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MDCG releases new and updated guidance documents

  • Posted by: inetika
  • Category: GLOBAL NEWS

The European Medical Device Coordination Group (MDCG) has release several new or updated guidance documents over the past few weeks, including:

  • MDCG 2024-3 – Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices (March 2024)
  • Overview of language requirements for manufacturers of medical devices (March 2024)
  • MDCG 2024-4 – Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 (April 2024)
  • MDCG 2024-5 – Guidance on the Investigator’s Brochure content (April 2024)
  • Update – MDCG 2022-9 rev.1 – Summary of safety and performance template (April 2024)

Links to these guidance documents can be found on the Commission website.