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Our position on In Vitro Diagnostic devices’ review is out

EPF released a position paper on In Vitro Diagnostic (IVD) medical devices, a specific type of device. They comprise all tests performed on patients to provide a diagnosis, either through a test tube or through devices for self-testing.

“IVDs 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 the predisposition toward a disease”, said Laurène Souchet, EPF Policy Officer.

She continues: “We believe that the review of the IVD legislation is a key opportunity to empower patients through increased transparency on the safety of the devices and better access to quality information about these devices. This is particularly crucial for devices sold directly to the consumers, genetic tests, self-tests and patients tests. Patients need to have information on reliability of these tests, their use, how to interpret the results.


The key points of our position are as follow:

  • EPF is concerned by unreliable direct-to-consumer sale of genetic tests sold on the EU market. We trust that the best solution would be to regulate this practice rather than ban it, as suggested by MEP Peter Liese.
  • For all genetic tests: The Regulation should refer to the Additional Protocol to the Convention on Human Rights and Biomedicine developed by the Council of Europe, which developed key principles regarding the quality of genetic testing services.
  • For self-tests devices: All self-testing devices should be developed with the aim to empower patients. The clear expectation is that the use of these devices should improve diagnosis and potential outcomes at an acceptable cost.
  • Information to patients has a particular importance in the case of IVDs as the proposal for a Regulation provides for new requirements to ensure patients are aware of the risk of failure and are advised to consult their healthcare professional before taking a decision of medical relevance. We however request further provisions to provide patients with the high quality information they need. 

To read the full position paper, please follow this link.

For more information, please email Laurène Souchet, EPF Policy Officer, at laurene.souchet@eu-patient.eu.