What is the status of EUDAMED today?
This is a good question.
We are only months from the new EUDAMED implementation date; however, half of the EUDAMED modules are still not released. And, the EU Commission has been noncommunicative about next steps for EUDAMED.
Interestingly, the EU Commission quietly uploaded a new ‘EUDAMED Time line’, with a new fully functional date of Q2 2023, and mandatory date of Q2 2025. No (obvious) official statement from the EU Commission was published about this new timeframe; instead, it appears to have been quietly uploaded.
If correct, this pushes the date out again by another year.
Swissmedic
has also made pointed comments about EUDAMED’s release date in their documents, such as the following in their Information Sheet ‘Procurement of medical devices in health institutions’:
“The Commission has repeatedly delayed full implementation. As far as we are aware at present, EUDAMED will be available at the end of 2022.”
The ‘end of 2022’ date is in line with the EU Commission’s new Timeline chart, which shows all six modules as being released by Q4 2022. After that, an independent audit of the system must occur. If the audit is successful, EUDAMED will be considered fully functional and be published in the Official Journal of the European Union. This then starts the six month transition period.
In the meantime, the EU Commission has been releasing modules on a voluntary use basis and has encouraged industry to start using the system early.
The following modules are available for voluntary use today:
-
- Actor
registration
- UDI/Devices registration
- Notified Bodies and certificates
The following modules are still in development and needed for EUDAMED to be fully functional:
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- Clinical investigations and performance studies
- Vigilance and post-market surveillance
- Market Surveillance