Registering Devices Already on the Market in EUDAMED by 27 November 2026

This document outlines the responsibilities of economic operators regarding the registration of 'legacy devices' in EUDAMED. It addresses the requirements for devices placed on the market under Directive 93/42/EEC (MDD), Directive 90/385/EEC (AIMDD), and Directive 98/79/EC (IVDD), which continue to be made available following the transitional provisions of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

#Understanding Legacy Devices and EUDAMED Registration

Legacy devices are those medical devices and in vitro diagnostic medical devices that can continue to be placed on the market or put into service under the transitional provisions of the MDR (Article 120) and IVDR (Article 110). These devices are subject to specific EUDAMED registration requirements, which differ from those for devices certified under the MDR or IVDR from their respective dates of application. Economic operators must ensure that all relevant data for these devices is accurately entered into EUDAMED by the stipulated deadlines.

#The 27 November 2026 Deadline

For legacy devices, a specific deadline for EUDAMED registration applies. All legacy devices, and certain devices placed on the market with an EC certificate under Directive 93/42/EEC (MDD) or Directive 90/385/EEC (AIMDD) that remains valid, must be registered in the EUDAMED Device and UDI module by 27 November 2026. This deadline is established by Article 123(3)(d) MDR, as amended by Regulation (EU) 2023/607, and Article 113(3)(d) IVDR, as amended by Regulation (EU) 2023/607, for devices that benefit from the transitional provisions. This date aligns with the full mandatory application of the Device and UDI module for all economic operators. It is crucial for distributors and importers to confirm the precise scope and application of this deadline with their national competent authority, as national interpretations or specific requirements may exist.

#Responsibilities of Economic Operators

While the manufacturer is primarily responsible for device registration in EUDAMED, other economic operators, such as authorised representatives, importers, and distributors, have related obligations. An economic operator with an existing Single Registration Number (SRN) must ensure they are prepared to verify and, where necessary, supplement the device data related to their activities.

#Manufacturers and Authorised Representatives

The manufacturer, or their authorised representative, is responsible for registering the device data and UDI-DI in EUDAMED. This includes information specified in Part A of Annex VI MDR/IVDR for the device itself, and in Part B of Annex VI MDR/IVDR for the UDI-DI. For legacy devices, this involves ensuring that the device's basic UDI-DI and UDI-DI, along with their corresponding data, are submitted to EUDAMED.

#Importers and Distributors

Importers must verify that the device has been registered in EUDAMED by the manufacturer before placing it on the market, as per Article 13(2) MDR and Article 13(2) IVDR. They must also ensure that the UDI is correctly assigned and present on the device or its packaging. Distributors similarly have an obligation to verify that the device is registered in EUDAMED, as per Article 14(2) MDR and Article 14(2) IVDR. These obligations extend to legacy devices. When a manufacturer fails to register a legacy device, an importer or distributor may need to inform their national competent authority. What changes for distributors and importers now that EUDAMED modules are mandatory provides further detail on these evolving responsibilities.

#Device and UDI-DI Records for Legacy Devices

For legacy devices, the manufacturer or authorised representative must enter the necessary device data into the EUDAMED Device and UDI module. This includes:

• Basic UDI-DI: The primary identifier of a device model. For legacy devices, this may be derived from existing product identification systems.
• UDI-DI: The specific identifier for a device's production model.
• Relevant device attributes: As detailed in Annex VI, Part A and B of the MDR/IVDR. This includes device nomenclature, risk class, intended purpose, and details of the EC certificate under the directives.

Manufacturers should also upload the relevant EC certificate issued under the MDD, AIMDD, or IVDD to EUDAMED, linking it to the device record. This demonstrates the legal basis for the device's continued marketing under the transitional provisions.

#Evidencing Completeness and Compliance

To evidence completeness and compliance with EUDAMED registration requirements for legacy devices, economic operators should maintain a systematic approach:

1. Manufacturer Confirmation: Manufacturers should provide confirmation of EUDAMED registration for all legacy devices to their importers and distributors.
2. Internal Procedures: Importers and distributors should establish internal procedures to verify the EUDAMED registration status of every legacy device they handle. This includes checking for the existence of the basic UDI-DI and UDI-DI in EUDAMED.
3. Documentation: Keep records of all verification checks and communications with manufacturers regarding EUDAMED registration.
4. National Competent Authority Guidance: Regularly consult the national competent authority for any specific guidance or national requirements concerning legacy device registration.

#Common Mistakes in Practice

• Assuming manufacturers have completed all registrations: Importers and distributors must actively verify registration status, not merely assume it.
• Incorrectly applying MDR/IVDR EUDAMED requirements to legacy devices: While registered in EUDAMED, legacy devices retain their MDD/AIMDD/IVDD compliance basis.
• Failure to account for device variants: Each UDI-DI, including those for different packaging configurations or sterile statuses, requires distinct registration.
• Not linking existing EC certificates: The validity of a legacy device's marketing depends on its existing certificate under the directives; this must be linked in EUDAMED.
• Delaying action until closer to the 27 November 2026 deadline: Proactive registration allows time to address data discrepancies or technical issues.
• Ignoring national competent authority specific guidance: Requirements can vary between Member States, impacting compliance for economic operators.

#Leveraging EUDAMED Data

Once registered, the data in EUDAMED facilitates market surveillance activities and traceability of legacy devices. For economic operators, EUDAMED serves as a central repository for device information, aiding in post-market surveillance activities and field safety corrective actions. Efficient access to and management of this data is key for maintaining compliance. The EUDAMED AI platform, as featured on eudamedai.com, provides tools that can assist in navigating and utilising the extensive data within EUDAMED, helping to manage regulatory information and monitor compliance obligations for legacy devices. Further details on how the platform can support your compliance efforts can be found at https://eudamedai.com/#platforma.

This material is for information only and is not legal advice. For binding interpretation consult your national competent authority.