--- title: "ISO 14155, Definition | MedTech Terms" description: "Good clinical practice for clinical investigations of medical devices. 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This includes selecting qualified investigators and ensuring appropriate oversight." } }, { "@type": "Question", "name": "Does ISO 14155 apply to post-market clinical follow-up (PMCF) studies?", "acceptedAnswer": { "@type": "Answer", "text": "Yes, the principles of ISO 14155 are generally applicable to PMCF studies, especially when these studies involve collecting new clinical data from human subjects to address specific questions about a device's safety or performance in its post-market phase." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Standards](/terms?cat=Standards) 6. / 7. ISO 14155 [All terms](/terms) Standards [Quality System](/ecosystems/quality-system)[Clinical Evidence](/ecosystems/clinical-evidence) # ISO 14155 Good clinical practice for clinical investigations of medical devices. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition ISO 14155:2020 addresses [good clinical practice](/terms/gcp) for the design, conduct, recording, and reporting of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes. What the regulation says ISO 14155:2020 outlines the principles of [good clinical practice](/terms/gcp) (GCP) for medical device clinical investigations, ensuring the protection of human subjects, the scientific integrity of the investigation, and the reliability of study results. The EU [MDR](/terms/mdr-reporting), specifically in Annex XV, refers to the principles of ISO 14155 for clinical investigations of devices. ## What this means in practice ISO 14155 is the device-specific counterpart to ICH- [GCP](/terms/gcp) and is referenced by EU [MDR](/terms/mdr-reporting) clinical investigation requirements. ## Examples - A MedTech company conducting a clinical investigation for a novel coronary stent needs to ensure all study procedures, from subject consent to data collection, are compliant with ISO 14155:2020. - Before initiating a multi-center clinical trial for a new diagnostic imaging device, the sponsor performs site audits to verify that each participating institution understands and can adhere to ISO 14155 requirements. - During a clinical investigation for a new orthopedic implant, a data monitoring committee operating under ISO 14155 principles reviews accumulating data to ensure subject safety and ethical conduct. Common pitfalls - • Failing to update clinical investigation procedures to align with the 2020 revision of ISO 14155 can lead to non-compliance. - • Applying pharmaceutical good clinical practice (GCP) guidelines directly to MedTech without considering the specific nuances of ISO 14155 can result in inefficient or inappropriate study designs. - • Neglecting the ethical considerations and subject protection requirements detailed in ISO 14155 can lead to regulatory enforcement actions and reputational damage. - • Not adequately training investigators and site staff on ISO 14155 principles can compromise data quality and subject safety. - • Incorrectly managing clinical investigation data according to ISO 14155 can invalidate study results for regulatory submissions. ## Frequently asked questions How does ISO 14155 differ from ICH-GCP? ISO 14155 is specifically tailored for medical devices, addressing their unique characteristics like device-specific risks and iterative design, while ICH- [GCP](/terms/gcp) is focused on pharmaceuticals. Both share core principles of ethical conduct and data integrity. Is ISO 14155 mandatory for all clinical investigations? What is the role of a sponsor in an ISO 14155 compliant study? Does ISO 14155 apply to post-market clinical follow-up (PMCF) studies? ## Cross-references ### Uses Concepts or artefacts this term builds on. - [ ICH E6 Good Clinical Practice(GCP) ](/terms/ich-gcp) ### Contains Sub-elements or required artefacts of this term. - [ Adverse Event(AE) ](/terms/adverse-event) - [ Protocol Deviation ](/terms/protocol-deviation) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Clinical & Trials Investigational Device Exemption(IDE) FDA authorization to use an investigational device in a clinical study. ](/terms/ide)[ Clinical & Trials ICH E6 Good Clinical Practice(GCP) International standard for the design, conduct, and reporting of clinical trials. ](/terms/ich-gcp) ### Clinical Trials & Evidence · From this learning path [ Commercialization Good Clinical Practice(GCP) International quality standard for designing and conducting clinical trials. Adjacent lesson ](/terms/gcp?from=clinical-trials-and-evidence)[ Clinical & Trials Investigator Brochure(IB) Compilation of clinical and nonclinical information on an investigational device given to clinical investigators, establishes what's 'anticipated' for UADE determinations. Adjacent lesson ](/terms/investigator-brochure?from=clinical-trials-and-evidence)[ 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?from=clinical-trials-and-evidence)[ Clinical & Trials Adverse Event(AE) Any untoward medical occurrence in a subject, whether or not related to the device. ](/terms/adverse-event?from=clinical-trials-and-evidence) ### Standards Stack for Medical Devices · From this learning path [ Standards ISO 11135 Standard for development, validation, and routine control of ethylene oxide (EO) sterilization. Adjacent lesson ](/terms/iso-11135?from=standards-stack)[ Standards IEC 60601-1 General requirements for basic safety and essential performance of medical electrical equipment. ](/terms/iec-60601-1?from=standards-stack)[ Standards IEC 60601-1-2 EMC requirements for medical electrical equipment. ](/terms/iec-60601-1-2?from=standards-stack)[ Standards IEC 62304 Lifecycle requirements for medical device software. ](/terms/iec-62304?from=standards-stack) Cited by Where this term appears across MedTech Terms. Learning paths (2) - [Clinical Trials & Evidence](/paths/clinical-trials-and-evidence)Lesson 7 of 18 - [Standards Stack for Medical Devices](/paths/standards-stack)Lesson 9 of 10 Ecosystems (2) - [Quality System](/ecosystems/quality-system) - [Clinical Evidence](/ecosystems/clinical-evidence) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ISO· 1 AAMI· 1 FDA· 1 1. [1 ISO 14155:2020 Verified ISO · iso.org ](https://www.iso.org/standard/71690.html) 2. [2 AAMI Standards Verified AAMI · aami.org ](https://www.aami.org/standards) 3. [3 FDA Recognized Consensus Standards Verified FDA · accessdata.fda.gov ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Implementing this standard on a device program? Blue Goat Cyber helps MedTech teams operationalize cybersecurity standards across the design and post-market lifecycle. [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 Standards Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=iso-14155) Learn in 60 seconds Card Lesson Quiz Good clinical practice for clinical investigations of medical devices. - · ISO 14155 is the device-specific counterpart to ICH-GCP and is referenced by EU MDR clinical investigation requirements. Remember this Watch out: Failing to update clinical investigation procedures to align with the 2020 revision of ISO 14155 can lead to non-compliance. Related terms - [ICH E6 Good Clinical Practice(GCP) ](/terms/ich-gcp) - [Investigational Device Exemption(IDE) ](/terms/ide) You may also need Auto-suggested from Standards and shared keywords. - [ISO 20916 ](/terms/iso-20916) - [Clinical Evaluation Plan(CEP) ](/terms/clinical-evaluation-plan) - [Contract Research Organization(CRO) ](/terms/cro) - [Good Clinical Practice(GCP) ](/terms/gcp) - [Investigator-Initiated Trial(IIT) ](/terms/investigator-initiated-trial) - [Essential Performance ](/terms/essential-performance) [All Standards terms](/terms?cat=Standards) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.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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