Draft EUDAMED roadmap (of modules*) was published on 20 Oct 2023 with updated timelines for each module and mandatory use dates for the MDR & IVDR.
Q4’ 2027: Article 123 (3) (d) MDR/113 (3) (f) IVDR
- Actor (Economic Operators register in EUDAMED; Supervising Entities has access to EUDAMED that is not public),
- Certificates (Active, suspended, reinstated, withdrawn, refused, other restrictions on certificates),
- MSU (Evaluation of devices on the market by Competent Authorities),
- Vigilance (& Post Market Surveillance), and
- CI/PS (Before a device is placed on the market – Clinical Investigation and Performance Study)
Q2’ 2029: Article 123 (3) (e) MDR/113 (3) (a) IVDR
- Devices (Based on UDIs registered in EUDAMED) and
- Certificates (see above)
* For a brief explanation of EUDAMED modules refer to the below
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