From 28 May 2026, it will be mandatory to use the first four modules of the European Database on Medical Devices.
The Commission Decision (EU) 2025/2371, published on 27 November 2025, confirms the full functionality of the first four EUDAMED modules.
From 28 May 2026, use of the following modules will therefore become mandatory.
• Actors: for the registration of economic operators.
• UDI/Device registration: for registering medical devices with the exception of custom-made devices.
• Notified Bodies and Certificates: for the registration of notified bodies and certificates.
• Market Surveillance: for coordinating market surveillance actions between the different competent authorities.
The Vigilance and post-market surveillance and Clinical Investigations and performance studies modules will be implemented at a later date.
Obligations in force from 28 May 2026
• Actors module:
As of 28 May 2026, all manufacturers, agents, importers and producers of systems and procedure packs will have to be registered in EUDAMED's Actors module.
• UDI/Devices module:
An additional period of six months (between 28 May 2026 and 27 November 2026) is foreseen for the registration of devices to enable manufacturers to encode all the devices concerned. This transitional period applies only to in vitro diagnostic medical devices placed on the market before 28 May 2026. Those placed on the market after this date will have to be registered before being placed on the market.
Until 28 May 2026
National requirements will continue to apply until 28 May 2026. The placing on the market of a class I medical device or an in vitro diagnostic medical device must always be notified to the FAMHP (up to and including 27 May 2026), except when the device has already been voluntarily registered in EUDAMED, which is considered equivalent to a notification.
The FAMHP strongly recommends carrying out the necessary registrations in the Actors and UDI/devices modules as soon as possible.
More information
Eudamed