Guidance
Medical devices: legal requirements for specific medical products
Information for manufacturers on the regulations that apply to prosthetic, orthotic and ophthalmic devices.
Applies to England, Scotland and Wales
Documents
Details
How to comply with the legal requirements for prosthetic, orthotic and ophthalmic devices, including:
- classification
- custom-made prosthetic, orthotic and ophthalmic devices
- examples
Updates to this page
Published 1 September 2014
Last updated 1 July 2023
show all updates
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This guidance has been updated now that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023.
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Paragraph added to this page which explains that the government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023.
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Updated references to CE, CE UKNI and UKCA markings in line with the end of the Brexit transition period.
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First published.