What is UK Responsible Person (UKRP)

For manufacturers based outside of the UK, a UKRP must be assigned who will take responsibility for registering the company’s medical devices with the MHRA before they are sold on the UK market.

The UKRP can be any third-party entity, or an importer or distributor that acts on the manufacturer’s behalf.

In addition to acting as the key point of contact with the MHRA on behalf of the manufacturer, the UKRP must ensure that all technical documentation has been drawn up appropriately and inform the manufacturer about any complaints or adverse incidents that occur in the UK.

Overseas manufacturers need to appoint a UKRP to register their device with the MHRA. The manufacturer is responsible for providing the UKRP with all proper documentation, including a written letter of designation, and must advise them of the details of the importers of all their products. The manufacturer must also ensure the UKRP registers their product correctly and before any deadlines.

The address of the UKRP must appear on device labelling alongside the UKCA mark itself.

Further details can be found on: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk