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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

  • Guideline on good pharmacovigilance practices (GVP) Module III – Pharmacovigilance inspections (Rev 2)
  • Publication of COMBINE Project 2 Sponsors’ guide on safety reporting in combined studies
  • UK National Commission into the Regulation of AI in Healthcare
  • EMA Article 57 Q&A Version 1.15 (9 September 2026)
  • EMA guidance on Electronic product information (ePI) submission during centralised procedures
  • EU Medical Device Regulation (2017/745) and In Vitro Diagnostic Medical Device Regulation (2017/746) – Impact on international registrations. Middle East and Africa focus
  • IMDRF Document Implementation Report. 1 September 2026
  • EU Regulatory News : IVD Classification Rules – MDCG 2020-16 Rev.5

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