Guidance

Notified bodies for medical devices

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

Documents

Requirements for UK notified bodies

This file may not be suitable for users of assistive technology. Request an accessible format.

If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gsi.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Details

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

  • the legislation which governs medical devices
  • the role of the notified body
  • lists of approved notified bodies
  • how to become a notified body
Published 18 December 2014
Last updated 22 June 2017 + show all updates
  1. Link to 'EU Notified Bodies' changed.
  2. First published.