Regulation (EU) 2017/746 on in vitro diagnostic medical devices came into force on May 26, 2022. Among the novelties introduced by this regulation, the classification system has been modified to be based on the risks related to the destination of the device, and the Notified Bodies’ role has been strengthened.
Indeed, while most in vitro diagnostic medical devices did not require the intervention of a Notified Body under Directive 98/79/EC, it is estimated that with the application of the new classification rules, 80% of in vitro diagnostic medical devices are subjected to an assessment by a Notified Body before being placed on the market under Regulation (EU) 2017/7461. This includes several types of software used in in vitro diagnostics.
In addition, Regulation (EU) 2017/746 on in vitro diagnostic medical devices now includes safety and performance requirements specific for in vitro diagnostic medical device software.
This newsletter provides an overview of the consequences of the application of Regulation (EU) 2017/746 on software used in in vitro diagnostics.