The question of when EUDAMED is fully functional has followed the medical device sector for years, through repeated delays and shifting timelines. The status is now clear and the answer has direct consequences for market access in the EU.
What the Commission Has Confirmed
On 27 November 2025, the Commission published Commission Decision (EU) 2025/2371. It confirmed that four EUDAMED modules are fully functional. This publication triggered a transition period of six months, meaning that as from 28 May 2026, the first four EUDAMED modules are mandatory to use.
The four modules declared functional are:
- Actor Registration – registration of economic operators
- UDI/Device Registration – registration of devices and Unique Device Identifiers
- Notified Bodies & Certificates – electronic information on certificates and related decisions
- Market Surveillance – support for competent authority activities
When Will EUDAMED Be Fully Functional Across All Six Modules?
EUDAMED consists of six modules: Actor Registration, UDI/Devices, Certificates/Notified Bodies, Clinical Investigations (for medical devices), Vigilance and Post-Market Surveillance, Market Surveillance, and Performance Studies (for IVDs). However, not all modules are currently available.
The two remaining modules are Clinical Investigations (MDR) and Performance Studies (IVDR), as well as Vigilance and Post-Market Surveillance. They have not yet been declared ready.
The four declared-functional modules, for practical compliance purposes, are the ones that matter now as of 28 May 2026.
Key Deadlines at a Glance
The following dates apply to manufacturers:
28 May 2026: Mandatory use begins
Mandatory use of the Actor Registration and UDI & Device Registration modules begins. Manufacturers must:
- Register as economic operators (obtaining a Single Registration Number SRN).
- Register all new devices placed on the EU market from this date onward.
28 November 2026: Legacy device registration deadline
Deadline for completing EUDAMED registration, including legacy devices placed on the market before 28 May 2026 that continue to be sold afterwards. This deadline applies to devices which were on the market before 28 May 2026 and will continue being placed on the market.
What “Mandatory” Means in Practice
EUDAMED is no longer optional. If an obligation is linked to one of the four modules, from 28 May 2026, it must be done in EUDAMED.
For non-EU manufacturers, registration must be verified by the EU Authorised Representative. The relevant Competent Authority then validates the registration and issues the SRN. After the actor registration, manufacturers can register their devices.
All EUDAMED data must match technical documentation, labelling, Instructions for Use, and certificates issued by the Notified Body. Inconsistencies can delay certification, trigger surveillance actions or disrupt communications with competent authorities.
Legacy Devices
Devices already on the market before 28 May 2026 that continue to be sold afterwards fall under specific transition rules. Registration in EUDAMED for these legacy devices must be completed by 28 November 2026.
Sources
European Commission – EUDAMED: four first modules will be mandatory to use as from 28 May 2026 (27 November 2025)
European Commission – EUDAMED: European Database on Medical Devices
MD Law – EUDAMED: functionality notice
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