Regulatory guidance for medical devices

Check the legal requirements you need to meet before you can place a medical device on the market and see how MHRA monitors compliance.

Published 18 December 2014
Last updated 31 March 2020 + show all updates
  1. Added a new section on COVID-19 medical devices guidance

  2. Added a link to guidance for manufacturers who don’t design or manufacture devices but place their names on the product.

  3. Added a link to Medical devices: how to comply with the legal requirements guidance.

  4. Added new document on devices which incorporate an ancillary medicinal substance

  5. First published.