
EU Q&A on Information Obligations Associated with Interruption or Discontinuation of Supply
The article highlights the key points related to the manufacturers’ obligations in case of product supply being interrupted or discontinued.
The article highlights the key points related to the manufacturers’ obligations in case of product supply being interrupted or discontinued.
The new article describes in detail specific aspects related to the reporting requirements associated with performance studies involving in vitro diagnostic medical devices.
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.
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.