EU
The article describes in detail the approach to be followed in order to determine the regulatory status and applicable regulatory requirements.
EU
The article highlights the key points related to the regulatory status of legacy devices.
EU
The new article provides additional clarifications regarding specific aspects of the regulatory approach to be followed.
EU
The new article describes in detail specific aspects related to 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.
