[Emergo, UL] Search Functions in the European Medical Device Database EUDAMED
As a sequel to our recent update on searches that can be performed in the U.S. FDA 510(k) database, Emergo by UL reports on medical device searches in the European database for medical devices, EUDAMED, with the device registration data that has already voluntarily been included.
The European Medical Devices Regulation 2017/745 (MDR) and the European In Vitro Diagnostic Device Regulation 2017/746 (IVDR) introduced the publicly accessible European database for medical devices, EUDAMED. While the ACTORS Module was first released for voluntary use on December 1, 2020, to facilitate the application for Single Registration Numbers (SRN), EUDAMED and the six modules have been delayed. In 2024, Regulation 2024/1860 revised the legislative requirement that all modules be released at the same time.
Resources from the European Commission (EC) exist to support EUDAMED: Information Centre, Q&A document (November 2024, and an infographic (with timelines). Most recently, the EC hosted a one-day workshop (May 21) and will host additional workshops.
To date, there is no official date for when certain EUDAMED modules will become compulsory.
Search Functions in the European Medical Device Database EUDAMED | Emergo by UL
Search Functions in the European Medical Device Database EUDAMED
As a sequel to our recent update on searches that can be performed in the U.S. FDA 510(k) database, Emergo by UL reports on medical device searches in the European database for medical devices, EUDAMED, with the device registration data that has already vo
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