Guidance

Virtual manufacturing of medical devices

Guidance for manufacturers who source their own-branded products from another company.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 29 March 2017
• Last updated: 1 July 2023
  Show all updates

  1. 1 July 2023

     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. 17 May 2023

     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. 3 February 2021

     Published a new version of the guidance following the end of the transition period. We have also converted the guidance into HTML.

  4. 9 April 2019

     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. 29 March 2017

     First published.

Documents

Virtual manufacturing of medical devices

HTML

Details

This guidance provides information about:

• the responsibilities of a virtual manufacturer
• the technical documentation that must be complete
• minimal contractual agreements
• disputes and issues
• changes in arrangements