UK Legal Framework for In Vitro Diagnostic Medical Devices

1. Legislative background

In vitro diagnostic medical devices (IVDs) placed on the UK market are regulated under UK medical devices legislation, which largely retains and adapts the former EU framework following the UK’s exit from the European Union. The primary legal instrument applicable to IVDs is the UK Medical Devices Regulations 2002, as amended, which continue to reflect the structure and concepts of the former EU IVD Directive during the transition period. Oversight and enforcement are carried out by the Medicines and Healthcare products Regulatory Agency (MHRA). Source: In vitro diagnostic medical devices: guidance on legislation

2. Scope and definition of IVDs

Under UK legislation, an in vitro diagnostic medical device is defined as a medical device intended for the examination of specimens derived from the human body, including blood and tissue donations, to provide information concerning:

• A physiological or pathological state
• A congenital abnormality
• The safety and compatibility of potential recipients
• The monitoring of therapeutic measures

This definition also extends to specimen receptacles and certain accessories specifically intended for diagnostic use. Source: In vitro diagnostic medical devices: guidance on legislation

3. Classification of IVDs

UK legislation classifies IVDs into categories that determine the level of regulatory control and conformity assessment required. These include:

• General IVDs
• IVDs for self-testing
• IVDs listed in Annex II (List A and List B), which are considered higher risk due to their public health impact

The classification influences whether a notified body must be involved in conformity assessment and the extent of regulatory scrutiny prior to placing the device on the market. Source: In vitro diagnostic medical devices: guidance on legislation

4. Conformity assessment and UKCA marking

Before an IVD can be placed on the UK market, the manufacturer must demonstrate compliance with the essential requirements set out in legislation. Depending on the classification:

• Manufacturers of lower-risk IVDs may self-declare conformity
• Higher-risk IVDs and self-test devices generally require assessment by a UK-approved body

Compliant devices must bear the UKCA marking (or, during applicable transitional arrangements, alternative accepted markings), indicating conformity with UK legal requirements. Source: In vitro diagnostic medical devices: guidance on legislation

5. Registration with the MHRA

All IVDs placed on the UK market must be registered with the MHRA. Registration obligations apply to manufacturers, UK responsible persons, and importers, depending on where the manufacturer is established. Registration provides the MHRA with oversight of devices on the market and supports post-market surveillance and enforcement activities. Source: In vitro diagnostic medical devices: guidance on legislation

6. Post-market surveillance and vigilance

Manufacturers and other economic operators have ongoing obligations after market placement, including:

• Monitoring device performance and safety
• Reporting serious incidents and safety corrective actions to the MHRA
• Taking appropriate corrective or preventive measures when risks are identified

These post-market requirements are essential to ensure continued compliance and protection of public health throughout the device lifecycle. Source: In vitro diagnostic medical devices: guidance on legislation

7. Transition and future regulatory developments

The guidance also notes that the UK is progressing toward a new, standalone regulatory framework for medical devices, including IVDs. During the transition period, manufacturers may rely on existing rules while preparing for future changes, and are encouraged to monitor MHRA updates to ensure timely compliance with evolving requirements. Source: In vitro diagnostic medical devices: guidance on legislation