Medical devices: better controls and traceability to ensure patients’ safety 

Press Releases 
Plenary session 

Stricter monitoring and certification procedures to ensure full compliance and traceability of medical devices such as breast or hip implants were agreed by Parliament on Wednesday. MEPs also tightened up information and ethical requirements for diagnostic medical devices used for example in pregnancy or DNA testing.

The proposed legislation seeks to increase patient safety and to strengthen traceability from producer to patient, without creating additional burdens for innovative small manufacturers.

"We talk about products that are supposed to help patients in their suffering, in their illness. We should assist doctors in making sure they are using the best and safest products to help their patients (...) Doctors have been telling us that hundreds of hip replacements are defective and have to be removed with huge expense for health systems and suffering for patients. We need a much better system", said rapporteur Dagmar Roth-Behrendt (S&D, DE). Her report was approved by 541 votes to 19, with 63 abstentions.

Lessons learnt from the breast and hip implants scandal

Parliament’s amendments would strengthen the procedure for placing new medical devices on the market so as to ensure that unsafe products or devices that have undergone insufficient controlled trials on patients can no longer be used on or in them..

In future, MEPs say, notified bodies should have a permanent team of in-house experts who meet up-to-date qualification requirements. A new group of bodies should assess devices considered “high risk”, for instance, devices that can be implanted in the human body.

In the wake of recent scandals, patients wearing implants would also receive an "implant card" and be registered, so that they can be alerted if any incidents are reported with a similar product.

Safety rules for in-vitro diagnostic medical devices

In separate legislation, MEPs reinforced patient safety for medical diagnostic devices used, for example, to perform pregnancy tests, diabetes self-tests, and HIV and DNA tests. Parliament called for an ethics committee to be set up and introduced provisions to require the informed consent of patients to testing protocols and genetic counselling.

"Yes indeed, there are problems in the world of medical devices and this also applies to diagnostic devices. An HIV test that has been on the market for years has been giving ‘false negative’ results, with all the consequences arising from that in cases of blood transfusion or other kinds of contact", said Peter Liese (EPP, DE), who is steering the legislation through Parliament. His report was approved by 492 votes to 21, with 117 abstentions.

Next steps

The European Parliament voted on its first reading of the draft legislation, in order to consolidate the work done so far and hand it over to the next Parliament. This ensures that the MEPs newly elected in May can build on work done during the current term.

Procedure: Co-decision (Ordinary legislative procedure), first reading