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 standards, the user requirements, and
the increasing price pressure of the market.
This chapter addresses basic questions from manufacturers 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 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.