New medical device regulations: the regulator’s view

[摘要] Advances in medical device technology have been dramatic in recent years, resulting in both an increased number of medical devices (estimated to be approximately 500000 different devices in Europe) and an increase in the invasiveness and critical function which devices perform. Almost everyone will be exposed to a medical device in their lifetime and many more people are being implanted with permanent devices which often cannot be subsequently removed – patients therefore rely on medical devices being safe and performing as intended for their lifetime. The aims of EU policies with respect to public health include measures to set high standards of quality and safety for medical devices, in addition to a range of other areas of co-operation.1 In this context, two new regulations entered into force in Europe in May 2017, the Medical Device Regulation (MDR)2 and the In Vitro Diagnostic Device Regulation (IVDR).3 These regulations will replace the current directives in a phased manner with a three-year transitional period for the MDR and a five-year transition for the IVDR (Fig. 1).

[学科分类] 神经科学

[关键词] EU regulations;medical device;registry