What We Do

Regulation

Regulation has been the cornerstone of ABHI’s mission since its inception in 1988, and 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. As HealthTech becomes increasingly integrated across care pathways, combining devices, diagnostics and digital technologies, regulation must reflect how these technologies are developed, deployed and used in practice.

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 framework that supports UK-based research, development and manufacturing by reducing unnecessary complexity and enabling agile innovation.
  • Sufficient regulatory capacity to ensure companies, particularly SMEs, can bring products to market efficiently.

ABHI’s cross-sector approach to regulation reflects the reality that HealthTech does not operate in silos. By working across medical devices, diagnostics and digital health, we are able to address shared regulatory challenges such as classification, digitalisation and interoperability, while continuing to provide deep, sector-specific expertise where it is needed.

This approach strengthens the UK’s ability to respond to emerging technologies and evolving models of care. A coherent, joined-up regulatory system can uphold the highest safety standards while enabling innovation to be adopted more quickly and effectively across the NHS.

This commitment drives us to collaborate with a wide spectrum of stakeholders, both nationally, through work with the Medicines and Healthcare products Regulatory Agency (MHRA) and the Office for Life Sciences, and internationally, via participation in forums such as the Global Medical Technology Alliance and the International Medical Device Regulators Forum.

Our mission is twofold. First, we work closely with our members and stakeholders to help them navigate regulatory change, providing guidance, insight and practical support. Second, we seek to shape a regulatory environment that prioritises patient outcomes, supports economic growth and reflects the increasingly connected nature of HealthTech innovation.

As we outline in our 2025 paper, with the right regulatory framework in place, the UK has a generational opportunity to remain a powerhouse for HealthTech, creating high-value jobs, attracting investment and improving health outcomes for all.