Safety Requirements for Medical Devices in Compliance with European Standards

Medical and laboratory devices are developed to support physicians and specialists in daily clinical routine or emergency situations. The safety aspect of medical devices is usually not perceived by the user, but it is just as important as the application aspect. This fact is taken into account by the Medical Device and In Vitro Diagnostic Regulations MDR 2017/745 and IVDR 2017/746, and European standards, which require the development of medical equipment according to the state of the art in the safety concept of the devices. For developers of medical and laboratory devices and instruments, it is a challenge to find a good compromise between the requirements of the applicable standardsStandards, the user requirements, and the increasing price pressure of the market. This chapter addresses basic questions from manufacturersManufacturers and developers, such as what level of safety must be implemented in devices to comply with the state of the art and how it can be achieved. It also provides a brief overview of the safety requirementsSafety requirements of the medical device regulations, with a focus on single fault conditions and the philosophy of integrated safety, together with an attempt to identify possible ways of proving conformity with these requirements. Selected examples from applicable product standards for medical electrical and laboratory equipment are used to provide a better understanding of how these requirements can be implemented in practice.