As a leading regulatory and compliance partner for International Businesses, trust 8foldGovernance to act as your UKRP.
Medical Device developers and manufacturers based outside the UK, selling or distributing medical devices in the UK, must designate a UK-based Responsible Person or ‘UKRP’.
Key Responsibilities of a UK Responsible Person (UKRP)
A UK Responsible Person acts as the intermediary between the Medical Device manufacturer and the UK Medicines and Healthcare products Regulatory Agency (MHRA), and is responsible for:
We are registered with the MHRA to provide UKRP services, ensuring full compliance with UK Medical Device Regulations.
Our expert team can handle the entire process of Regulatory approval from conception to product registration. Explore our complete Regulatory services offering below:
A UK Responsible Person (UKRP) is a designated entity or individual based in the UK who acts as the intermediary for non-UK medical device developers and manufacturers selling or distributing in the UK, and the UK Medicines and Healthcare products Regulatory Agency (MHRA). Post-Brexit regulations (effective from January 2022), stipulate that you need a UKRP if you are a medical device developer or manufacturer based outside the UK and intend to sell or distribute your devices in the UK. This designation ensures compliance with UK Medical Device Regulations.
The key responsibilities of a UKRP include, but are not limited, to ensuring regulatory compliance of medical devices, keeping technical documentation accessible to the MHRA for inspection, facilitating communication between the MHRA and the manufacturer, and reporting complaints or feedback from healthcare professionals, patients, and users to the manufacturer.
As a UKRP, we are registered with the MHRA to provide UKRP services. This ensures that your medical device remains compliant with UK regulations. Our expertise also extends to the digital health and technology medical device sector, where we have a proven track record of implementing high standards in compliance. Additionally, we also offer support for engaging with the NHS, making us a valuable partner for establishing your market presence in the U.K.
To learn more about our UKRP services and find out how we can support your business with compliance in the UK market, simply book a no-obligation discovery call with one of our regulatory experts.
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