MHRA Guidance on Software and AI
The article provides a general overview of the regulatory framework applicable to certain innovative products intended to be marketed and used in the UK.
The article provides a general overview of the regulatory framework applicable to certain innovative products intended to be marketed and used in the UK.
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.