In July 2022 the EU Commission pulished an updated EUDAMED timeline. The new ‘go live’ date is now Q2 2024. Read more about it: HERE
Originally, EUDAMED was to be fully functional on 26 May 2020, to align with the MDR’s original date of application. EUDAMED would then become mandatory on 26 May 2022, after a two-year transition period.
However, close to the May 2020 implementation date, the EU Commission delayed EUDAMED by two years. This pushed the fully functional date out to 26 May 2022 and the mandatory use date to 26 May 2024.
And, it now appears it may have been pushed out yet again.
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:
The following modules are still in development and needed for EUDAMED to be fully functional:
It appears it be delayed by another year, with a new implementation date of Q2 2023, and new mandatory date of Q2 2023 for some modules and Q2 2025 for the remaining modules.
Until EUDAMED is mandatory, industry should comply with the registration requirements outlined in the old Directives.
We presume the EU Commission will work hard to ensure that the new EUDAMED date is met. Otherwise, industry will be following the registration requirements of the old Directives – long after the MDD/AIMDD have any relevancy. MDD/AIMDD medical devices cannot legally be placed onto the EU market after 26 May 2024 and cannot be put into service after 26 May 2025.
