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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

  • 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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