In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice
Covers good study practice for clinical performance studies of in vitro diagnostic devices that use specimens from human subjects.
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 |
|---|---|---|---|---|
| European Union | Harmonized | EN ISO 20916:2024 (ISO 20916:2019) | - | Recognition number IVDR entry 15. Effective October 9, 2024. Devices that conform to the standard are presumed to conform with the requirements of the Regulation that the standard covers. |
| United Kingdom | Not recognized | - | - | A device that conforms to this standard does not get the statutory presumption of conformity, because the standard is not designated.. The complete list of designated standards published in January 2026 does not name this standard. |
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: CLSI EP06, CLSI EP07, CLSI EP09c, CLSI EP12, CLSI EP19, CLSI EP21, CLSI EP25, CLSI EP35, ISO 17511, NPAAC in-house IVD standard, CLSI EP05, CLSI EP14. See .
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.
| Canada | Not recognized | - | - | The standard does not appear on the list of recognized standards. A manufacturer may still give other evidence of safety or effectiveness. |
| Australia | Referenced | ISO 20916:2019 | - | Voluntary. The TGA lists it as relevant to clinical evidence. A strong justification is expected if a recognised standard is not followed. |