How Regulation Shapes the UK Health Economy: The Distinct Functions of the HRA and MHRA

What is the difference between HRA and MHRA in the UK?

The healthcare and research sector in the United Kingdom is one of the most advanced and strictly regulated in the world. However, for those unfamiliar with the regulatory framework, the acronyms HRA and MHRA can be confusing. In reality, both refer to crucial bodies, but their missions and responsibilities are fundamentally different.

If your company works in clinical research or if you are looking to introduce a medical device into the UK market and require a UK representative medical devices, it is essential to understand the role of each institution. Put simply, one focuses on ethics and research, while the other ensures the safety and commercialisation of medicines and medical devices.

Understanding the distinction between them is the first step to ensuring legal compliance and success in this important market.

The Ethical Guardian: the Health Research Authority (HRA)

The Health Research Authority (HRA), established in 2011, focuses almost exclusively on the field of clinical research. Its primary mission is not to regulate the safety of medicines or products already on the market, but to ensure that all health research carried out within the National Health Service (NHS) is ethical and well-designed.

Functions of the HRA

Ethical review of studies: the HRA manages the Research Ethics Committees (RECs) that review the protocols of all studies involving the NHS. Their approval certifies that the rights, safety, dignity and well-being of research participants are protected.
Governance approval: the HRA also grants HRA Approval and NHS permission, ensuring the study’s governance is appropriate. Without this approval, research simply cannot begin.
Transparency: it promotes full transparency in research, ensuring clinical study results are made public, whether positive or negative.

In essence, the HRA acts as the ethical guardian of research. If a study is safe and if a medicine or device should be tested on humans in a research setting, it is the HRA that gives the green light.

The Market and Safety Watchdog: the Medicines and Healthcare Products Regulatory Agency (MHRA)

The Medicines and Healthcare Products Regulatory Agency (MHRA) has a much broader mandate. It is the government body responsible for ensuring that medicines and medical devices work effectively and are acceptably safe for public use in the UK.

Functions of the MHRA

Licensing and market authorisation: it grants licences for medicines and authorises the sale of medical devices. No medicine or device can be legally sold in the UK without prior MHRA approval.
Pharmacovigilance and technovigilance: it monitors the safety of products once they are on the market. It collects and evaluates reports of adverse effects (medicines) or incidents (devices) to take corrective action when needed.
Inspection and compliance: it conducts inspections to ensure that manufacturers and distributors meet Good Manufacturing Practice (GMP) standards and post-Brexit regulatory requirements.

The MHRA is therefore the market regulator, focused on product safety and quality before and during commercialisation.

Key Difference: Ethics vs. Market

The distinction can be summarised in a few words:

HRA: focuses on research ethics. It asks: Should we conduct this study, and are participants being treated properly?
MHRA: focuses on product safety and market approval. It asks: Is this medicine/device safe and effective for public sale?

A new medicine, for example, requires HRA Approval to begin clinical trials in humans, and later requires MHRA Licensing to be sold in pharmacies and hospitals.

Both bodies are essential for the integrity of the healthcare system, but operate at different stages in a product’s lifecycle.

The UK RP: the Mandatory Link for Medical Device Compliance

Following the UK’s exit from the European Union, the medical device market underwent a major regulatory shift. All manufacturers based outside the UK (EU, US, Asia, etc.) who want to market devices in Great Britain must now appoint a UK Responsible Person (UK RP).

What Is the UK RP and Why Is It Mandatory?

The UK RP is a legal entity or individual established in Great Britain who acts as the mandatory point of contact between the non-UK manufacturer and the MHRA. It is essentially the legal extension of the manufacturer within the UK.

This requirement exists because the MHRA needs a legally accountable contact for all matters related to device compliance.

The UK RP must also ensure that the technical documentation and the Declaration of Conformity are readily available for the MHRA upon request.

Without appointing a UK RP and registering devices with the MHRA, no foreign manufacturer can legally sell medical devices in Great Britain.

Functions of the UK RP

Register the devices with the MHRA database within the required timeframe.
Act as the MHRA’s primary contact during inspections, safety alerts or product-related inquiries.
Maintain a copy of the technical documentation and demonstrate that the manufacturer meets the requirements for the UKCA marking.
Assist the manufacturer with incident reporting and safety notifications to the MHRA.

How to Choose a UK RP

Choosing a UK RP is a strategic decision, as it involves selecting a partner responsible for your legal compliance and your brand’s reputation in the UK market.

The choice should be based on regulatory expertise, financial stability, and the ability to respond immediately to MHRA requests. It is also crucial that the UK RP has in-depth knowledge of post-Brexit regulations and the evolving UKCA system.

A good UK RP is not just a legal requirement. It is a strategic advisor who helps you navigate the complex world of UK medical device compliance.

The MHRA and the HRA play complementary but very different roles:

The HRA safeguards ethics in research.
The MHRA protects the public from unsafe or ineffective medical products.

Additionally, for any international company, entering the UK market requires the mandatory appointment of a UK RP, who acts as the guarantor that devices meet the UK’s strict safety and quality standards.

Ensuring you work with a competent UK RP and fully understanding the role of each authority is essential for operating successfully and responsibly in the British healthcare sector.