IVD development regulatory checklist for SMEs

Developing an in vitro diagnostic (IVD) can be complex, time-consuming, and high risk, particularly for SMEs navigating UK and EU IVD regulatory requirements for the first time.

This practical guide cuts through that complexity, bringing together the essential steps needed to sanity-check an IVD development plan before committing significant time or capital. From defining a clear clinical value proposition to preparing regulator-ready technical documentation, the checklist helps teams avoid costly redesigns, strengthen investor confidence, and create a smoother route to UKCA and CE marking.

It is an essential starting point for any IVD innovator looking to accelerate product development, reduce regulatory risk, and reach the market faster with confidence.