Guidance

Approved bodies for medical devices

Information about how approved bodies help regulate medical devices and how to apply for approval.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 31 December 2020
• 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. 31 December 2020

     First published.

Documents

Approved bodies for medical devices

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Details

This guidance explains:

• the legislation which governs medical devices
• the role of the approved body
• how to become an approved body

You can read our guidance about the current UK approved bodies.