What We Do

Regulation has been the cornerstone of ABHI's mission since its inception in 1988, and to this day, it remains at the forefront of our work. We recognise that regulation not only underpins patient safety but also plays a pivotal role in shaping how the United Kingdom is perceived as a hub for healthcare innovation and investment.

The significance of regulation in healthcare cannot be overstated. It forms the foundation upon which the trust of patients, healthcare professionals, and investors is built. Predictable and transparent regulatory requirements are not just desirable; they are essential for the successful operation of any market. As the UK establishes its future regulatory framework, it has a unique opportunity to build a system that is patient-centred, globally competitive, and innovation-friendly. This means ensuring:

• Timely and predictable approvals that allow patients to access innovative HealthTech solutions without delay.
• Regulatory alignment with key global markets to support international trade and investment.
• A system that fosters UK-based research, development, and manufacturing by reducing unnecessary complexity and supporting an agile innovation ecosystem.
• Capacity within the UK regulatory system to ensure companies, especially SMEs, can bring products to market efficiently.

We firmly believe that the United Kingdom has a generational opportunity to drive innovation and growth within our healthcare sector. A world-class regulatory framework can uphold the highest safety standards while empowering home-grown businesses to expand their global presence. By doing so, the UK can strengthen its position as a leading destination for HealthTech investment.

This commitment drives us to collaborate with a wide spectrum of stakeholders, both at the national level - through partnerships with the Medicines and Healthcare products Regulatory Agency (MHRA) and the Office for Life Sciences - and on the global stage, through participation in forums like the Global Medical Technology Alliance and the International Medical Device Regulators Forum.

Our mission is twofold. Firstly, we work closely with our members and stakeholders to help them navigate regulatory change, providing guidance, insights, and resources to ensure they can adapt and thrive. Secondly, we are dedicated to shaping a regulatory environment that prioritises patient well-being, supports economic growth, and fosters a culture of innovation.

As we outline in our January 2025 paper, with the right regulatory framework, we can ensure the UK remains a powerhouse for medical technology, creating high-value jobs, attracting investment, and improving health outcomes for all.