Information supplied by the manufacturer of medical devices
A European standard on the information that the manufacturer supplies with a medical device, such as labels and instructions for use.
The text of this standard is sold by CEN 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 Kingdom | Recognized | EN 1041:2008 | - | Recognition number List row 9. 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. |
Related standards: ISO 15223-1, ISO 18113-1, 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.