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Notified Bodies Survey on certifications and applications(MDR/IVDR) MDCG & Stakeholders 24 Oct 2022

EU MDR/IVDR News! (certifications and applications)

Notified Bodies Survey on certifications and applications(MDR/IVDR)
MDCG & Stakeholders 24 Oct 2022

 

General data of Notified bodies replies received – October 2022

Slides 6 & 7 describes well the state of play related to MDR applications and certificates issued.

News & Trends

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Recentes

  • FDA Examples of Real-World Evidence Used in Medical Device Regulatory Decisions
  • FDA eMDR – Electronic Medical Device Reporting
  •  ACT EU Draft Guidance on Clinical Trials During Public Health Emergencies
  • 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)

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