Clinical Investigation Plan (CIP)

A Clinical Investigation Plan (CIP) is any systematic investigation of a medical device that involves one or more human subjects. The CIP describes the rationale, objectives, design methodology, monitoring, conduct, record-keeping and the method of analysis for a clinical investigation. Requirements for the CIP are detailed in Annex XV (Chapter II, Section 3) of the Medical Devices Regulation (2017/745).


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“The Emtex medical writing team exceeded my expectations in their development of a series of Risk Management Plans. I was very impressed with their expertise.”

Director Medical Writing

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