Currently, among the EUDAMED modules, the Actor, UDI/Device, and Notified Bodies and Certificates modules are already available for use. On 27 November 2025, a notice was published in the Official Journal of the European Union (OJEU) announcing that the use of four modules – Actor, UDI/Device, Notified Bodies and Certificates, and Market Surveillance – will become mandatory as of 28 May 2026.
EUDAMED is the European database on medical devices that collects and shares information on medical devices and in vitro diagnostic medical devices.
This system supports early action and timely regulatory compliance, and currently the following registrations in EUDAMED are required.
- Actor registration: Manufacturers, importers, and authorized representatives must register as Actors.
- Device registration: Manufacturers must register their medical devices in order to comply with the medical device regulations.
EUDAMED consists of six interconnected modules, each supporting a specific function, as outlined below.
1) Actor
2) UDI/Device
3) Notified Bodies and Certificates
4) Post-Market Surveillance Vigilance
5) Market Surveillance
6) Clinical Investigations/Performance Studies
Following the publication of the notice in the OJEU on 27 November 2025, a six month transitional period has commenced. As of 28 May 2026, the following EUDAMED modules will become mandatory.
1) Actor
2) UDI/Device
3) Notified Bodies and Certificates
4) Market Surveillance
Please refer to the link below.
If you have any questions about medical devices,
please contact us with the below.
ra@jnmglobal.net
info@jnmglobal.net