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 highlights the aspects related to the general principles of clinical evaluation.
The article provides an overview of the provisions of a guidance document and highlights the key points to be taken into consideration by medical device manufacturers (software developers).
This article describes Software Based Medical Devices and their key regulatory considerations. Table of Contents Software is now a crucial component of every product as technology continues to develop all elements of health care. It is widely integrated into digital...
The article describes the approach to be applied when determining the regulatory status of a borderline product that could be subject to regulation under the medical devices framework, and also pays special attention to the applicable risk-based classification. Table...