InnoScot Health which has a strong record of protecting the interests of NHS Scotland, believes it is crucial for innovators to get the right regulatory advice, support, and signposting, and that understanding the implementation and transition plan for new medical device legislation is a key asset.

The session was introduced and led by Elaine Gemmell Head of Regulatory Affairs and Paula Sweeten, Project Manager. They were joined by Dr Paul Campbell, Senior Clinical Advisor, Software and AI, of the Innovative Devices Division at the Medicines and Healthcare products Regulatory Agency (MHRA).

Find out more about InnoScot Health’s regulatory advice service at

Video Chapters:

00:00 Introduction

03:05 Regulatory Landscape Overview (Elaine Gemmell)

26:31 Artificial Intelligence as a Medical Device (Dr Paul Campbell)

43:45 Question and Answer Session