A new role – the UK Responsible Person – has been introduced under the UK MDR, which applies from 1st January, 2021.
According to UK Medical Device Regulation;
“UK Responsible Person (UKRP) means a person established in the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regards to the manufacturer’s obligations under UK regulations.”
From 1st January, 2021, designating UK Responsible Person (UKRP) is a legal requirement for non-UK based manufacturers of medical devices for successful entry in the Great Britain (England, Wales and Scotland) market. Therefore, any non-UK based manufacturer who wishes to make their devices available within the Great Britain market requires a UKRP which meets the requirements laid out in the applicable legislation.
HDJ Ltd as your UKRP will have the following responsibilities:
- Ensure 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.
- Keep 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, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device.
- Where they have samples of the devices or access to the device, comply with any request from the MHRA to provide such samples or access.
- Where they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the MHRA to provide such samples or access, and communicate to the MHRA whether the manufacturer intends to comply with that request.
- Cooperate 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 inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed.
- If the manufacturer acts contrary to its obligations under the applicable Regulations:
- Terminate the legal relationship with the manufacturer and
- Inform the MHRA and, if applicable, the relevant Approved Body of that termination.