Clinical investigation of medical devices for human subjects - Good clinical practice
The text of this standard is sold by ISO and is not reproduced here. This page gives the code, edition, scope and what each market says about it.
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
| Market | Status | Edition accepted | National code | Details |
|---|---|---|---|---|
| United States | Recognized | Third edition 2020-07 | - | Recognition number 2-282. Voluntary: a declaration of conformity to a recognized standard can be used in a submission. |
| European Union | Harmonized | EN ISO 14155:2020 with amendment A11:2024 (ISO 14155:2020) | - | Recognition number MDR entry 39. Effective January 30, 2026. Devices that conform to the standard are presumed to conform with the requirements of the Regulation that the standard covers. |
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: E6(R3), E8(R1), E9(R1), NHMRC National Statement, Declaration of Helsinki. See all standards.
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.
| United Kingdom | Recognized | EN ISO 14155:2011 with corrigendum AC:2011 | - | Recognition number List row 144. Voluntary: a device that conforms to a designated standard is treated as complying with the related essential requirement unless there are reasonable grounds to suspect that it does not.. MHRA clinical investigation guidance of October 2025 says ISO 14155:2020 is not a designated standard but expects manufacturers to follow it as best practice. |
| Japan | Referenced | ISO 14155:2020 | - | Partial recognition. The guidance uses Annex A for the protocol, Annex B for the investigator brochure and Annex D for the report. The Japanese GCP ordinance is the legal standard for the conduct of clinical trials.. ISO 14155:2020 counts as a foreign standard equal to or higher than the Japanese device GCP, and its annexes are named as references for protocol, brochure and report content. |
| Canada | Recognized | Latest version (the list gives no edition or year) | - | When a new version is published, both the newest and the previous version stay recognized for 3 years from the date the newest version was published.. Voluntary: a manufacturer meets the standard, meets an equivalent or better standard, or gives other evidence of safety or effectiveness. A Declaration of Conformity is submitted when a recognized standard is used. |
| Australia | Referenced | ISO 14155:2020 | - | The TGA expects clinical trials to comply with ISO 14155:2020 and the ICH good clinical practice guideline. Studies that do not follow the applicable ethical standards are not relied on. |