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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

  • Commission publishes guidelines on transparency obligations for providers and deployers of certain AI systems
  • MDCG Position Paper: UDI assignment between manufacturers and distributors
  • EMA Questions & answers on Article 31 non-pharmacovigilance referral procedures
  • EXTENSION OF THE MDR TRANSITIONAL PERIOD AND REMOVAL OF THE ‘SELL OFF’ PERIODS
  • MHRA Updated guidance for the International Recognition Procedure (IRP)
  • MDCG 2021-5 Rev. 1 .Guidance on standardisation for medical devices
  • Qualification of novel methodologies (QoNM) for medicinal product development . Procedural Guidance to applicants
  • FDA Guidance for Drug Development

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