Module 17 2024

Howard Dobbs

04/12/2024

MHRA Guidance, January 2021 Section 3: What is a virtual manufacturer?

• A VM is an organization that fully sources its own named product from another company (sometimes known as “the original equipment manufacturer”), which has designed and manufactured an identical UKCA/CE/CE UKNI marked product. By placing their own name and address on the product, the VM takes on the legal responsibilities for the medical device and is therefore regarded as the manufacturer in accordance with the UK MDR 2002 (SI 2002 No 618, as amended). • In practice there is no difference in the regulatory requirements applying to a manufacturer and a VM .

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

37

MHRA Guidance, January 2021 Section 4: Responsibilities

• Where UK Approved Body or EU NB certification is required - have a QMS which will be audited by your UK Approved Body or EU NB - hold the full technical documentation for the device, which may be reviewed by your UK Approved Body or EU NB • Where UK Approved Body or EU NB certification is not required - hold the full technical documentation, which may be examined by the MHRA – register your devices with the MHRA

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

38

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