
MHRA Guidance on Software and AI as a Medical Device
The article provides an overview of the regulatory approach to be applied with respect to certain categories of innovative medical devices.
The article provides an overview of the regulatory approach to be applied with respect to certain categories of innovative medical devices.
The new article provides an overview of the regulatory approach to medical devices allowed for marketing and use in the United Kingdom.
The new article elaborates further on special considerations associated with clinical investigations involving medical devices intended to be marketed and used in the UK, highlighting the most important aspects.
The new article describes in detail the approach to be followed when deciding whether clinical investigations are necessary and also elaborates more on the circumstances associated thereto.
The article provides a general overview of the UK regulatory framework for clinical investigations related to medical devices intended to be marketed and used in the country.