EU
The new article provides an in-depth overview of the reporting requirements associated with performance studies involving in vitro diagnostic medical devices.
EU
The article highlights the key points related to the regulatory framework for reporting requirements in the context of certain studies medical devices are subject to.
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.
EU
The article highlights the key points associated with interpreting specific regulatory provisions of the current European legislation in medical devices.
CHMP
The article highlights the key points associated with the regulatory framework for specific categories of medicinal products.
