After lengthy negotiations with EU member states, the health committee in the European Parliament today backed new rules on medical devices, which range from contact lenses to implants, bone replacements, pacemakers and other health products.
Two new regulations strengthen safety in the process before and after a product is authorised to be sold in the EU.
S&D MEP Glenis Willmott, who drafted the European Parliament report on medical devices, said:
“The metal-on-metal hip scandal highlighted weaknesses in the current system. So we’ve introduced much stricter requirements for the bodies that authorise medical devices and will insist that particularly high-risk devices, such as implants, joint replacements or insulin pumps, will be subject to additional assessments by experts before they can be authorised.
“Aesthetic devices like cosmetic implants will also be covered by the new rules and we’ve introduced a Unique Device Identification system so we know which patient has which device. This will make it much easier to trace patients if there’s a problem and patients will also be given an implant card with the UDI, which they can use to access information via a publicly accessible database.”
S&D spokesperson on public health Matthias Groote MEP said:
“Our main goal is clear: reinforcing patient protection against defective products and preventing further scandals, such as the breast implant scandal in 2011 in France.
“Member states needed four years to find a common position on medical devices. Previously they blocked progress on the revision of the legislation – at the expense of patient safety. The revision of the legislation is long overdue. Patients can now be sure that there will be closer monitoring, certification procedures and improved traceability of medical devices.
“Thanks to the S&Ds, controls on so-called 'notified bodies', which are responsible for assessing the qualifications of staff and the performance and safety of medical devices, will be reinforced. In addition, there will also be a clear definition of the qualifications necessary for staff.”
Biljana Borzan MEP, the S&D spokesperson on in-vitro devices, said:
"A faulty diagnostic test can have fatal consequences for a patient if a disease is not detected or the wrong therapy is prescribed. We managed to put in place a system of expert pre-market scrutiny for new types of high-risk devices which is a big step forward for patient safety."
