Medsafe
The new article explains the approach to be applied with respect to different categories of healthcare products based on specific criteria.
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.
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 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.
