What is... the MHRA?

A guide to the Medicines and Healthcare products Regulatory Agency for legal professionals, clinicians, and expert witnesses

When discussing healthcare regulation in the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) plays a central role in patient safety, public health, and clinical governance. It is a name often mentioned in the context of drug licensing, device recalls, and compliance with safety standards, yet many outside the regulatory or pharmaceutical sectors have only a general idea of its function.

This article provides a clear overview of what the MHRA is, what it does, and how its work intersects with clinical practice and medico-legal matters — particularly relevant for clinicians, legal teams, and expert witnesses working in areas involving drugs, medical devices, and treatment outcomes.

What is the MHRA?

The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the UK government. It operates under the Department of Health and Social Care (DHSC) and is responsible for regulating medicines, medical devices, and blood components for transfusion in the United Kingdom.

The MHRA ensures that these products are safe, effective, and high-quality, and that they are manufactured, distributed, and used in compliance with legal and ethical standards.

Key Functions of the MHRA

1. Licensing and Authorisation of Medicines

Before a new medicine can be marketed in the UK, the MHRA must assess its safety, efficacy, and quality. If it meets the required standards, the agency will issue a marketing authorisation (licence).

This process includes:

• Reviewing clinical trial data

• Evaluating side effect profiles

• Assessing manufacturing and labelling standards

The MHRA also monitors licensed products for post-marketing safety through a pharmacovigilance system.

2. Medical Device Regulation

All medical devices — from surgical implants to digital health apps — must meet UKCA marking standards (post-Brexit, this replaces CE marking in the UK context). The MHRA oversees:

• Device classification and safety requirements

• Post-market surveillance

• Reporting and investigation of device failures or defects

3. Pharmacovigilance and Safety Monitoring

The MHRA operates the Yellow Card Scheme, allowing patients and healthcare professionals to report suspected side effects or device malfunctions. The agency analyses this data to identify safety concerns and, where necessary, issues alerts, recalls, or updated guidance.

4. Clinical Trials Regulation

The MHRA is responsible for granting approval to conduct clinical trials of investigational medicinal products (CTIMPs) in the UK. It ensures trials are ethical, scientifically valid, and compliant with regulatory standards.

5. Enforcement and Inspection

The agency has powers to inspect manufacturers, wholesalers, and trial sites. It can:

• Seize unlicensed or falsified medicines and devices

• Prosecute for breaches of legislation

• Suspend or revoke licences

MHRA and Medico-Legal Relevance

While the MHRA is not a direct party in legal claims, its guidance and regulatory decisions frequently underpin medico-legal arguments — especially in cases involving product liability, clinical negligence, or informed consent.

Legal teams may refer to MHRA standards to:

• Establish the standard of care regarding drug or device use

• Examine whether a product had appropriate warnings or instructions

• Identify any safety alerts or recalls that were not acted upon by clinicians

• Support causation arguments where adverse outcomes link to product failure

In expert witness work, references to MHRA guidelines can help contextualise whether the actions taken by a clinician or organisation met the expected regulatory framework at the time of the incident.

Recent Developments

Since the UK’s exit from the European Union, the MHRA now has greater independence in shaping its own regulatory policies. Key changes include:

• Transition from EU CE marking to UKCA marking for devices

• Introduction of the Innovative Licensing and Access Pathway (ILAP) to speed up drug approvals

• Proposals for a more risk-proportionate and streamlined approach to device approvals

• Increased focus on real-world data and digital health technologies

Final Thoughts

The MHRA plays a vital role in upholding patient safety, clinical integrity, and regulatory accountability in the UK health system. For legal professionals and expert witnesses, familiarity with its role is essential — especially when working on cases involving adverse drug reactions, faulty devices, or delayed action on known safety concerns.

Understanding MHRA guidance is not just about compliance — it helps define the legal landscape in which healthcare is delivered and assessed.

Need an expert witness to comment on device safety, medicine interactions, or regulatory compliance?Contact info@apexexperts.co.uk or visit www.apexexperts.co.uk for expert CVs, guidance, or case support.