UK Medical Device and IVD Registration: The UKCA Transition and UK Responsible Person Requirements

Medical Device and IVD Registration in Great Britain (GB)

[cite_start]The Medicines and Healthcare products Regulatory Agency (MHRA) is the regulatory body responsible for medical devices and In Vitro Diagnostic (IVD) devices in the UK, particularly within Great Britain (England, Wales, and Scotland)[cite: 1, 23].

Key Market Requirements for Great Britain

[cite_start]All medical devices, including IVDs, custom-made devices, and systems or procedure packs, must be registered with the MHRA before being placed on the GB market[cite: 121].

1. The UK Responsible Person (UKRP)

[cite_start]Manufacturers based outside the UK are considered "third country" manufacturers and must appoint a UK Responsible Person (UKRP)[cite: 105, 106].

• [cite_start]Role: The UKRP acts on the manufacturer's behalf, with a role similar to the Authorized Representative in the EU[cite: 111, 113].
• [cite_start]Registration Duty: The UKRP must register the manufacturer, the importer, and all applicable devices with the MHRA[cite: 123].
• [cite_start]Importer Requirement: Devices from non-UK manufacturers must also be placed on the market by a UK-established importer[cite: 106, 107].

2. Conformity Marking and Transition

[cite_start]The new mandatory conformity mark for the GB market is the UK Conformity Assessed (UKCA) marking[cite: 142].

• [cite_start]CE Mark Acceptance: The GB market will remain open for CE-marked medical devices and IVDs until, at the latest, June 30, 2030, depending on the device type and classification[cite: 86, 140].
• [cite_start]Labelling: The name and address of the UKRP must be indicated on the product label, outer packaging, or instructions for use, but only in cases where the UKCA marking has been affixed (including dual-marked devices)[cite: 146].

3. MHRA Registration Process

[cite_start]Registration with the MHRA is necessary for market surveillance[cite: 120].

• [cite_start]Process: The UKRP is required to complete the registration process on behalf of the non-UK manufacturer[cite: 122, 125].
• [cite_start]Classification: Devices are registered as a device family based on the Global Medical Device Nomenclature (GMDN) code, not the EMDN code used for EUDAMED[cite: 127, 128].
• [cite_start]Fee: A fee of £240 applies for each application, which can cover up to 100 devices with a cumulative maximum of 20,000 products[cite: 129, 130].

Note: This guidance primarily relates to the Great Britain market. [cite_start]Northern Ireland has a special status, with CE marking remaining applicable due to the Northern Ireland Protocol[cite: 159, 167].