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.
EU
The new article provides additional clarifications concerning the content of submissions associated with clinical investigations and modifications to it.
EU
The article provides an overview of the regulatory approach to be applied with respect to clinical investigations involving medical devices in the context of exemptions.
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