European Legislation Published for First Four Modules of EUDAMED

By Beth Pugh, Evan Ruby and Evangeline Loh

Progress has been made on the European database EUDAMED. The drafters of Regulation 2017/745 and Regulation 2017/746 for the Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR), respectively, originally envisioned the release of all six modules at the same time. After tremendous delays, it became clear that this was not a tenable proposition. Regulation 2024/1860 amended the MDR and IVDR to permit the release of the EUDAMED modules as they were verified as functional. 

Commission Decision 2025/2371

The eagerly anticipated legislation, Commission Decision (EU) 2025/2371, announcing compulsory use of some EUDAMED modules, was published on November 27. Decision 2025/2371 is succinct, comprising six recitals and two articles. 

Recital 4 explains that the independent audit report was completed on June 18.

Deadlines for EUDAMED

For new MDR- and IVDR-compliant devices placed on the market from May 28, 2026, registration in four modules (Article 1) will be mandatory: Actor Registration (ACT) (Article 1(a)), UDI/Device Registration (UDI/DEV) (Article 1(b)), Notified Bodies and Certificates (NB/CRF) (Article 1(c)), and Market Surveillance (MSU) (Article 1(d)).

For MDR- and IVDR-compliant devices placed on the market before that date, manufacturers have until November 27, 2026 to register in UDI/DEV. Still, such manufacturers must register in ACT no later than May 28, 2026. Devices that are exempt from registration in UDI/DEV but are the subject of a post-market surveillance/vigilance (PMSV) submission (PSUR, MIR, FSCA, or Trend reports) after the Vigilance Module becomes mandatory must first be registered in EUDAMED before the submission. 

What you need to know

This legislation requires the use of four EUDAMED modules. As of May 28, manufacturers of new devices will be required to comply, and for devices placed on the market before this date, manufacturers have until November 27.

Emergo experts continue to monitor regulatory developments. The legislation facilitates public information about devices registered in Europe.