Module 17 2024

05/12/2024

Chapter 3: Economic Operators

Quality Management Systems The regulations will require all medical device manufacturers, including manufacturers of Class I devices and custom-made devices, to apply an appropriate QMS. The MHRA will provide further guidance on QMS requirements. At present, there is no specific requirement for ISO13485 to be used, but it is likely that this will be the outcome of the MHRA guidance. UK Responsible Persons (UKRP) The regulations will include a requirement that the UK Responsible Person must have a physical address in the UK. The use of “forwarding addresses” for individuals located outside the UK will not be acceptable.

The Organisation for Professionals in Regulatory Affairs

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Chapter 3: Economic Operators

UK Responsible Persons (UKRP) The UKRP will be legally liable (responsible or answerable in law) for defective medical devices on the same basis as the manufacturer The regulations will require manufacturers and UKRPs to draw up a legal contract, the regulations will also require manufacturers to draw up a changeover agreement when changing their UKRP The regulations will require UKRPs to retain or have access to technical documentation for the expected lifetime of devices after the product has last been manufactured or 15 years (whichever is longer) for implantable devices and 10 years for non-implantable devices. UKRP’s to have a Qualified Person permanently and continuously at their disposal.

The Organisation for Professionals in Regulatory Affairs

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