Since the UK’s exit from the EU in January 2021, several changes have been implemented, which are required by manufacturers to market their medical device(s), including IVDs, custom-made devices and system or procedure packs on the UK market. One of those changes has been the requirement for non-UK manufacturers to appoint a UK Responsible Person (UKRP) if you do not have a registered address in the UK. Although Northern Ireland is classed as being part of the UK, they have adapted to follow the requirements under the EU Medical Device Regulation and In Vitro Diagnostic Regulation.
Under the UK MDR 2002 (as amended in 2019), the definition of a UKRP is as follows:
“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 regard to the manufacturer’s obligations under these regulations.”
The UKRP is the UK equivalent of the EU Authorised Representative for EU MDR and IVDR; this is no longer applicable within the UK.
The UKRP is responsible for the following activities:
- Managing your device registrations with the Medicines & Healthcare Regulatory Agency (MHRA).
- Ensuring that your declaration of conformity and technical documentation has been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.
- Keep available a copy of your 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.
- Responding to requests from the MHRA and providing them with all the information and documentation necessary to demonstrate the conformity of a device.
- Provide samples of your device to the MHRA or allow them access to the device where the UK Responsible Person has samples. Where they do not have access or samples, forward to the manufacturer any request from the MHRA for samples or access.
- Co-operate with the MHRA on any preventive or corrective action taken to eliminate risks or mitigate risks posed by the device.
- Immediately inform you about complaints and reports from healthcare professionals, patients and users about suspected incidents related to your device for which they have been designated.
- Terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these regulations and inform the MHRA and, if applicable, the relevant Approved body of that termination.
Any device currently on the UK market should now be registered with the MHRA. The name and address of the UKRP, where applicable, will need to be included on the device labelling where the UKCA mark has been affixed.
Although the MHRA announced in October 2022 that there will be a 12-month extension to the implementation of the future UK Medical Device Regulations (July 2024), there is still a requirement now to have a UKRP for selling devices on the UK market.
To appoint your UKRP, you will need a “letter of designation” that states the company name and address for both the non-UK manufacturer and the UKRP.
The letter will need to state that the UKRP is acting with consent from the non-UK manufacturer and will adhere to the regulation that applies to the device(s) that are being placed on the Great Britain market. The letter will need to be agreed upon and signed by both parties.
LFH Regulatory has a registered UK office and can act as your UK Responsible Person. Contact us today to see how we can help.
Written by Laura Friedl-Hirst, Managing Director and Principal Consultant at LFH Regulatory Ltd.
