Does the introduction of Genetic Tests (uPA/PAI-1 ELISA/ Oncotype DX/ MammaPrint) presume some additional licensing fees to be paid?
Authors: Marina Casini, Emanuela Midolo, Marco Marchetti
Internal reviewers: Judite Neves, Ana Bação, Vesna Kovač
The domain methodology used for this question has been collection, selection and analysis of European norms and sentences.
As these tests do not presume the need of Notified Body assessment (which is paid) in this context there is no associated fee.
Nevertheless, there are some Member States that require registration fees for all medical devices.
Casini M et al. Result Card LEG17 In: Casini M et al. Legal aspects In: Jefferson T, Vicari N, Raatz H [eds.]. Prognostic tests for breast cancer recurrence (uPA/PAI-1 [FEMTELLE], MammaPrint, Oncotype DX ) [Core HTA], Agenzia nationale per i servizi sanitari regionali (age.na.s), Italy ; 2013. [cited 3 December 2022]. Available from: http://corehta.info/ViewCover.aspx?id=113