IVDR introduces 7 new, risk-based rules and highlights the fact that classification will be defined by the intended purpose.
The recent MDCG 2020-16 Guidance has shed some long-awaited light on the various aspects that need to be considered when classifying an IVD taking into account that >80% IVDs will require up-classification!
It is important to understand that under the new Regulation ALL classification and implementing Rules, as well as indents, must be considered for a proper classification.
Evnia’s advice: Start by the Implementing Rules and define the traits of your IVDs that must be considered. Continue with the 7 Classification Rules and provide a justification for each Rule you are rejecting.
Download the file here