Legacy Devices play a central role during the transition period between the MDD/AIMDD and the MDR. These products may continue to be made available on the European market under certain conditions, even though they are not yet fully certified under the MDR.
The transitional provisions provide manufacturers with valuable additional time to complete MDR conformity assessments. However, they also introduce specific obligations. Requirements relating to Post-Market Surveillance (PMS), vigilance, clinical evidence, and EUDAMED registration must also be considered for Legacy Devices. At the same time, there is often uncertainty in practice regarding which rules apply, when registration is required, and how the transition to an MDR-compliant Basic UDI-DI and UDI-DI should be managed.
In this article, you will learn what constitutes a Legacy Device under the MDR, which requirements apply to manufacturers, which deadlines must be observed, and how EUDAMED registration works during the transition period.
Definition according to MDCG 2021-25
“Legacy devices” are devices placed on the market after the MDR date of application, in accordance with Article 120(3) MDR and under the conditions laid down therein, until 26 May 2024.
Devices that were Class I under Directive 93/42/EEC (MDD), for which a declaration of conformity was drawn up before 26 May 2021 and for which the conformity assessment procedure under the MDR requires the involvement of a notified body.
Devices covered by a valid EC certificate issued before 26 May 2021 under Directive 90/385/EEC (AIMDD) or Directive 93/42/EEC (MDD).”
Note: The dates referenced in MDCG 2021-25 are no longer up to date, as the transition timelines for Legacy Devices have been extended. The current deadline for the registration of Legacy Devices in EUDAMED is 28 November 2026.
Until when must Legacy Devices be MDR certified?
The certification deadlines for Legacy Devices depend on the product category. Until the deadlines listed below, devices may continue to be placed on the market based on their existing certificates. After these deadlines, MDR certification will be required for any newly placed product.
| Product Category | MDR Certification Deadline |
|---|---|
| Class III devices and implantable Class IIb devices (except certain implantable products such as screws, plates, clips, etc.) | 31 December 2027 |
| Other Class IIb devices, Class IIa devices, and Class I devices placed on the market in a sterile condition or with a measuring function | 31 December 2028 |
| Devices that were self-certified as Class I under the MDD but require notified body involvement under the MDR due to reclassification into a higher risk class | 31 December 2028 |
What is the difference between Legacy Devices and MDR Devices?
During the MDR transition period, Legacy Devices benefit from certain regulatory exemptions compared to MDR-certified products. They may continue to be marketed under the transitional provisions based on their MDD or AIMDD conformity, without yet being fully MDR certified. Full MDR conformity assessment becomes mandatory only when transitioning to MDR compliance.
Legacy Devices are also subject to specific EUDAMED registration requirements. While MDR-compliant devices are registered using a Basic UDI-DI and UDI-DI, Legacy Devices are registered using a EUDAMED-DI.
With regard to Post-Market Surveillance (PMS) and vigilance activities, however, Legacy Devices are subject to largely the same obligations as MDR devices. Manufacturers must monitor the safety and performance of their products after they have been placed on the market and maintain the PMS documentation required for the respective risk class.
Furthermore, manufacturers must be able to demonstrate sufficient clinical evidence when transitioning to the MDR. For MDR-certified devices, clinical evidence is required before market placement and is continuously supplemented through PMS activities thereafter.
How do I register a Legacy Device in EUDAMED?
The registration process for Legacy Devices differs from that of MDR-certified products. Legacy Devices are registered without a Basic UDI-DI. Instead, they receive a EUDAMED-DI.
Originally, the registration deadline was set at 18 months after the MDR date of application, provided that EUDAMED had become fully functional by then. Under the current timeline, Legacy Devices must be registered with their UDI-related data in EUDAMED by 28 November 2026.
However, if a serious incident or field safety corrective action (FSCA) occurs during the transition period, registration must be completed immediately. This requirement also applies to Legacy Devices that were already on the market before the MDR date of application but are no longer actively distributed.
A similar definition of Legacy Devices under the IVDR can be found in MDCG 2022-8.
For Legacy Devices, manufacturers must provide certificate information during device registration. In contrast, MDR device certificates are managed through the EUDAMED Notified Bodies and Certificates module, where certificate data is entered by the notified body pursuant to MDR Article 56(5).
What is the difference between UDI-DI and EUDAMED-ID?
For Legacy Devices, there is no Basic UDI-DI as defined under the MDR. Instead, EUDAMED assigns a EUDAMED-DI, which serves as the equivalent identifier for device registration purposes. This identifier is prefixed with “B-” and effectively fulfils the role that the Basic UDI-DI has for MDR-certified devices.
A Legacy Device may already have a UDI-DI issued by a recognised issuing entity, such as a GS1 GTIN. In this case, the manufacturer must provide this existing UDI-DI during registration, and EUDAMED generates the corresponding EUDAMED-DI based on that identifier.
