--- title: "CIP, Clinical Investigation Plan | MedTech Terms" description: "EU MDR's term for the protocol document governing a clinical investigation of a device. Plain-English Clinical & Trials definition for MedTech teams, with examp" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/cip#term", "name": "Clinical Investigation Plan", "alternateName": "CIP", "description": "ISO 14155 and MDR Annex XV define the required content of the CIP - objectives, design, statistical considerations, ethical considerations, monitoring, and reporting. 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Any significant changes to the CIP that affect the scientific integrity of the study, the rights or safety of subjects, or the conduct of the investigation must be formally amended, submitted to regulatory authorities and ERBs, and re-approved before implementation." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Clinical & Trials](/terms?cat=Clinical%20%26%20Trials) 6. / 7. Clinical Investigation Plan [All terms](/terms) Clinical & Trials [Regulated Pathways](/ecosystems/regulated-pathways)[Clinical Evidence](/ecosystems/clinical-evidence)[Global Markets](/ecosystems/global-markets)CIP # 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 Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition [ISO 14155](/terms/iso-14155) and [MDR](/terms/mdr-reporting) 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](/terms/iso-14155):2020 which specifies requirements for the conduct of clinical investigations of medical devices. The EU [MDR](/terms/mdr-reporting), 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](/terms/ide) (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](/terms/mdr-reporting), 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 What is the primary purpose of a Clinical Investigation Plan? 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. How does the CIP relate to ethical review boards? Can a CIP be amended after approval? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory EU Medical Device Regulation(MDR) Regulation (EU) 2017/745 governing medical devices in the European Union. ](/terms/mdr)[ Standards ISO 14155 Good clinical practice for clinical investigations of medical devices. ](/terms/iso-14155) ### More in Clinical & Trials · Same category [ Clinical & Trials Adaptive Trial Design Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data. ](/terms/adaptive-trial)[ Clinical & Trials Adverse Event(AE) Any untoward medical occurrence in a subject, whether or not related to the device. ](/terms/adverse-event)[ Clinical & Trials ALCOA+ Data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate (plus Complete, Consistent, Enduring, Available). ](/terms/alcoa-plus)[ Clinical & Trials Analytical Sensitivity An IVD's ability to detect small quantities of an analyte. ](/terms/analytical-sensitivity) Cited by Where this term appears across MedTech Terms. Ecosystems (3) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Clinical Evidence](/ecosystems/clinical-evidence) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ISO· 1 FDA· 1 NIH· 1 1. [1 ISO 14155 Verified ISO · iso.org ](https://www.iso.org/standard/71690.html) 2. [2 FDA - Clinical Trials and Human Subject Protection Verified FDA · fda.gov ](https://www.fda.gov/science-research/science-and-research-special-topics/clinical-trials-and-human-subject-protection) 3. [3 ClinicalTrials.gov Verified NIH · clinicaltrials.gov ](https://clinicaltrials.gov/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Clinical evidence intersecting with device security? We support clinical-stage MedTech teams whose investigational devices touch patient data or hospital networks. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Clinical & Trials Acronym CIP Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=cip) Learn in 60 seconds Card Lesson Quiz EU MDR's term for the protocol document governing a clinical investigation of a device. - · Sponsors running global trials typically maintain a single harmonized CIP/Protocol with regional appendices for FDA, MDR, and other regulators. - · Functionally analogous to a U.S. - · clinical investigation protocol. Remember this Watch out: Failing to align the CIP with the Investigational Device Brochure (IDB) can lead to regulatory delays and ethical concerns. Related terms - [ISO 14155 ](/terms/iso-14155) - [EU Medical Device Regulation(MDR) ](/terms/mdr) You may also need Auto-suggested from Clinical & Trials and shared keywords. - [Clinical Evaluation Plan(CEP) ](/terms/clinical-evaluation-plan) - [IDE Annual Progress Report ](/terms/ide-annual-report) - [Protocol Deviation ](/terms/protocol-deviation) - [Good Clinical Practice(GCP) ](/terms/gcp) - [ICH E6 Good Clinical Practice(GCP) ](/terms/ich-gcp) - [Investigator Brochure(IB) ](/terms/investigator-brochure) [All Clinical & Trials terms](/terms?cat=Clinical%20%26%20Trials) From the Blue Goat network Related resources and services on this topic. - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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