The proposed new standard provides guidelines on the conditions (means of delivery) and minimum required information which shall be physically delivered, when providing electronic instructions for use (eIFU) for in vitro diagnostic medical devices (IVDs).
Not in the scope of this standard: The content of the eIFU as it is covered by ISO 18113-1, -2, -3, -4, -5.
This document is applicable to the in vitro diagnostic manufacturers, the developer (investigators), and the users such as medical laboratories. It is also intended to be used by the organizations (e.g. regulatory authorities and conformity assessment bodies), which are responsible for assessing the performance and quality control.
Registration number (WIID)
88357
Scope
The proposed new standard provides guidelines on the conditions (means of delivery) and minimum required information which shall be physically delivered, when providing electronic instructions for use (eIFU) for in vitro diagnostic medical devices (IVDs).
Not in the scope of this standard: The content of the eIFU as it is covered by ISO 18113-1, -2, -3, -4, -5.
This document is applicable to the in vitro diagnostic manufacturers, the developer (investigators), and the users such as medical laboratories. It is also intended to be used by the organizations (e.g. regulatory authorities and conformity assessment bodies), which are responsible for assessing the performance and quality control.
