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.
Great Britain
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.
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