Medical device regulatory challenges in the UK are affecting innovation and its potential benefits

The increase in regulatory challenges on medical technology developed and deployed in the UK is having a negative impact on innovation. In this paper we show how the limited capacity of Approved and Notified Bodies is one more barrier in the innovation pipeline, that could push more teams to consider applying for FDA approval instead of UKCA marking, potentially limiting how much our patients benefit from the world-leading research undertaken in UK universities.

Automated summary

The increase in regulatory challenges on medical technology in the UK is hindering innovation. The limited capacity of Approved and Notified Bodies serves as another barrier in the innovation pipeline, potentially leading more teams to seek FDA approval rather than UKCA marking, which may limit the benefits patients can receive from research conducted in UK universities.