We are delighted to offer our professional services and to support you with successful post-Brexit clearance in the United Kingdom.
In relation to the ongoing Brexit process, the regulatory landscape for medical devices and in-vitro diagnostic devices in the UK is significantly changing.
Current guidance from Medicines and Healthcare products Regulatory Agency (MHRA) requires non-United Kingdom based manufacturers to designate a United Kingdom Responsible Person (UKRP) from Jan 1st 2021. The UKRP is essentially an authorized representative established in the United Kingdom with the role to act as the manufacturer’s representative in the communication with the MHRA. This is required for both new medical devices or to continue to place current medical devices on the UK market.