A UK Responsible Person is appointed by an outside-UK manufacturer to carry out specified tasks related to the manufacturer’s obligations.
The UK responsible person's obligations include:
- Registering the manufacturer’s devices with the MHRA before the devices are placed on the Great Britain market.
- Ensuring that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.
- Keeping available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA.
- In response to a request from the MHRA, providing the MHRA with all the information and documentation necessary to demonstrate the conformity of a device.
- Providing samples of a device to the MHRA or allow the MHRA access to the device where the UK Responsible Person has samples or access or, where they do not have access or samples, forwarding to the manufacturer any request from the MHRA for samples or access.
- Cooperating with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.
- Immediately informing the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.
- Terminating the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under the applicable Regulations and informing the MHRA and, if applicable, the relevant Notified Body of that termination.
A full description of the obligations of UK responsible persons can be found on the MHRA website.