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    Clinical Investigation Plan

    EU MDR's term for the protocol document governing a clinical investigation of a device.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    ISO 14155 and MDR Annex XV define the required content of the CIP - objectives, design, statistical considerations, ethical considerations, monitoring, and reporting. Functionally analogous to a U.S. clinical investigation protocol.

    What this means in practice

    Sponsors running global trials typically maintain a single harmonized CIP/Protocol with regional appendices for FDA, MDR, and other regulators.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISO·1FDA·1NIH·1
    1. 1
      ISO 14155
      Verified
      ISOiso.org
    2. 2
      FDA - Clinical Trials and Human Subject Protection
      Verified
      FDAfda.gov
    3. 3
      ClinicalTrials.gov
      Verified
      NIHclinicaltrials.gov

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