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.
EU
The article provides a general overview of the regulatory approach to be applied with respect to certain CE-marked devices.
