There has been significant evolution in the European regulatory landscape over the past 10 years, particularly in terms of requirements for clinical evaluation, driven in part by
The UK’s MHRA recently published its guidance on its approach to both regulating the use of AI for drug and medical devices, and how it can utilise the technology to improve its regulating
Start-ups in the medtech space face many challenges on the way to market, not the least of which is how to prepare for, and comply with, medical device regulations.