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.
EU
The article highlights the aspects related to studies involving combination products, the ones not initially intended to assess the safety and performance of a medical device, and other specific cases.
EU
The article briefly overviews the European regulatory framework for clinical investigations.
