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Data Integrity — Frequently Asked Questions (FAQ). Version 3

This document contains a collection of frequently asked questions that have been submitted by the industry to the DI taskforce.

The intention of this documents is that this is a living document that will be updated as new questions are opposed to the group.

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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