Only where no UDI-DI from an issuing entity exists for the Legacy Device can the manufacturer generate an EUDAMED-ID. In this scenario, the EUDAMED-ID is constructed from the manufacturer’s Single Registration Number (SRN), a numerical sequence, and a check digit. The EUDAMED-ID is prefixed with “D-” and can be used for registration of Legacy Devices that do not already have a UDI-DI assigned by an issuing entity.
Consequently, the EUDAMED-ID does not generally replace the UDI-DI. Rather, it serves as an alternative identifier that is available only when no UDI-DI issued by a recognised issuing entity has been assigned to the Legacy Device. In practice, many manufacturers already assign UDI-DIs to their Legacy Devices because these products are often expected to transition to MDR-compliant devices in the future, where a UDI-DI is required.
What are the benefits of tracekey solutions’ UDI registration software for medical device manufacturers?
Just as with newly certified medical devices, tracekey supports manufacturers in registering their Legacy Devices in EUDAMED in compliance with MDR requirements.
A structured Excel import into the tracekey system allows manufacturers to identify missing product information required for EUDAMED registration. The data is then automatically validated, and once completed correctly, it can be submitted directly to EUDAMED via either our M2M interface or XML bulk upload.
This process helps prevent submission errors and ensures compliance with EUDAMED business rules. Data exchange is fully automated and takes place directly between the systems.
Another key advantage is comprehensive documentation, including proper version control and a complete audit trail.
tracekey solutions supports manufacturers with the mytracekey UDI Manager for registering UDI data in EUDAMED and other databases. To learn more about the process, please join one of our software demonstrations. You can register for a demo session free of charge and without obligation.
FAQ: Legacy Devices, UDI, and EUDAMED Registration Under the MDR
A device remains in “Draft” status within EUDAMED until the data record has been finally submitted and published. Saving a draft alone does not constitute a completed registration. Manufacturers should therefore ensure that all required data is submitted in full and on time. For compliance with regulatory deadlines, successful registration is decisive, not draft status.
During the transition period, it is possible for both MDD/AIMDD Legacy Devices and MDR-certified versions of the same product to coexist on the market. In such cases, the different regulatory product versions must be considered separately within EUDAMED. Whether parallel registration is required depends on the certification status and regulatory situation of the specific product.
When a previously registered Legacy Device obtains MDR certification, the device must be registered under the MDR-compliant UDI structure. This involves creating a Basic UDI-DI and UDI-DI for the MDR-certified device. The existing Legacy Device registration is not converted but supplemented by the new MDR registration.
A Legacy Device is a medical device that was originally certified under the MDD or AIMDD and may continue to be placed on the market under the MDR transitional provisions. While it does not yet hold an MDR certificate, it may still be marketed subject to specific conditions.
Dual registration may be necessary when a product is transitioning from MDD/AIMDD certification to MDR certification and both Legacy and MDR-certified product versions are simultaneously available on the market. The exact registration obligations depend on the specific regulatory circumstances.
Once a product is marketed entirely under an MDR certificate, registration is generally carried out using a Basic UDI-DI and UDI-DI in accordance with the MDR. Whether an existing Legacy Device registration remains relevant depends on whether Legacy Devices are still present on the market or within the supply chain.
Products that were originally registered using only a EUDAMED-DI can subsequently be migrated to the MDR-compliant UDI structure. In this case, the required Basic UDI-DI and UDI-DI information must be added and registered in accordance with MDR requirements.
The EUDAMED-DI was specifically introduced for Legacy Devices. MDR-compliant devices are registered using the Basic UDI-DI and UDI-DI. Manufacturers should assess whether their products still fall under the Legacy Device provisions or whether MDR registration is required.
If a product is initially registered as a Legacy Device and later receives an MDR-compliant UDI, EUDAMED allows a linkage between the Legacy Device data record and the MDR product record. This ensures that the regulatory history remains traceable and the transition is documented transparently.
No. Legacy Devices are generally registered without a Basic UDI-DI. Instead, registration is based on the EUDAMED-DI. The Basic UDI-DI and UDI-DI become relevant only once the product is registered under the MDR.
No. When a product transitions to MDR certification, the relevant UDI identifiers must be created and registered separately. A Legacy Device data record cannot simply be converted into an MDR data record.
Also of interest
What requirements must a medical device meet under the MDR in order to be placed on the market? Learn more about the obligations of manufacturers, importers, and authorised representatives.
[Disclaimer]
The information provided herein represents one possible interpretation of the applicable regulatory requirements. As the regulatory framework continues to evolve, the information contained in this article may become incomplete or outdated. This article does not constitute legal advice. Manufacturers should always consult the applicable legislation, guidance documents, and official sources before making business or regulatory decisions.
Information status: October 2026