Medical devices - Application of risk management to medical devices
A process standard for managing risk over the life of a device. It does not list detailed acceptance criteria for performance tests.
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 2019-12 | - | Recognition number 5-125. Voluntary: a declaration of conformity to a recognized standard can be used in a submission. |
| European Union | Harmonized | EN ISO 14971:2019 with amendment A11:2021 (ISO 14971:2019) | - | Recognition number MDR entry 16; IVDR entry 10. Effective May 12, 2022. 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: GB/T 42062-2022, YY/T 0316-2016, Q9(R1), JIS T 14971, ISO 22442-1, ISO 22442-2, ISO 22442-3. 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 14971:2019 with amendment A11:2021 | - | Recognition number List row 159. 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. |
| Japan | Adopted | ISO 14971:2019, identical JIS version | JIS T 14971:2020医療機器―リスクマネジメントの医療機器への適用 | Application documents describe risk management carried out with reference to JIS T 14971 or ISO 14971. |
| China | Adopted | ISO 14971:2019, identical adoption | GB/T 42062-2022Medical devices - Application of risk management to medical devices | Effective November 1, 2023. Recommended national standard, listed as current. |
| 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 | - | - | Voluntary. The TGA treats it as a way to show compliance with the Essential Principles but does not require it. |