EUDAMED Mandatory Use Starts Today
May 28
Use of the EUDAMED 1) Actor, 2) UDI/Device, 3) Notified Bodies/Certificates, and 4) Market Surveillance modules come into force today.
All Actors must be regsitered in EUDAMED by today. Actors requiring registration in EUDAMED are Manufacturers, System/Procedure Pack Producers, Importers, and Authorized Representatives. Devices that were already on the market prior to today have a six-month transition period to comply with the UDI/Device registration module. Any new devices must be registered in EUDAMED prior to marketing.
Background:
- The use of the above four modules was published in the Official Journal of the EU (OJEU) on November 26, 2025.
- As of May 28, 2026 the implementing act formally went into force. After this date, any device new to the European market must be registered in the UDI/Device module prior to marketing. And any certificates issued on or after today must be uploaded immediately into the Notified Body/Certificates module. Devices already on the market before this date have a transition period.
- As of November 28, 2026 the transition period ends. All devices that were on the European market before May 28, 2026 must be registered in EUDAMED by this date. If not, the device will be out of MDR / IVDR compliance.
- As of May 28, 2027 Notified Bodies must upload certificates into the Notified Bodies/Certificates module.
For more detail, please read: EUDAMED Officially Published Today