About This Service
Your UK Regulatory Partner
Since Brexit, manufacturers based outside Great Britain must appoint a UK Responsible Person (UKRP) to place medical devices on the Great Britain market. The UKRP acts as the manufacturer's representative in the UK, helping ensure devices meet the requirements of UK MDR 2002 and serving as a key point of contact with the MHRA.
Key Health provides UK Responsible Person (UKRP) services for manufacturers of Class I, IIa, IIb and III medical devices based outside Great Britain. We currently act for a growing portfolio of international manufacturers across Europe, North America and Asia, supporting organisations entering the Great Britain market, launching additional products or transferring from an existing UK Responsible Person.
Unlike providers that offer only an administrative UK address, we bring practical expertise in medical devices, quality management systems and regulatory compliance. As an ISO 13485-certified organisation with practical experience of UK MDR requirements, we understand the challenges manufacturers face and provide informed, responsive support throughout the regulatory process.
Our service covers initial onboarding and technical documentation review through to MHRA registration management, regulatory liaison, technical documentation retention, post-market surveillance, vigilance and incident reporting support, and ongoing compliance guidance – helping manufacturers maintain regulatory confidence and protect their access to the Great Britain market.