Module 17 2024

Howard Dobbs

04/12/2024

MHRA Guidance, January 2021 Section 9: If a VM wants to change from being the legal Manufacturer to the Importer/Distributor

• Only the following are allowed: -

relabel (translate the label into English) - repack the device - state clearly on the label and package who is the manufacturer and who is the importer/distributor - no change to the intended use

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

41

MHRA Guidance, January 2021 Summary and comments

• VMs are treated in the same way as other manufacturers • If the VM sells products which are not class I , it must have a QMS which must be audited by a UKAB and for each product it must hold full technical documentation which must be “fully integrated” into its QMS • If the VM sells only products which are class I , it must hold the full technical documentation in case of MHRA scrutiny and it must register its devices with the MHRA • In both cases the VM must fulfil the usual PMS and vigilance reporting obligations • Few uncertainties remain

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

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