What changes for distributors and importers now that EUDAMED modules are mandatory

The European Database on Medical Devices (EUDAMED) is being implemented in stages to enhance transparency and traceability for medical devices within the European Union. While certain modules have been voluntary, the full mandatory use of EUDAMED is approaching, with implications for all economic operators, including distributors and importers.

This document outlines the key changes and responsibilities for distributors and importers in light of EUDAMED's mandatory status, particularly concerning device registration verification.

#EUDAMED's Mandatory Use Timeline

EUDAMED was established under Article 33 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 30 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Its full functionality is being rolled out module by module. While some modules have been operational on a voluntary basis since 2021 and 2022, the European Commission has communicated a target date for the mandatory use of the Medical Devices and In Vitro Diagnostic Medical Devices EUDAMED modules for May 2026. This date is subject to the European Commission's declaration of full functionality and publication in the Official Journal of the European Union, as per Article 34(3) MDR and Article 31(3) IVDR.

Economic operators should monitor official communications from the European Commission and their national competent authorities for the definitive mandatory use date.

#Distributor and Importer Responsibilities Regarding EUDAMED

Distributors and importers have specific obligations under the MDR and IVDR. A core responsibility is to ensure that devices they place on the market comply with the relevant regulations. This includes verifying device registration status, which is directly impacted by EUDAMED.

#Verification of Device Registration

Before making a device available on the market, distributors and importers must verify several aspects of its conformity. Under Article 14(2)(a) MDR and Article 12(2)(a) IVDR, distributors must verify that the device has been CE marked and that the EU declaration of conformity has been drawn up. Similarly, Article 13(2)(a) MDR and Article 11(2)(a) IVDR require importers to verify that the device has been CE marked and that the EU declaration of conformity has been drawn up.

Crucially, once the module for device registration in EUDAMED becomes mandatory, this verification process will require direct consultation of the database. Economic operators must check that the device, and where applicable, its manufacturer and authorised representative, are registered in EUDAMED.

Specifically, Article 14(2)(d) MDR and Article 12(2)(d) IVDR stipulate that distributors shall verify, where applicable, that the manufacturer has assigned a UDI to the device. The UDI (Unique Device Identification) system, defined in Article 27 MDR and Article 24 IVDR, necessitates that devices are registered in EUDAMED. Therefore, verifying the UDI automatically links to EUDAMED consultation.

#Practical Implications for Verification Processes

For distributors and importers, the mandatory use of EUDAMED means an update to their standard operating procedures (SOPs) for incoming device checks. The process will likely involve:

1. Accessing EUDAMED: Establishing direct access to the public EUDAMED database.
2. Searching by UDI: Using the Basic UDI-DI (BUDI-DI) or UDI-DI to locate the device registration information.
3. Cross-referencing Data: Verifying the device's registration status, manufacturer details, and authorised representative information against documentation provided by the manufacturer.
4. Documentation of Verification: Recording the date and outcome of the EUDAMED check as part of the quality management system.

This verification step becomes an integral part of due diligence. Failure to perform these checks could result in non-compliant devices being placed on the market, leading to withdrawal or recall actions, as well as potential penalties. The specifics of these penalties are determined by national law, as exemplified by the Slovenian Agency for Medicinal Products and Medical Devices (JAZMP) outlining national enforcement measures.

#Record Keeping

Article 14(4) MDR and Article 12(4) IVDR require distributors to keep a register of complaints, non-conforming devices, recalls, and withdrawals, and to keep manufacturers, authorised representatives, and importers informed. Article 13(5) MDR and Article 11(5) IVDR impose similar record-keeping requirements on importers. The information obtained from EUDAMED checks, including evidence of verification, must be maintained as part of these records within the distributor's or importer's quality management system.

#Common mistakes in practice

• Relying solely on manufacturer declarations: Distributors and importers must not rely exclusively on the manufacturer's declaration that a device is registered. Direct verification in EUDAMED will become necessary.
• Delaying quality management system updates: Postponing the integration of EUDAMED checks into existing SOPs for goods inward and product release.
• Inadequate training: Failing to train relevant personnel on how to access and navigate EUDAMED for device verification.
• Insufficient record-keeping: Not documenting the EUDAMED verification process thoroughly, including search parameters, dates, and outcomes.
• Ignoring national specificities: Not checking with the national competent authority for any country-specific requirements or guidance regarding EUDAMED implementation.

#The Role of EUDAMED in Compliance

The table below illustrates the relationship between distributor/importer obligations and EUDAMED functionalities.

Distributors and importers should confirm the current status and scope of EUDAMED modules with their national competent authority, as the full mandatory implementation will occur in stages. For instance, in Croatia, the national competent authority, HALMED, provides guidance on EUDAMED registration requirements.

This digital transformation, while challenging, aims to enhance patient safety and market transparency. Tools such as the EUDAMED AI platform can assist economic operators in navigating this complex regulatory landscape by providing structured access to information and facilitating internal compliance processes. You can learn more at: https://eudamedai.com/#platforma

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