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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 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.
    Grouped by theme

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    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

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