Guidance

Medical devices: legal requirements for specific medical products

Guidance for manufacturers on the regulations that apply to prosthetic, orthotic and ophthalmic devices.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 1 September 2014
• Last updated: 1 July 2023 — See all updates

Documents

Medical devices: legal requirements for specific medical products

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Read this for information on how to comply with the legal requirements for prosthetic, orthotic and opthalmic devices.

Published 1 September 2014
Last updated 1 July 2023 + show all updates

1. 1 July 2023

   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.

2. 17 May 2023

   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.

3. 1 March 2021

   Updated references to CE, CE UKNI and UKCA markings in line with the end of the Brexit transition period.

4. 1 September 2014

   First published.