EUDAMED timeline: actor and device registration

With the EUDAMED notice published on 27 November 2025, the European database becomes officially mandatory. While the database has six modules, the four following modules are now declared functional:

• ACT/Actor module
• UDI/Device module
• Notified Bodies and Certificates
• Market Surveillance module

EUDAMED actor module: manufacturers to register by 28 May 2026

By 28 May 2026, all economic operators have to be registered in the ACT (actor) module. This includes manufacturers, authorised representative, sponsors of clinical investigations and performance studies, importers, system and procedure pack producers. For custom-made devices, only manufacturers of custom-made class III implantable devices have to register as actor. With regard to custom-made devices, the following applies:

• Manufacturers of only custom-made class III implantable devices must register in the ACT module to allow the Notified Body to register the corresponding QMS Certificate
• Manufacturers of only custom-made devices must register in the ACT module before they submit to EUDAMED related information concerning vigilance or PMS

Registration in the ACT module allows economic operators to receive the SRN (Single Registration Number), a unique identifier assigned to economic operators. Manufacturers of only custom-made devices will instead receive an Actor ID, an identifier similar to the  SRN.

Importantly, manufacturers located outside of the Union market require their authorised representative’s approval to finalise the registration.

EUDAMED device module: devices to register by 28 May 2026 or by 28 November 2026

When a Regulation device is placed on the market after or as of 28 May 2026, the manufacturer has to register this device before the first individual unit is placed on the EU market starting from 28 May 2026.

In case the first unit of a legacy device or Regulation device has been placed on the EU market before 28 May 2026, the manufacturer has to register their device by 28 November 2026.

Legacy and Regulation devices no longer placed on the market from 28 May 2026 do not need to be registered, unless a post-market surveillance or vigilance action occurs.

Do you have any questions on how to register on EUDAMED? Contact us here or at mdlaw@obelis.net.