Collection

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 29 March 2017 + show all updates
  1. Added a link to guidance for manufacturers who don’t design or manufacture devices but place their names on the product.
  2. Added a link to Medical devices: how to comply with the legal requirements guidance.
  3. Added new document on devices which incorporate an ancillary medicinal substance
  4. First published.