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

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

When was the UK MHRA established?

MHRA was established on April 1, 2003 by combining the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA) into a single agency.

Does UK MHRA charge fees for medical devices?

Yes, MHRA charges fees for a broad range of regulatory oversight activities, from device registrations, inspections, advice meetings, and more. The full fee schedule is available here.

How does the MHRA regulate medical devices?

In Great Britain, devices are regulated under the UK Medical Devices Regulations 2002 (UK MDR 2002, as amended). The UKCA route is available, but qualifying CE-marked devices continue to be accepted during statutory transition periods. Under current rules, devices certified under the EU MDD or AIMDD may generally be placed on the Great Britain market until the sooner of certificate expiry or 30 June 2028; devices certified under the EU MDR, and IVDs compliant with the EU IVDD or IVDR, may generally be placed on the market until 30 June 2030. Eligibility and dates depend on the specific device and certificate. In Northern Ireland, EU MDR and IVDR rules continue to apply, with UKNI marking required in certain conformity-assessment situations. Verify the current pathway in the MHRA's official guidance on regulating medical devices in the UK.

What key medical device regulations are enforced by the 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

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