[Medical devices. Regulatory framework and contribution of the German Federal Institute for Drugs and Medical Devices...

Medical devices are of great importance for the prevention, diagnosis and treatment of many diseases. With their broad range and interdisciplinarity, they represent both a very dynamic field of innovation and a significant sector of the economy. The European and thus the German Medical Devices Act aim in this context to make new medical devices for patients and users rapidly available while ensuring safety and performance at the same time. The main responsibility for this lies with the manufacturer. In addition, others are involved in a complex collaboration in the conformity assessment and also later in the marketing phase for the early identification, assessment and minimization of potential risks. This paper presents the legal framework for medical devices and the related roles and responsibilities of various stakeholders, especially the two federal agencies the German Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI). From the perspective of the BfArM the procedure and criteria for risk assessment of incident reports are explained and the experiences and wishes from regulatory practice are described. The active engagement of the BfArM to contribute knowledge from the incident report assessment within the relevant standards organisations and the medical profession is described using examples of medical devices from the field of out-of-hospital ventilation. The paper concludes with a look at future challenges, e.g. in combination products, IT networks and automatization, as well as on current developments to improve risk identification and assessment in a European context.