How to get your IVD to meet UK regulatory standards

Bringing an in vitro diagnostic to market is about more than good science and technology. In the UK’s post-Brexit regulatory landscape, success depends on understanding how UKCA marking, MHRA requirements, evidence generation, and quality systems fit together, and where delays and risks commonly arise.

This practical guide, created by our regulatory experts, is designed for innovators developing IVDs. Whether you are an early-stage startup, a scaling SME, or an established organisation needing a UK regulatory refresher, it breaks down the UK regulatory pathway step-by-step, explains what's needed at each stage, and provides realistic timelines.

From classification and quality management systems to performance evidence, Approved Bodies, and MHRA registration, the guide helps you plan with confidence and avoid costly rework, so you can focus on getting your diagnostic into real-world use, faster.