UK Responsible Person

UK Responsible Person

Non-UK manufacturers of Invitro Diagnostic (IVD) devices are required to appoint a UK based Responsible Person (also known as UKRP) to support device registration. 

All devices must be registered by the UK Responsible Person on the MHRA Database before being placed on the market.

Supporting You


Help you understand the UK Requirements


Review your product technical files prior to registration


Register your devices and order Certificate of Free Sales


Provide on-market support and monitor regulatory changes

UK Regulatory Requirements

We will work with you to understand the UK regulatory requirements and register your devices on the MHRA database. Once your device is on market, we will support you from the UK for any post-market requirements.

We offer a transparent service to get you registered on the UK market, and help you understand any specific UK requirements now, and in the future.

We pride ourselves in developing long term relationships with our customers, and being their regulatory point of contact in the UK.

Please get in touch with us regarding our UKRP services, or you can fill out our simple questionnaire here to get started.

Our Responsibilities as a UK Responsible Person

  • Review technical documents and certificates and make sure they meet the requirements for the UK
  • Register and maintain devices on the MHRA database on behalf of the manufacturer
  • Be the point of contact for the MHRA for the Manufacturer
  • Support the Manufacturer with any post-market activity, including recalls