NEWS: EUDAMED State of Play: EU Commission delays EUDAMED Device Registration Go-live

by Francine Harris | March 23, 2021 | Blog

The EU Commission provides a “EUDAMED playground” available for both manual web-based user access and automated M2M (machine to machine) Data Exchange for Actor Registration, Notified Bodies & Certificates, and Device Registration modules.  These testing “playgrounds” are available in different rounds and for specific time periods with test cases for each version. 

Testing is critical to the success of EUDAMED, which is why Innovit remains an active participant and contributor in this process.  As a result, we wanted to provide a brief update on some recent changes.

The launch of the EUDAMED UDI/Device and Certificate registration modules was postponed from May 2021 to September 2021 (so no voluntary registration of devices is possible before this date in EUDAMED; only registration of Economic Operators).

  • There will be M2M Update/Patch service to be released in Sep 2021.  EU Commission (EUC) did not confirm whether this will be in the Playground or Production or both (to be confirmed over the coming months).  This means, however, that there will no M2M ability to test update/patch services prior to September (back in the MDCG on 24 November 2020, Innovit made the recommendation to escalate this feature for May 2022 release).  As a compromise, EUC has deferred the functionality for uploading Information and Container Package to later releases.
  • There will be no limit to the number of upload messages per day (at this time), but each message will be limited to a maximum of 300 records.
  • Both an updated Data Dictionary and updated Business Rule documentation will be available on March 19th.  It is currently unclear when updated XSDs will become available….  Click this link to read more on our LinkedIn EUDAMED forum!

Innovit understands today’s immediate challenges facing the medical device industry, so we welcome the EU Commission’s delay of its EUDAMED Device Registration module, which is expected to relieve pressure for key Medical Device manufacturers.  We’re here to assist and will proudly continue supporting our customers and partners to improve public health by increasing master data quality and delivering ‘trusted data’ for UDI compliance.

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