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MDCG releases new and updated guidance documents
- 19 April 2024
- Posted by: inetika
- Category: GLOBAL NEWS
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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.
