Regulating Medical Devices in the UK

1. Overview of the Regulatory Framework The Medicines and Healthcare products Regulatory Agency (MHRA) is the executive agency responsible for regulating the medical devices market in the United Kingdom. The regulatory framework is primarily based on the UK Medical Devices Regulations 2002 (UK MDR 2002). Following the UK's exit from the European Union, the rules for placing devices on the market differ between Great Britain (England, Wales, and Scotland) and Northern Ireland. Source: Regulating medical devices in the UK

2. Great Britain Market Access (UKCA and CE Marking) To place a medical device on the market in Great Britain, manufacturers must meet specific marking requirements. The UKCA (UK Conformity Assessed) mark is the dedicated marking for the Great Britain market. However, the UK government has implemented transitional arrangements that allow for the continued recognition of CE marked devices for a defined period. Source: Regulating medical devices in the UK

2.1 Transition Timelines for CE Marked Devices Valid CE marks will continue to be recognized in Great Britain according to the following deadlines:

General medical devices compliant with the EU MDD or EU AIMDD can be placed on the market until 30 June 2028.

In vitro diagnostic medical devices (IVDs) compliant with the EU IVDD can be placed on the market until 30 June 2030.

General medical devices compliant with the EU MDR and IVDs compliant with the EU IVDR can be placed on the market until 30 June 2030. Source: Implementation of the future regulations (GOV.UK)

3. Northern Ireland Market Access Under the Northern Ireland Protocol, Northern Ireland maintains different requirements from Great Britain. To place a device on the Northern Ireland market, manufacturers must comply with EU regulations (EU MDR or EU IVDR). A CE mark is required. If a UK-based Notified Body is used for conformity assessment, a UKNI mark must accompany the CE mark. Source: Regulating medical devices in the UK

4. The UK Responsible Person (UKRP) Manufacturers based outside the United Kingdom who wish to place a device on the Great Britain market must appoint a single UK Responsible Person (UKRP). The UKRP must be physically based in the UK and assumes responsibilities related to the registration of the manufacturer’s devices with the MHRA and acting as a primary point of contact for the regulator. Source: Regulating medical devices in the UK

5. Device Registration Requirements All medical devices, including IVDs and custom-made devices, must be registered with the MHRA before being placed on the UK market. Registration must be performed by the UK manufacturer or the UK Responsible Person (for overseas manufacturers). There is a statutory fee for registration, currently set at £240 per application. Source: Register medical devices to place on the market (GOV.UK)

6. Role of Approved Bodies For certain classes of devices (Class IIa and above), a third-party conformity assessment is required. In the UK, these organizations are known as Approved Bodies. They perform assessments to ensure devices meet the requirements of the UK MDR 2002 for the purpose of affixing a UKCA mark. Source: Regulating medical devices in the UK