Clinical Investigation of Medical Devices for Human Subjects — Good Clinical Practice
ISO 14155:2026 is the good clinical practice standard for clinical investigations of medical devices in human subjects, governing their design, conduct, recording and reporting. It protects the rights, safety and well-being of subjects and ensures the scientific validity of the data. Edition 4, published in March 2026, is the current version and supersedes ISO 14155:2020, which strengthened risk-based principles, ethics-committee and informed-consent detail, and alignment with ISO 14971. The standard is referenced by the EU Medical Device Regulation for clinical investigations and recognised by FDA for device clinical data. It is the device-world analogue of ICH E6, the GCP standard for medicinal-product trials.
What this does not cover
stated in the document's own scope- It covers device clinical investigations, not medicinal-product trials, which follow ICH E6.
- It is not the EU regulatory authorisation route itself; procedural obligations are set by EU MDR (EU) 2017/745.
- It does not define device risk management; that process is specified by ISO 14971.
- It does not cover in vitro diagnostic performance studies, which have their own framework (ISO 20916 / IVDR).
Always verify against the current published text before relying on it for a submission or inspection.
Overview
ISO 14155 sets the good clinical practice requirements for clinical investigations of medical devices in human subjects. It exists to protect participants and to make device clinical data credible and reconstructable, covering design, conduct, recording and reporting from planning through the final report. Edition 4 (2026) is the current version, superseding the 2020 edition that had tightened risk-based principles, ethics and informed-consent provisions and alignment with ISO 14971. The standard defines sponsor and investigator responsibilities, the clinical investigation plan, safety reporting, and record-keeping, giving device studies a structured GCP framework parallel to the one ICH E6 provides for medicinal-product trials.
Legal basis & how it acquires force
ISO 14155 is a voluntary consensus standard whose force comes from regulatory reference. The EU Medical Device Regulation (EU) 2017/745 points to it for the conduct of clinical investigations, so it effectively underpins CE-mark clinical evidence, and it is a harmonised standard in that framework. FDA recognises it as a consensus standard for accepting device clinical data, including data from investigations conducted outside the US. Within a manufacturer's system it connects to ISO 13485 and ISO 14971.
Document structure
| Part | Covers |
|---|---|
| Scope, terms and ethical principles | Subject protection and scientific data validity. |
| Risk management for the investigation | Link to ISO 14971 and risk-based conduct. |
| Clinical investigation plan (CIP) | Design, objectives and endpoints. |
| Responsibilities | Sponsor, principal investigator, monitors and the ethics committee. |
| Conduct and data handling | Informed consent, source data, monitoring and safety reporting. |
| Clinical investigation report and record retention | Reporting of results and retention of records. |
Key requirements
- Base the clinical investigation on a documented risk assessment aligned with ISO 14971.
- Obtain and document freely given informed consent before any investigation-specific procedure.
- Secure a favourable opinion from an ethics committee and required regulatory authorisation before starting.
- Define roles and responsibilities for the sponsor, the principal investigator and monitors, including monitoring and data-integrity arrangements.
- Follow a clinical investigation plan (CIP) and record data so that reported results are verifiable against source.
- Report adverse events and device deficiencies within defined timelines and evaluate them for safety impact.
- Retain investigation records and produce a clinical investigation report on completion.
Implementation tips
- Build the clinical investigation plan on the ISO 14971 risk file so investigation risks map to identified device hazards.
- Align consent, ethics and reporting workflows with EU MDR clinical-investigation articles where the study supports a CE mark.
- Define source-data and monitoring expectations up front so recorded data stays reconstructable across sites.
International alignment
ISO 14155 is developed by ISO/TC 194 and aligns with ISO 14971 risk management and the ethical principles of the Declaration of Helsinki. The EU MDR references it for clinical investigations, giving it harmonised-standard status, and FDA recognises it for device clinical data. It is deliberately structured to parallel ICH E6 GCP, so sponsors running both drug and device studies see a consistent framework.
ISO 14155:2026: frequently asked questions
Quick answers to common questions about ISO 14155:2026.
Which edition of ISO 14155 is current?
ISO 14155:2026 (Edition 4, published March 2026) is current and supersedes ISO 14155:2020.
How does ISO 14155 relate to EU MDR?
The EU Medical Device Regulation references ISO 14155 for the conduct of clinical investigations, so it underpins clinical evidence for CE marking.
Is ISO 14155 the same as ICH E6?
No, but it is the device analogue. ICH E6 is GCP for medicinal-product trials; ISO 14155 is GCP for medical-device clinical investigations.
Does FDA accept data from ISO 14155 investigations?
FDA recognises ISO 14155 as a consensus standard and accepts conforming device clinical data, including studies conducted outside the US, subject to its own requirements.