MHRA Notice on AI Airlock
The article provides a general overview of the new regulatory framework for innovative AI-based healthcare products intended to be marketed and used in the UK.
The article provides a general overview of the new regulatory framework for innovative AI-based healthcare products intended to be marketed and used in the UK.
The article describes the approach to be applied to innovative medical devices utilizing machine-learning technology.
The new article outlines the list of questions raised by the regulating authority in the context of the initiated consultation and also provides definitions of the most important terms and concepts used.
The new article describes in detail the new regulatory policy for in vitro diagnostic medical devices as suggested by the UK authority.
The article highlights the key points associated with the concept of common specification requirements for certain products allowed to be marketed and used in the UK.
The new article describes in detail certain specific aspects associated with registrations necessary to make submissions associated with healthcare products.