The European database on medical devices has moved from “coming soon” to “required now”. Since May 2026, the first EUDAMED modules are mandatory — and registration is the gateway to everything else.
EUDAMED is the EU’s central database for medical devices, designed to bring transparency and traceability across the single market. After years of phased development, a Commission Decision of November 2025 declared the first four modules functional, which — under Regulation (EU) 2024/1860 — triggered a six-month transition making them mandatory from 28 May 2026.
The four mandatory modules
- Actor registration — manufacturers, authorised representatives and importers.
- UDI / device registration.
- Notified bodies and certificates.
- Market surveillance.
The Single Registration Number
Actor registration is the foundation. Each economic operator obtains a Single Registration Number (SRN), which is then required to register devices and certificates and is used throughout the system. Without an SRN, nothing else can proceed — so it is the first step for any operator active in the EU.
Still to come
Two modules — vigilance and post-market surveillance, and clinical investigations and performance studies — remain under development and are not yet mandatory. Current projections point to mandatory use around 2027, but no firm Commission date has been set, so treat those timelines as provisional.
Simplification in progress
In December 2025 the Commission proposed a targeted revision of the MDR and IVDR to cut complexity and cost, particularly for smaller companies — covering revised software rules, wider electronic instructions for use, and new pathways for orphan and breakthrough devices. It is a proposal working its way through the legislative process, not yet law.
How PQRA helps
PQRA handles actor registration and SRN applications, device and certificate registration, and ongoing EUDAMED obligations.
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