Result card

  • LEG14: Do Genetic Tests (uPA/PAI-1 ELISA/ Oncotype DX/ MammaPrint) fulfill product safety requirements?
No adaptation help available for this domain

Do Genetic Tests (uPA/PAI-1 ELISA/ Oncotype DX/ MammaPrint) fulfill product safety requirements?

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.

Since there are not yet any specific EU Directives relating to the safety requirements of the three tests (uPA/PAI-1, Oncotype DX, MammaPrint), it is necessary to make analogical references to norms such as Directive 2001/20/CR of the European Parliament and the Council from 4 April 2001 regarding the application of good clinical practices in the execution of clinical experimentation of medicines for human use{30}; Directive CEE/CEEA/CE 79 from 27/10/1998 98/79/CE: Directive of the European Parliament and the Council from 27 October 1998 relating to in vitro medical diagnostic devices{21}, that indicate all the requirements for the use of medicines for human use in a way that truly respects human dignity and that establishes the essential requirements needed to guarantee the quality, safety and good performance of the in vitro device placed in the European market.

Thereof, the essential requirements determined in Annex I of the In Vitro Diagnostic Device IVDD concern:

A. Safety and performance general requirements;

B. Design and manufacturing requirements:

  • chemical and physical properties
  • infection and microbial contamination
  • manufacturing and environmental properties
  • devices which are instruments or apparatus with a measuring function
  • protection against radiation
  • requirements for medical devices connected to or equipped with an energy source
  • requirements for devices for self-testing
  • information supplied by the manufacturer

The presumption of conformity with the essential requirements is achieved by the implementation of technical specifications given by European harmonised standards. Harmonised standards are European standards, which are adopted by European standards organisations, prepared in accordance with the General Guidelines agreed between the Commission and the European standards organisations, and follow a mandate issued by the Commission after consultation with the Member States.

Casini M et al. Result Card LEG14 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 (, Italy ; 2013. [cited 2 December 2022]. Available from: