Regulation on In Vitro Diagnostic Medical Devices- EPF’s Verdict


On May 25, the new Regulation on in vitro diagnostic medical devices was adopted. EPF welcomes the updated legislation, in particular in relation to its stronger provisions for patient safety and information to patients. We can, however, only regret the very limited provisions on patient involvement.

In vitro diagnostic (IVD) medical devices are essential for patients as they provide information helping healthcare professionals to establish a correct diagnosis, monitor the progression of an illness, and treatment’s response. IVD devices encompass testing methods based on a biological substance provided by a patient, and devices for self-testing such as blood glucose monitoring devices for diabetes.

  • Patient Safety and Quality of Care

Many healthcare decisions are taken based on the data provided by IVD devices. Ensuring the quality of these devices is therefore essential.

The Regulation takes measure to strengthen the collection and assessment of clinical evidence. It also offers provisions to improve vigilance and in particular requires Member States to empower patients to directly report incidents related to the use of in vitro diagnostic devices.

An important safety issue for the patient community is the reliability of tests sold directly to patients on the Internet. The Regulation makes it clear that devices available online must comply with the provisions of the Regulation, and a competent authority can require the EU declaration of conformity to be provided.

In its position published in 2013, EPF advocated for the possibility for healthcare institutions to develop, use or modify in-house tests to respond to the needs of specific groups of patients, while ensuring the quality of these tests. We are happy to see that the Regulation makes this possible provided it is not on an industrial scale, and that it addresses specific needs which cannot be met by devices available on the market.

  • Transparency and Information to Patients

Information to patients and healthcare professionals is essential for in vitro diagnostics devices in order to interpret the results of tests accurately.

We strongly welcome the stricter requirements for information to be provided to patients, in particular for self-tests and near patients testing. For devices in higher risks categories, the manufacturer has to draw up a summary of safety and performance and make it publicly available with understandable information.

The new Regulation also clarifies provisions related to the informed consent during clinical investigations. It sets rules to ensure that patients are provided with appropriate information to give their informed consent when taking a genetic test, and that they are provided with counselling for tests which provide information on the genetic predisposition for medical conditions and/or diseases which are generally considered to be untreatable according to the state of science. This goes in the right direction, as EPF had advocated for avoiding to treat all genetic conditions as similar in risk and to draw up guidelines with healthcare professionals at national level to define when genetic counselling is necessary.

  • Patient Involvement

Provisions on patient involvement are similar as these adopted in the Regulation on Medical Devices. It is particularly disappointing to note that the final agreement fails to integrate a proposal from the European Parliament to involve patients and healthcare professionals in the review of instruction for use as advocated by EPF to ensure information is tailored to the needs of users.

  • Next Steps

The date is not yet known, but the new rules will be officially published in the first months of 2017, and be applicable 5 years after their publication. 


Contact person:

Laurène Souchet, Policy Adviser.