EUDAMED: Updated Guide to Legacy Device Registration Now Available

The European Commission has recently made available a new version of the Legacy device registration guide (Playground v3.11.0 - 2025) in the EUDAMED system, with detailed step-by-step instructions for manufacturers who still have devices placed on the market under the MDD or AIMDD directives.

This guide reinforces the need to comply with registration requirements for Legacy devices, in anticipation of the full entry into force of EUDAMED as a centralized and mandatory database under Regulation (EU) 2017/745.

What's important to know:

• Even without UDI-DI, Legacy devices will have to be identified with a new format: EUDAMED DI (prefix B-) and EUDAMED ID (prefix D-).

• Registration requires entering information about:

  • Valid certificates;

  • Device identification (EMDN, trade name, catalog number);

  • Technical characteristics, warnings and storage conditions;

  • Original manufacturer, if applicable;

  • Member States where the device is on the market;

• Legacy devices can be linked to regulated devices with the same UDI-DI, facilitating traceability and portfolio management.

Why is this relevant to manufacturers?

With the full EUDAMED obligation approaching, it is essential that Legacy devices are duly registered, even if they have not been placed on the market under the MDR. This registration:

• Guarantees the continuity of marketing;

• Facilitates audits and post-marketing surveillance;

• It strengthens transparency and trust with the competent authorities and end users.

See the full guide below.