EU
The new article outlines the scope of general information to be covered by a clinical investigation plan a party responsible for the inquiry should prepare.
EU
The new article describes the way study benefits and objectives should be reflected in a clinical investigation plan.
EU
The new article provides additional clarifications regarding study design and data management aspects.
EU
The new article highlights specific aspects of a clinical investigation plan, such as the approach to be followed concerning the deviations or informed consent and how it should be obtained before commencing a study.
EU
The article provides a general overview of a vigilance system applicable to CE-marked medical devices intended to be marketed and used in the EU and also highlights certain specific aspects associated thereto.
EU
The article provides a general overview of the regulatory concepts associated with demonstrating substantial equivalence for specific products intended to be marketed and used in the EU.
