Change of https://www.gov.uk/government/publications/medical-devices-legal-requirements-for-specific-medical-devices

Change description : 2023-05-17 13:14:00: 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. [Guidance and regulation]

Showing diff : ..2023-05-17 12:18:05.101427818 +00:00

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: 17 May 2023 — See all updates

Documents

Medical devices: legal requirements for specific medical products

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Details

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

Published 1 September 2014
Last updated 17 May 2023 + show all updates

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.
1 March 2021
Updated references to CE, CE UKNI and UKCA markings in line with the end of the Brexit transition period.
1 September 2014
First published.

Update history

2026-07-20 09:06
Updated to clarify registration requirements

2025-12-17 13:02
Removed ‘Activities not covered by the UK MDR 2002’ paragraph from ‘Prosthetic and orthotic devices’ section.

2023-07-01 00:01
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.

2023-05-17 13:14
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.