Stricter monitoring and certification procedures to ensure full compliance and traceability of medical devices such as breast or hip implants have been agreed by the European Parliament.
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 .
Parliament’s amendments would reinforce public access to clinical data for both patients and health professionals, so that they have better knowledge about 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.
MEPs will now start negotiating the final rules with member states.
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