In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements
Gives terms, definitions and general requirements for the information a manufacturer supplies with in vitro diagnostic devices.
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 18113-1:2024 (ISO 18113-1:2022) | - | Recognition number IVDR entry 19. Effective January 30, 2026. Devices that conform to the standard are presumed to conform with the requirements of the Regulation that the standard covers. |
Related standards: ISO 15223-1, EN 1041, ISO 18113-2, ISO 18113-3, ISO 18113-4, ISO 18113-5. 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.