Guidance

Approved bodies for medical devices

Guidance on what approved bodies are, what they do and how you can become one.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 31 December 2020
• Last updated: 1 July 2023 — See all updates

Documents

Approved bodies for medical devices

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Details

This Medicines and Healthcare products Regulatory Agency (MHRA) guidance covers:

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

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.