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The EU strengthens testing on medical devices

The measures must be implemented by 2020.


Medical devices such as prosthesis and HIV screening tests will be subject to stricter testing in the European Union due to new European legislation, adopted after scandals such as those concerning the PIP breast implants.

On April 5, in a second reading, the European parliament approved two legislative projects on medical devices such as breast implants and hip prostheses, and on medical in vitro diagnostic devices, like pregnancy tests.

The new legislation, negotiated five years ago, plans for stricter testing from certification bodies which will be required to employ persons qualified in the medical field. It also plans for random inspections of manufacturers after the devices have been put on the market, and the implementation of an “implant card” for patients, in order to strengthen the possibility of tracing the products.

The measures concerning the medical devices must be implemented by 2020, those concerning diagnostic devices by 2022.

Source / Ouest France

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