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 article provides a general overview of the regulatory approach to be applied with respect to certain CE-marked devices.
HPRA
The article highlights the key points related to the current regulatory framework for clinical investigations conducted in Ireland.
