Virtual manufacturing of medical devices
Guidance for manufacturers who don’t design or manufacture devices but place their names on the product.
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All virtual manufacturers must now hold the full technical documentation for any product they place on the market under their name.
Last updated 3 February 2021 + show all updates
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Published a new version of the guidance following the end of the transition period. We have also converted the guidance into HTML.
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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
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First published.
