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Medical Devices: Post Market Surveillance National Competent Authority Report Exchange Criteria and Report Form

This document provides guidance on:

• the criteria to be used for deciding when to exchange information,
• the procedures to follow when exchanging information,
• the forms to use for exchanging information,
• the requirements for IMDRF members participation in the NCAR Exchange Program.

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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