EPF POSITION: In Vitro Diagnostics Regulation

Latest developments

 The in vitro diagnostics Regulation is currently being discussed in the Council, and we updated our position after a member consultation. The EPF position (see below) was sent to the Council this week.

Why are in vitro diagnostics important for our members?

In vitro diagnostic medical devices provide important information on medical conditions that may assist healthcare professionals and patients in delivering correct diagnosis, in monitoring the progression of an illness or impact of a prescribed treatment, and for screening. They are particularly important to the patient community as obtaining timely diagnosis is essential in many chronic and long term conditions.

While they usually do not pose direct risks to patients, ensuring the quality of these devices as well as education of healthcare professionals and information to patients is essential because healthcare decisions are taken based on the data these devices provide.

Key positive points in the European Parliament’s position which we would like the Council to keep in:

  • 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 negative points 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 among genetic condition, and there will be instances when genetic counselling is not necessary. We would welcome instead guidelines for 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 but written consent is not the only valid form of informed consent across Europe.

More information

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