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EU backs stricter safety rules to ensure medical devices are traceable

EU backs stricter safety rules to ensure medical devices are traceable

The European Parliament has adopted two new regulations imposing stricter rules on medical devices’ safety. This comes in the wake of scandals involving the toxic metal-on-metal hip implants and the PIP breast implants, which saw thousands of patients affected.

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“This is good news for patients,” said Brian Hayes MEP. “These new rules will ensure that medical devices comply with EU patient safety. Problems have occurred in other areas too, with stents that are implanted into the brain or unreliable HIV tests. The new regulations puts an end to fraudulent and shady producers and also strengthens respectable producers”, he added.

Medical devices can include anything from plasters to contact lenses, pregnancy tests, dental filling materials, X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.

“High risk devices, such as implants, joint replacements or insulin pumps will be subject to additional expert assessments before they can be authorised.

The rules also provide for:

  • Random inspections of producers’ facilities after devices have been placed on the market,
  • An additional safety checking procedure for high risk devices, such as implants or HIV tests.
  • An “implant card” for patients, enabling patients and doctors to track which product has been implanted
  • Clinical evidence of medical device safety to be provided by manufacturers (as for medicines), especially in the case of higher risk classes.

“My colleague Mairead McGuinness MEP has been working hard in this area and deserves credit. These new Regulations pave the way to a more patient-friendly environment, where transparency and patients’ information and choice are a priority and where patients can benefit from innovative, highly performing devices and new therapies.”

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