UK Responsible Person

Meet Regulatory Requirements Seamlessly with a UK Responsible Person (UKRP)

Introduction

If you're a medical device and IVD manufacturer without a registered office in the UK, you must appoint a local representative, your UKRP. Your UKRP plays a critical role in ensuring compliance with UK requirements for medical devices and In Vitro Diagnostic Medical Devices distributed in the UK market. Additionally, your UKRP is responsible for managing your device registration as well as any relevant importer relationships and liaising with the Medicines and Healthcare Products Regulatory Agency (MHRA) on your behalf.

UKCA Certification and EU MDR/IVDR Alignment

Due to Brexit, MHRA has indicated that medical devices and IVD regulations will align closely with the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). The UK Responsible person is the UK equivalent of the EU Representative.

Conformitè Europëenne (CE) marked devices will initially be recognized in the UK, but manufacturers will have to obtain UK Conformity Assessment (UKCA) certification.

Responsibilities

As your UK Responsible Person we will:

• Verify that devices sold in the UK carry the UKCA mark and that the appropriate medical device classification is utilized
• Verify UK declaration of conformity and technical documentation
• Ensure the declaration of conformity and technical documentation comply
• Maintain 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
• Provide the MHRA, as requested, with all the information and documentation necessary to demonstrate the conformity of a device
• 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
• Inform the manufacturer immediately about field incidents, complaints and reports from healthcare professionals, patients, and users about suspected incidents related to a device for which they (manufacturer) have been appointed
• Support Post Market Surveillance activities (Optional service)