; only the Annex VI Part A Section 2 registration dataset applies |
| EUDAMED registration deadline | November 27, 2026, under Article 123(3) | Same November 27, 2026 deadline under Article 123(3); the Article 120(3a) market-placement extension does not change it |
Common Mistakes
| Mistake | What Actually Happens | Prevention |
|---|---|---|
| Assuming the 2027/2028 sell-off extension also extends the EUDAMED registration deadline | Registration is still due November 27, 2026 regardless of how long the certificate remains valid for market placement | Track the two dates separately in your portfolio plan; do not let one certificate field drive both |
| Trying to obtain a Basic UDI-DI for a legacy device before registering | Unnecessary step and cost; EUDAMED assigns a EUDAMED DI, no issuing entity transaction is needed | Confirm device status (legacy vs. MDR) before starting any UDI issuing entity process |
| Entering the internal tracking number instead of the Directive-era certificate detail | Registration record cannot be cross-checked against the Notified Body's own certificate data | Pull Notified Body number, certificate number, revision number, and expiry date directly from the Directive certificate document |
Preparation Checklist
- Confirm each device still holds a valid MDD or AIMDD certificate and qualifies as "legacy" rather than "old" under MDCG 2021-25 Rev.1's definitions
- Separately record the market-placement extension date (December 2027 or 2028, if applicable) and the November 27, 2026 EUDAMED registration deadline; do not merge them into one field
- Confirm manufacturer, and Authorised Representative if applicable, actor registration is active before preparing device records
- Pull the Directive certificate's Notified Body number, certificate number, revision number, and expiry date from the certificate document itself
- Do not initiate a UDI issuing entity transaction for devices that remain legacy; EUDAMED handles identifier assignment
The EUDAMED DI mechanism exists specifically so legacy devices are not blocked from registering by the absence of a UDI. That makes the data problem smaller than for a new MDR device, not larger, provided the two deadlines are tracked separately and the Directive certificate detail is pulled from the source document rather than reconstructed from memory.
Frequently Asked Questions
Does a legacy device need a Basic UDI-DI to register in EUDAMED?
No. MDCG 2019-5, reaffirmed on this point by MDCG 2021-25 Rev.1's requirements table, states that Article 27 UDI obligations do not apply to legacy devices. EUDAMED assigns a EUDAMED DI in place of the Basic UDI-DI and a EUDAMED ID in place of the UDI-DI, generated by the system rather than obtained from an issuing entity.
Is the November 27, 2026 EUDAMED registration deadline the same as the legacy device transition period that runs to 2027 or 2028?
No, and conflating them is the most common planning mistake. The November 27, 2026 date, set by MDR Article 123(3) and triggered by Commission Decision (EU) 2025/2371, is when EUDAMED registration and device data must be complete. The December 31, 2027 or December 31, 2028 dates, set by MDR Article 120(3a) as amended by Regulation (EU) 2023/607, are separate: they govern how long a device may keep being placed on the market under its old MDD or AIMDD certificate. A legacy device can be inside its market-placement extension and still be late on EUDAMED registration at the same time.
What data does a legacy device registration need that a new MDR device registration does not?
In place of a Notified Body certificate issued under the MDR, a legacy device registration carries the Directive-era certificate identification: the Notified Body number, certificate number, revision number, and expiry date, since legacy devices were not certified by a Notified Body under EUDAMED's MDR process. It does not need a UDI issuing entity selection, UDI medium or label marking data, or the Annex VI Part B technical dataset that is keyed to a Basic UDI-DI.
What happens when a legacy device later becomes MDR-compliant?
MDCG 2019-5 treats that as a new registration event, not an update to the legacy record. The now-MDR-compliant device must be registered with a Basic UDI-DI and UDI-DI as a new device. If a UDI-DI was already voluntarily assigned to the device while it was still registered as a legacy device, only the UDI-DI needs to be entered against the existing Basic UDI-DI rather than assigning both from scratch.
Is MDCG 2019-5 still valid guidance if it has been archived?
The Commission's document portal marked MDCG 2019-5 archived in December 2024, and the document itself is now stamped obsolete. That is a real caveat, not a formality: treat MDCG 2019-5 as historical background, not current authority, on its own. What still stands is the specific point MDCG 2021-25 Rev.1, the current guidance document dated October 2024, confirms in its requirements table by name-checking MDCG 2019-5: Article 27 UDI obligations do not apply to legacy devices. This guide relies on MDCG 2021-25 Rev.1 as the current authority and on MDCG 2019-5 only for the EUDAMED DI/EUDAMED ID mechanics that MDCG 2021-25 Rev.1's citation confirms are still the operative design.