Guidance

Medical devices: legal requirements for specific medical products

Information 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: 20 July 2026
  Show all updates

  1. 20 July 2026

     Updated to clarify registration requirements

  2. 17 December 2025

     Removed 'Activities not covered by the UK MDR 2002' paragraph from 'Prosthetic and orthotic devices' section.

  3. 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.

  4. 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.

  5. 1 March 2021

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

  6. 1 September 2014

     First published.

Applies to England, Scotland and Wales

• Publication for Northern Ireland

Documents

Legal requirements for specific medical devices

HTML

Details

How to comply with the legal requirements for prosthetic, orthotic and ophthalmic devices, including:

• classification
• custom-made prosthetic, orthotic and ophthalmic devices
• examples