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 new article provides additional clarifications concerning the content of submissions associated with clinical investigations and modifications to it.
EU
The new article highlights the aspects related to the timelines associated with the clinical investigations, the way they should be calculated, and other relevant matters.
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices’ regulations, has published a guidance document dedicated to the integration of the UDI within an organization’s quality management system. Table...
MDCG
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission comprised of the representatives of all Member States, has published a guidance document dedicated to harmonized administrative practices and alternative technical solutions...
