EU Pushes to Tighten Medtech Regulations

By Jill | Uncategorized, , , , , , ,

In 2011, it was revealed that the French firm Poly Implant Prothèses (PIP) had been using cheap, industrial silicone, not intended for medical purposes, in breast implants for a decade. As the world’s third largest global supplier of breast implants, the scandal affected 100,000 women in Europe and 400,000 women globally. The scandal moved the European Union to update existing legislation over medical devices.

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In Europe, as in the United States, the term medical technology covers an estimated 1.5 million different types of medical devices used worldwide. All are used for disease prevention and diagnosis, treatment, and rehabilitation from illness. In Europe, common medical devices such as eyeglasses and blood pressure cuffs, are categorized as Class I, a low-risk category. Complex technology used inside the body, such heart valves, artificial hips, and breast implants are called Class III devices.

In Europe patients and healthcare providers do not always have access to information on how medical products are tested and what clinical evidence shows they are safe and effective. It can also be difficult to trace medical devices back to their supplier. After the PIP scandal, the executive body of the European Union, the European Commission, proposed a way to improve medtech evaluation and enhance ways to trace products.

Methods for efficiently achieving the commission’s goals were a source of controversy. Some support establishing a central Committee for the Authorization of Medical Devices for premarket approval of Class III devices. Those within the medtech industry believed this approach would be cumbersome and cause delays in bringing safe, life-giving medical devices to the public. In addition, the proposed committee would have done little to address criminal fraud like the PIP scandal.

In September 2013, the European Commission adopted two measures to improve the safety of medical devices. The measures clarified criteria to be met by the 80 independent organizations designated to oversee manufacturing of Class III medical devices. The tasks include random, unannounced medtech factory audits and quality control checks of raw materials such as those used in the PIP case. This measure was seen as a compromise that balanced the needs of the public against those of the medtech industry.

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