As part of the removal of the UK from the European Union from the 1st January 2021, the MHRA have laid down a new requirement for the appointment of a local natural or legal person to be responsible for the placement on the UK market of Medical Devices and IVDs where Legal Manufacturers do not have an establishment within the UK.
The new role is similar to the existing responsibilities of the EU Authorised Representative (AR) that is currently required for non-EU Legal Manufacturers to place devices onto the market in the EU under the IVD Directive. The use of the EU AR will continue under the new IVD Regulation from May 2022. The UKRP is responsible for registering devices with the MHRA, and acts as the first point of contact for MHRA, and customers within the UK market.
The UKRP shall also share a degree of liability with the Manufacturer for the devices that it places on the market. The need for a UKRP is a critical additional piece of the IVD supply chain for non-UK based manufacturers and it is important that these persons have sufficient quality and reliability to ensure effective compliance, safety and effectiveness of the devices on the UK market.
Joining the Directory
Signing up to the UKRP Directory page is free-of-charge for BIVDA member companies, and £199 plus VAT for non-members. Please follow the links below to join the page, and access BIVDA membership information.