EUDAMED User Guide for Legacy Devices - Essential Tool for Compliance with European Regulations

The new version of the EUDAMED User Guide dedicated to the registration of Legacy Devices is available, an essential tool for manufacturers and legal representatives who want to ensure compliance with the European legal framework during the transition period from MDD/AIMDD to MDR.

Legacy devices refer to medical devices that remain on the market under the previous directives (Directive 93/42/EEC and Directive 90/385/EEC), but are not yet fully registered under the requirements of Regulation (EU) 2017/745.

This guide provides practical guidance on:

• The identification structure of legacy devices through the EUDAMED DI (equivalent to Basic UDI-DI) and EUDAMED ID (equivalent to UDI-DI) codes;

• The complete process of registering legacy devices with EUDAMED, with or without a previously assigned UDI;

• The insertion of technical data, certificates, device characteristics, marketing information and data from the original manufacturer;

• The connection between legacy devices and regulated devices, based on the same UDI-DI, guaranteeing traceability and continuity of information;

• Integrated management of legacy devices through the EUDAMED interface.

This document also clarifies the types of certificates valid for legacy devices, as well as the accepted identification formats, allowing organizations to structure their submission processes with greater confidence and security.

Important: The submission of legacy devices in EUDAMED is optional, but strongly recommended to strengthen traceability and ensure data consistency during the regulatory transition period.

See the full guide below.