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

If you’re a medical device or IVD manufacturer without a registered office in the UK, you must appoint a local representative, your UKRP. Your UKRP is responsible for managing your device registration as well as any relevant Importer relationships and liaising with the MHRA on your behalf.

Identify any natural or legal person established within the UK who is willing to act in this capacity and is willing/able to sign a legally binding agreement appointing themselves as your UK Responsible Person.

One of the key differences between the UK Responsible Person and the Importer has to do with exposure. Your contract with your Responsible Person takes into account the fact that they can be held legally liable for your defective devices sold in the UK per (a reference to be provided). Similarly, your Importer has significant exposure in that they can be held financially liable for your non-compliance with the MDR.

Medical devices, and In Vitro Diagnostics (IVDs), are regulated by the Medicines and Healthcare products Regulatory Agency
(MHRA). Since January 1, 2021, the MHRA has made significant changes to how medical devices and IVDs are regulated in the UK. The most important change is that all devices must be registered with the MHRA before they are placed onto the market. For manufacturers outside the UK, a UK Responsible Person (UKRP) must be appointed to act and register on behalf of the manufacturer. Prior to formally registering, all manufacturers will either need to have Conformitè Europëenne (CE) Marking, which will be
recognized by the MHRA until June 30, 2023, OR obtain UK Conformity Assessed (UKCA) Marking.

Only if UKCA marked.
In case the devices are only CE-marked, it is not required to include the UKRP information on the European DoC. However, in case the devices are already UKCA-marked, the UKRP information does need to be included in the UK DoC.