Eudamed update

According to the Eudamed webpage, a significant upgrade will be installed over the period from 30 September and 4 October 2021, and users are advised not to try and access the system during this time, but to wait until a confirmation of upgrade completeness is published on the same webpage. The notice warns that the system may “appear active and inactive at times, yet it will be unstable and any work made in the system in this period might be lost.”

It is anticipated that completion of this upgrade will coincide with the availability of two new modules that were originally scheduled for release in May 2021, these being for unique device identification (UDI) data/device registration, plus notified bodies and certificates issued. Until the full Eudamed system is operational, entry of data to the system will remain voluntary.

Should this information be correct, then three of the six Eudamed modules will then be available for use by manufacturers, authorised representatives, importers, competent authorities and notified bodies. The Commission has indicated that the module sections for the ‘scrutiny’ mechanism and the clinical evaluation consultation procedure are not expected to be functional until May 2022.

The final three modules for clinical investigations/IVD performance studies, vigilance/post-market surveillance, and market surveillance, are also scheduled for completion in May 2022. If this date is achieved, and a notice is published in the Official Journal to that effect, use of Eudamed will become mandatory six months after the date of publication.