The complex process of developing IVDs could become difficult and take a long time for most device manufacturers. IVD manufacturers are invited to act on time in order to be in compliance with the entry into force of the new Regulation.

Among the most important innovations, we can mention: changes to devices classification (many IVDs now in the residual category, therefore under self-declaration, will be subject to control by the Notified Body), obligation to establish a Responsible Person, execution of additional tests for the performance evaluation.