Legacy device registration in EUDAMED: importer and distributor duties

This article outlines the obligations for importers and distributors regarding legacy devices within the European Union. It focuses on the specific requirements for registration in EUDAMED and the critical deadlines involved. Compliance officers and quality managers must ensure these duties are understood and implemented to avoid market access disruptions.

#Understanding Legacy Devices and their Market Status

Legacy devices are defined as medical devices or in vitro diagnostic medical devices (IVDs) placed on the market under the Medical Device Directives (93/42/EEC and 90/385/EEC) or the In Vitro Diagnostic Medical Device Directive (98/79/EC), which continue to be made available on the EU market after the dates of application of the Medical Device Regulation (MDR, Regulation (EU) 2017/745) and the In Vitro Diagnostic Medical Device Regulation (IVDR, Regulation (EU) 2017/746). These devices benefit from transitional provisions allowing their continued marketing, subject to certain conditions.

For a device to be considered a legacy device, it must hold a valid certificate issued under the Directives before 26 May 2021 (for MDs) or 26 May 2022 (for IVDs), and that certificate must remain valid. Furthermore, the device must continue to comply with the Directives, and there must be no significant changes in its design or intended purpose. The post-market surveillance, market surveillance, vigilance, and registration of economic operators and devices for these products must comply with the requirements of the MDR or IVDR, as applicable. For more details on device registration deadlines, refer to Registering Devices Already on the Market in EUDAMED by 27 November 2026.

#EUDAMED Registration Obligations for Importers and Distributors

EUDAMED, the European Databank on Medical Devices, serves as the IT system developed by the European Commission to implement the MDR and IVDR. It comprises various modules for different aspects of medical device regulation. While EUDAMED is not yet fully mandatory for all modules, certain aspects have become operational and carry obligations for economic operators.

#Economic Operator Registration

Importers and distributors have specific duties regarding their own registration in EUDAMED. As per Article 31(1) MDR and Article 28(1) IVDR, importers, and where applicable, distributors (depending on national transposition and the specific EUDAMED module status), must register in EUDAMED. This registration includes their contact details, location, and the type of economic operator they are. Upon successful registration, a Single Registration Number (SRN) is issued, which identifies the economic operator within EUDAMED. This SRN must be used in all correspondence and submissions to EUDAMED and is a crucial identifier for market surveillance purposes.

#Device Registration and UDI

For legacy devices, the manufacturer is primarily responsible for device registration in EUDAMED, including UDI data submission. However, importers and distributors play a critical role in verifying that these obligations have been met by the manufacturer. Article 13(2) MDR and Article 11(2) IVDR state that before placing a device on the market, importers must verify that the manufacturer has assigned a UDI to the device. While this applies to new devices, for legacy devices, importers and distributors should ensure the manufacturer has taken necessary steps for identification consistent with the UDI principles. The specific deadlines for legacy device registration in EUDAMED for manufacturers, and consequently the information that importers and distributors must verify, have been outlined by the European Commission, with a current deadline of 27 November 2026 for UDI/device registration of legacy devices. Readers should confirm the current status and scope of these requirements with their national competent authority.

#Data Verification and Retention

Importers and distributors must maintain robust internal processes to verify compliance. Article 13(2) MDR and Article 11(2) IVDR stipulate that importers must verify that the device has been registered in EUDAMED by the manufacturer. This verification extends to ensuring the UDI information, once available for legacy devices in EUDAMED, is consistent with the devices they are placing on the market. Distributors have similar verification responsibilities under Article 14(2) MDR and Article 12(2) IVDR, including checking that the device bears the CE marking and that the manufacturer and, where applicable, the importer have fulfilled their obligations.

Evidence of these checks, including records of manufacturer SRNs, device UDI-DIs (if available and relevant for legacy devices), and confirmation of EUDAMED registration status, must be retained for potential inspection by competent authorities.

#Deadlines and Transitional Provisions

The implementation of EUDAMED modules has been staggered. While the Economic Operators, UDI/Devices, and Certificates modules are functional, their mandatory use dates depend on the full functionality and auditing of EUDAMED as a whole. The European Commission has confirmed that the UDI/Device registration module must be used for legacy devices by 27 November 2026. This deadline applies to manufacturers. Importers and distributors must therefore be prepared to verify this information from the manufacturer and ensure their internal systems can handle this data.

The specific requirements and their mandatory application dates for importers and distributors may vary depending on the particular EUDAMED module and national competent authority guidance. It is imperative to consult the latest guidance from the European Commission and relevant national authorities. For an overview of how EUDAMED's mandatory modules affect distributors and importers, please see What changes for distributors and importers now that EUDAMED modules are mandatory.

#Evidence to Retain for Market Surveillance

Market surveillance authorities require economic operators to demonstrate compliance. Importers and distributors must retain comprehensive records. The following table summarises key evidence points:

| Type of Evidence | Description | Relevant Regulation Article |

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