Virtual manufacturing of medical devices

Guidance for manufacturers who don’t design or manufacture devices but place their names on the product.



All virtual manufacturers must now hold the full technical documentation for any product they place on the market under their name.

Published 29 March 2017
Last updated 1 July 2023 + show all updates
  1. 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. 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. Published a new version of the guidance following the end of the transition period. We have also converted the guidance into HTML.

  4. New sections added on: What options does a virtual manufacturer have if their OEM loses their CE certificate? If a virtual manufacturer wants to change from being the legal manufacturer to the distributor

  5. First published.