Three New European Harmonized Standards Under the MDR
7 April 2026
MDCG 2021-24: ‘Guidance on Classification of Medical Devices’ Updated
20 April 2026Background
The following modules of EUDAMED, the European database on medical devices, become mandatory starting 28 May 2026:
- Actor
- UDI/Devices
- Notified Bodies & Certificates
Devices that were already on the market prior to 28 May 2026 have a further 6-month transition period, i.e., must be registered no later than 28 November 2026.
The Update
The Commission is hosting “all-day web-streamed” EUDAMED trainings over the next three weeks. More information, including links, is available: HERE
Below are the days and times for each training:
- Actor module: 28 April 2026 – 9:00-18:00 CEST
- UDI/Devices module: 5 May 2026 – 9:00-18:00 CEST
- Notified Bodies & Certificates module: 7 May 2026 – 9:00-18:00 CEST
At the moment, there is no additional information regarding the scope, e.g., if it is a one-hour training conducted at the start of each hour. We presume further details will be provided later and will update this post as needed.
