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  • Certificates (Active, suspended, reinstated, withdrawn, refused, other restrictions on certificates),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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Draft EUDAMED Roadmap of Modules