Recital (15)

Having regard to the impact that shortages of certain medical devices and in vitro diagnostic medical devices can have on patient safety and public health, a prior notice mechanism should be introduced to enable competent authorities and health institutions, in particular, to take mitigating measures where necessary to ensure patient health and safety. Therefore, where manufacturers anticipate, for any reason, the interruption or discontinuation of supply of medical devices or in vitro diagnostic medical devices and it is reasonably foreseeable that such interruption or discontinuation can result in serious harm or a risk of serious harm to patients or public health in one or more Member States, the manufacturer should inform the relevant competent authorities as well as the economic operators to whom they directly supply such devices and, where applicable, the health institutions or healthcare professionals to whom they directly supply such devices, thereof. The risk of serious harm to patients or public health can, for example, be due to the relevance of such devices for ensuring essential healthcare services in one or more Member States, the dependency of patient health and safety on the continuous availability of such devices in one or more Member States, or the absence of suitable alternatives, also in light of the expected length of the interruption, the quantities of devices already made available on the market and available stocks or timelines for procuring alternatives for such devices. The information should be provided by the manufacturer and other economic operators in the downstream supply chain until it reaches the relevant health institutions or healthcare professionals. As the risk of shortages of such devices is particularly relevant during the transition from Directives 90/385/EEC, 93/42/EEC and 98/79/EC to Regulations (EU) 2017/745 and (EU) 2017/746, the prior notice mechanism should also apply to devices placed on the market in accordance with the transitional provisions laid down in Regulations (EU) 2017/745 and (EU) 2017/746.