The below information is provided based on the information available to the Commission services following a consultation of the Medical Device Coordination Group (MDCG) in October 2023.

Legacy devices that will be registered in EUDAMED will need two other unique access keys (IDs) to replace the Basic UDI-DI and UDI-DI for the sake of the workability of EUDAMED.

For this purpose, a EUDAMED DI will be assigned to the device instead of the Basic UDI-DI and a EUDAMED ID will be assigned by EUDAMED instead of the UDI-DI allowing the system to work and to keep the design of EUDAMED as close as possible to the MDR design. These EUDAMED DI and EUDAMED ID will be unique for a given legacy device.

Requirements to Register a Legacy device in UDI Module

Once this informationis entered in module, click on “Submit” to submit it directly or “Preview” to view before submitting: A pop-up window will appear asking you to confirm your submission. Once you confirm, you will be brought to a new window confirming the submission of your Legacy device.

Timeline for Submission

Currently, legacy devices should be understood as devices and are placed on the market after the MDR’s date of application -26 May 2021- and until 26 May 2024 if:

• They are class I devices, for which an EC declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure under the MDR requires the involvement of a notified body.
• They are devices covered by a valid EC certificate issued prior to 26 May 2021.

The registration of legacy devices in EUDAMED will be only required when the system will be fully functional and only in two particular cases:

• By the end of the transitional period (24 months after publication in the Official Journal of the European Union) if an equivalent device is not made compliant and registered as a MDR device by that date.
• In case of serious incident or field safety corrective action concerning a legacy device, such device must be registered in EUDAMED at the moment of the serious incident/field safety corrective action reporting in the Vigilance module. The Vigilance module will be available when EUDAMED is fully functional.

MDR addresses the possibility that EUDAMED is not fully functional on the date of application of the MDR (26 May 2021). Until EUDAMED is fully functional, the MDR stipulates that the corresponding provisions of Directives 90/385/EEC4 and 93/42/EEC5 shall continue to apply for the purpose of meeting the obligations regarding the exchange of information.

Alternative solutions to submit and/or exchange information (as required under the MDR)

1.Device Registration:

Manufacturers should refer to the national provisions in Member States establishing product registration schemes. Obligation of UDI assignment (Basic UDI and UDI-DI) to a device applies from 26 May 2021 and Labelling requirements apply gradually, starting from 26 May 2021.

2. Registration of manufacturers , authorised representative s and importers

Manufacturers, authorised representatives and importers should refer to the national provisions in Member States. Please refer to MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States.

3. Summary of safety and clinical performance

The SSCP shall be made available to the public upon request without undue delay or the manufacturer shall specify where it is made available to the public. As soon as the functionality is available in Eudamed, the system may be used for the upload of the SSCP even before the notice of full functionality of Eudamed has been published.

4. Certificate of Conformity

Certificates will be made available upon request or will be uploaded in the national system where required.

5. Application for clinical investigations

The application for clinical investigations should take place via the respective national procedures applicable to clinical investigations.

6. CircaBC Centre for Administrations, Businesses and Citizens)

The Commission has made available the list to Member States by means of a dedicated secure directory in the Communication and Information Resources Centre for Administrations, Businesses and Citizens (CircaBC). It is used for following purpose…

• Nomination of experts for joint assessment of applications for notification
• Changes to designations and notifications
• Involvement of notified bodies in conformity assessment procedures
• Clinical evaluation consultation procedure for certain class III and class IIb devices
• Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices
• Market surveillance activities