EPF liaises with the Council on In Vitro Diagnostics Regulation

In Vitro Diagnostic (IVD) medical devices comprise all tests performed on patients to provide a diagnosis, either through a test tube or through devices for self-testing. They are important to the patient community as they provide information on medical conditions that may assist doctors with providing a correct diagnosis, monitoring the progression of an illness, or, in some cases, determining predisposition toward a disease.

We call on the Council to retain the following key positive points in the European Parliament’s position:

  • Measures to ensure better information and transparency to patients on in vitro diagnostics devices,
    • in particular new information requirements for self-testing and near patient testing devices (devices that are used by healthcare professionals, not in a laboratory environment),
    • transparency through summary of safety and performance report for In vitro diagnostics devices that are in the higher risks categories.
    • Measures on clinical performance studies that aim at ensuring better patient involvement in the assessment of the study, and particularly in ethics committees.
    • More transparency on clinical performance studies’ outcomes through a layperson summary of the results.

Key EP proposals that we would like to see changed:

  • The European Parliament included provisions for mandatory genetic counselling after a genetic condition has been diagnosed. We do not support this provision, as there are different risks brackets within genetic conditions, and there will be instances when genetic counselling is not necessary. We would welcome instead guidelines on genetic counselling, drafted with involvement of healthcare professionals societies.
  • The European Parliament asks for patients to give written consent before a genetic test. EPF believes informed consent is essential however written consent is not the only valid form of informed consent across Europe.

For more information, please contact Laurène Souchet, EPF Policy Officer (laurene.souchet@eu-patient.eu).