Approved bodies for medical devices
Information about how approved bodies help regulate medical devices and how to apply for approval.
Documents
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.
Updates to this page
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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.
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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.
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First published.