Guidance

Virtual manufacturing of medical devices

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

Documents

Details

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 3 February 2021 + show all updates
  1. Published a new version of the guidance following the end of the transition period. We have also converted the guidance into HTML.

  2. 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

  3. First published.