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MDCG NEWS!
MDCG 2024-3 – Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices (March 2024)
This guidance document has been written to support sponsors developing their Clinical Investigation Plan (CIP) by describing in greater detail what type of information is expected in the respective CIP sections, to pre-empt questions from the competent authorities during the assessment of the clinical investigation application. Moreover, a CIP with the appropriate content will be instrumental in the conduct of the clinical investigation.
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