Your UK Responsible Person

Umbilicus acts as the UK Responsible Person (UKRP) representing your medical device in the UK market. Umbilicus is a registered company in the UK, registered with the UK Competent Authority – Medicines & Healthcare products Regulatory Agency (MHRA) – to provide a UKRP service. We provide Responsible Person services for companies based outside of the UK who wish to sell medical devices in the UK market. It is mandatory for your UKRP to have a registered office in the UK.

The impact of Brexit

Following the United Kingdom’s withdrawal from the European Union on January 31, 2020, a number of very significant changes have been made to the process of importing medical devices and making them available for sale on the UK market, including changes to acceptance criteria for CE marked products and introduction of the UKCA mark. As your UKRP we will provide the necessary templates of the forms required to make an online registration on the MHRA portal, along with a checklist of required documentation.