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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. The CIP covers the device description, endpoints, eligibility, sample size justification, follow-up schedule, adverse event handling, data management and the risk-benefit rationale. It must be approved by ethics committees and, where required, competent authorities before enrollment. Changes go through formal amendments, and the CIP forms the basis for monitoring, deviation assessment and the final clinical investigation report.
    What the regulation says
    The Clinical Investigation Plan (CIP) is a foundational document for clinical studies, as detailed in ISO 14155:2020 which specifies requirements for the conduct of clinical investigations of medical devices. The EU MDR, in Annex XV, also outlines the essential elements of a CIP to ensure the protection of subjects’ rights, safety, and well-being, and to guarantee the scientific validity of the investigation. The FDA refers to this document as a "protocol" and mandates similar content under its investigational device exemption (IDE) regulations, such as in 21 CFR 812.25.

    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.

    Examples

    • A MedTech company developing a novel vascular stent creates a CIP detailing the study population, inclusion/exclusion criteria, primary and secondary endpoints, and follow-up schedule for a pivotal clinical trial.
    • Before initiating a usability study for a new insulin pump, a manufacturer develops a CIP outlining the user tasks, evaluation criteria, and methods for collecting user feedback.
    • A sponsor conducting a post-market clinical follow-up (PMCF) study for a knee implant develops a CIP specifying the long-term patient monitoring, data collection points, and safety reporting requirements.
    Common pitfalls
    • •Failing to align the CIP with the Investigational Device Brochure (IDB) can lead to regulatory delays and ethical concerns.
    • •Inadequate statistical planning in the CIP can result in a study that is underpowered or unable to demonstrate its primary endpoints effectively.
    • •Not clearly defining stopping rules or adverse event reporting procedures within the CIP can jeopardize patient safety and regulatory compliance.
    • •Overlooking the need for regional appendices in the CIP for multi-national trials can cause non-compliance with local regulations.
    • •Submitting a CIP without a thorough risk management plan, as per ISO 14971, can lead to study approval issues.

    Frequently asked questions

    The primary purpose of a CIP is to define the objectives, design, methodology, statistical considerations, organization, and conduct of a clinical investigation. It ensures the scientific soundness of the study and protects the rights, safety, and well-being of the subjects.

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    Sources

    3 sources

    Sources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

    Tier 1Binding law and standards· 1Tier 2Regulator guidance and consensus· 1Tier 3Peer-reviewed and registry evidence· 1
    Link health: 3 verified· last checked 2026-06-20
    ISO·1FDA·1NIH·1
    1. 1
      ISO 14155
      Tier 1 Verified
      ISOiso.org
    2. 2
      FDA - Clinical Trials and Human Subject Protection
      Tier 2 Verified
      FDAfda.gov
    3. 3
      ClinicalTrials.gov
      Tier 3 Verified
      NIHclinicaltrials.gov

    Inline markers like [1] jump to the matching reference above.