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.
EU
The article describes in detail the regulatory approach to be applied in the context of the importation and distribution of medical devices in the EU, focusing on the obligations of the parties involved.
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