The EU Commission seemed to have confirmed a delay to the mandatory implementation of EUDAMED by posting a new draft timeline to its website.
The draft timeline indicates that all six of the modules will not be in a position to undergo independent audits before Q4 of 2026, this is primarily due to the Clinical Investigations and Performance Studies Module. Furthermore, the audit is expected to be successfully completed by Q2 of 2027. After the successful audit, use of EUDAMED will be published in the Official Journal of the EU.
As from Q2 of 2027:
- There will be a 6-month transition period for the Actor, Vigilance, Market Surveillance, and Clinical Investigation and Performance Studies modules, becoming mandatory in Q4 of 2027, as per Article 123 (3) (d) MDR/113 (3) (f) IVDR.
- There will be a 24-month transition period for the UDI/Device Registration and Notified Body and Certificates Modules, becoming mandatory in Q2 of 2029, as per article 123 (3) (e) MDR/113 (3) (a) IVDR.
The full timeline published by the EU Commission can be accessed using the following link Are you ready for the mandatory implementation of EUDAMED? Visit Medilink member Advena’s website to learn more about how they can help you prepare for the upcoming changes.
