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EUDAMED ACTOR MODULE FAQs

ACTOR MODULE FAQs
November 2020 v1.0

Table of Contents

1. Countries available in EUDAMED from December 2020
2. Actor registration process
3. SRN
4. Actor roles
5. EUDAMED users
6. Support
7. Data Exchange

News & Trends

Procurar

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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