New in vitro diagnostic medical devices rules to improve patient safety

The new rules on in vitro diagnostic medical devices guarantees patients’ safety now and far into the future, says Margrete Auken.

Margrete Auken | Photo credit: European Parliament audiovisual

By Margrete Auken

04 Dec 2017

This spring, following nearly five years of negotiations, the new legislation on medical devices and in vitro diagnostic medical devices entered into force. As Parliament’s Greens/EFA group shadow rapporteur on in vitro diagnostic medical devices, I am proud of the improvements we have delivered for European patients.

The file covering HIV blood tests, pregnancy tests, blood sugar monitoring systems for diabetics and many more was highly technical.

Buried among long technical descriptions were highly sensitive ethical issues - as is so often the case when it comes to regulating biotechnology products and medicines. There was already legislation in place, but we made a number of changes to adapt the rules to existing and future technologies. Throughout this process, the focus for my group and me was patient safety.


Some of the key issues during the negotiations were similar to those for the medical devices regulation, namely: What should we require from the notified bodies that assess medical devices? How can we reinforce the requirements for clinical investigations and clinical data?

Consulting an expert panel for certain high-risk devices was extremely important. Additionally, traceability and liability provisions, in the event that a product fails, are crucial. Patients, hospitals and the health sector need to know who is at fault and be compensated where a device is defective. We also needed a central database so that we can follow devices.

Proper counselling and information for patients that want to use genetic testing for life-threatening diseases were crucial. It can be very dangerous if patients are left alone with medical results that may affect their lives. Lastly, we needed to update the classification system of in vitro medical devices so that devices are placed in the correct safety categories.

Overall, I was happy with the result. We have strengthened the rules on informed consent and the protection of vulnerable subjects. The notified bodies must operate under harmonised conditions throughout the EU.

Requirements on collection of data in clinical investigations on medical devices and performance studies on in vitro diagnostic medical devices have been considerably strengthened and they are aligned with those applicable for clinical trials on medicinal products for human use.

A designated reference laboratory checks the performance of devices against claims by manufacturers; there are consultations with an expert panel on evaluation for certain high-risk devices.

Liability is in place so that manufacturers and/or importers cover financially if their product is defective or becomes so during transportation. 

Moreover, we can trace devices so that we can be sure the hospital gets the authentic product. I am proud that we achieved greater transparency on the devices placed on the market through a central database so that patients, healthcare professionals and the public have comprehensive information on products available in the EU.

When it comes to the implementation, I would rather have seen a shorter transition period than the five years we had to agree upon. I also would have liked the Commission’s evaluation to come before 2027. Yet overall we have improved the safety of European patients today and far into the future.


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