MHRA (Medicines and Healthcare products Regulatory Agency)

The Medicines and Healthcare products Regulatory Agency (MHRA) is the United Kingdom’s (UK) authority that regulates the safety, quality, and efficacy of medicines, medical devices, and blood components for transfusion. First established in 2003, the MHRA operates under the Department of Health and Social Care.  

The MHRA acts as a scientific regulator and an enforcement body by gatekeeping product approvals and market access, and enforcing compliance once products are on the market. In the devices sector, the agency functions as the designated authority responsible for administering and enforcing medical device and IVD regulations across Great Britain and Northern Ireland.

In Great Britain, devices must comply with the UK Medical Devices Regulations (UK MDR 2002, as amended), as well as consumer protection laws, to obtain the UKCA (UK Conformity Assessed) mark, which is required to sell certain products, including medical devices, in Great Britain. In Northern Ireland, devices must obtain CE Marking in compliance with Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) under the Northern Ireland Protocol, supplemented by UK legislation.

MHRA employs a range of investigatory and enforcement powers that include issuing compliance, suspension, safety, and information notices; investigating adverse incidents, intelligence, or market surveillance reports; and recalling unsafe devices. The MHRA can take legal action against manufacturers, distributors, and other actors in the supply chain if products are deemed unsafe or non-compliant. In most cases, the agency works with companies to resolve issues without enforcement action.

The MHRA also oversees the designation and monitoring of UK Approved Bodies (the domestic counterpart to EU Notified Bodies), which conduct conformity assessments for higher-risk devices.  

Key Regulations Enforced by MHRA

In Great Britain:

• UK Medical Devices Regulations 2002 (SI 2002 No. 618, as amended)
• General Product Safety Regulations 2005 (SI 2005 No. 1803)
• Medicines and Medical Devices Act 2021 (MMD Act)
• Consumer Protection Act 1987 (applicable until certain MMD Act provisions come into force)
• Consumer Rights Act 2015 (enforcement powers)

In Northern Ireland:

• Regulation (EU) 2017/745 on Medical Devices (MDR)
• Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR)
• Medical Devices (Northern Ireland Protocol) Regulations 2021
• Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024
• Medicines and Medical Devices Act 2021 (MMD Act)
• Market Surveillance (Northern Ireland) Regulations 2021

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Website: UK MHRA
Address: MHRA, 10 South Colonnade, London, E14 4PU, United Kingdom
Phone: 020 3080 6000
Email: info@mhra.gov.uk

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