Overview of the Medicines and Healthcare products Regulatory Agency (MHRA) and Medical Device Regulation in the UK

Introduction

The Medicines and Healthcare products Regulatory Agency (MHRA) is the executive agency of the Department of Health and Social Care responsible for regulating the UK medical devices market.

Role and Responsibilities

The MHRA's core functions include:

• Market Surveillance: Monitoring the safety and performance of medical devices on the UK market.
• Enforcement: Taking decisions over the marketing and supply of devices in the UK.
• Designation of Bodies: Appointing and monitoring UK conformity assessment bodies (Approved Bodies).
• Vigilance: Managing the reporting of adverse incidents and field safety corrective actions.

Key Regulatory Requirements

• Registration: All medical devices, including IVDs and custom-made devices, must be registered with the MHRA before being placed on the Great Britain market.
• UKCA Marking: The UKCA (UK Conformity Assessed) marking is the mandatory product marking for devices in Great Britain (transitional recognition of CE marks is currently in place).
• UK Responsible Person (UKRP): Manufacturers based outside the UK must appoint a UKRP to act on their behalf and manage registrations.
• Northern Ireland: Under the Northern Ireland Protocol, EU rules (MDR and IVDR) apply, and devices require CE marking.

Post-Market Surveillance

Manufacturers must ensure continuous compliance and report incidents to the MHRA. Recent legislation has strengthened these requirements to facilitate better risk management.