The Regulation on Medical Devices 2017/745, active since 26 May 2021, compared to the directives that preceded it, has brought some innovations including, in the field of design and production of devices, greater attention than in the past, on clinical efficacy: it is now necessary to demonstrate that the device is not only safe but also effective and clinical evaluation is used to do so. In this context, the Laboratory provides its expertise for companies, hospitals and all health facilities that realize in their own medical device in order to verify compliance with the requirements.
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