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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 Tuesday. MEPs also tightened up information and ethical requirements for diagnostic medical devices used for example in pregnancy or DNA testing. They will now start negotiating the final rules with member states.

The proposed legislation seeks to improve transparency of information for patients and medical staff and to strengthen traceability rules, without creating additional burdens for innovative small manufacturers.

"We talk about products which are supposed to help patients in their suffering, in their illness. We should assist doctors in making sure they are using the best possible products when they want to assist their patients. To date, doctors have been telling us that hundreds of hip replacements are defective and have to be taken out again, with huge expenses for the health systems and suffering for patients. We need a better system," said rapporteur Dagmar Roth-Behrendt (S&D, DE).

Lessons learnt from the PIP breast implant scandal

Parliament’s amendments would reinforce public access to clinical data for both patients and health professionals, so that they know better which product to use. In the wake of recent scandals, where the number of patients with potentially defective implants remained unknown, MEPs want patients to receive an "implant card" and to be registered, so that they can be alerted if any incidents are reported with a similar product.
 
Only experts can deliver the "CE" mark

Bodies in charge of assessing medical devices often rely on subcontractors. In future, MEPs say, they 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 inside the human body.

Clearer responsibilities for reprocessing "single use" devices

While some medical devices are commonly reused (e.g. stethoscopes) and others not (syringes for instance), many devices labelled as “single use” only are currently being reused on other patients after being disinfected (e.g. certain catheters or forceps). MEPs say that persons or institutions who wish to reprocess a single-use device must be held liable and ensure the traceability of the reprocessed device. A list of devices unsuitable for reprocessing should be set up via delegated acts.

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 for the informed consent of patients and genetic counselling.

"Yes indeed, there are problems in the world of medical devices and this also applies to diagnostic devices. There has been an HIV test on the market for years that has been giving false negative results, with all the consequence arising from that in cases of blood transfusions or various other kinds of contact," said MEP Peter Liese (EPP, DE), who is steering the legislation through Parliament.

Next steps

The plenary voted to open negotiations with Council on both the files in the coming weeks, Possible first-reading agreements would then be put to a vote in the Public Health committee before seeking final approval by the full House.

Procedure: Co-decision (Ordinary Legislative Procedure), 1st reading