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EUDAMED RoadMap

The EU Commission has today published a Draft EUDAMED RoadMap with updated timelines for each module and mandatory use dates.

Q4 2027: Actor, Certificates, MSU, Vigilance and CI/PS (MDR Article 123(3) (d) ) / (IVDR Article 113(3) (f))

Q2 2029: Devices and Certificates ((MDR Article 123(3) (e) ) / (IVDR Article 113(3) (a))

 

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eudamed roadmap

 

News & Trends

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Recentes

  • EMA’s ePI Roadmap
  • Sponsor Frequently Asked Questions Clinical Trial Information System (CTIS) Frequently Asked Questions (FAQs) on the Sponsor’s workspace
  • The new CTIS Sponsor Handbook (v6.2, March 2026)
  • New revision of the Q&A document on art. 10(a) interruption of supply published
  • IMDRF Technical Framework for Artificial Intelligence Life Cycle Management” (IMDRF AIML WG N93 – April 2026)
  • New Harmonised Standards under MDR – April 2026
  • EMA/CHMP: Updated Guideline on Active Substances published
  • Data Quality Framework for EU medicines regulation: application to Real-World Data

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