Medsafe
The new article explains the approach to be applied with respect to different categories of healthcare products based on specific criteria.
AIaMD
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.
EU
The article provides a general overview of the existing legal framework for special authorized bodies undertaking special functions with respect to medical devices.
EU
The new article elaborates further on the matters related to on-site assessment activities to be undertaken in the context of the designation process.
BfArM
The article provides an overview of the authorization process for clinical trials involving medical devices to be conducted in Germany.
Canada
The article describes the approach to be applied to innovative medical devices utilizing machine-learning technology.
