title: Incident reporting to BfArM - regulatory framework, results and challenges.
abstract: Medical devices are manifold and one of the most innovative fields of technology. As technologies advance, former limits cease to exist and complex devices become reality. Medical devices represent a very dynamic field with high economic relevance. The manufacturer of a medical device is obliged to minimize product-related risks as well as to demonstrate compliance with the so-called "essential requirements" regarding safety and performance before placing the device on the market. Any critical incident in relation to the application of a medical device has to be reported to the competent authority for risk assessment, which in Germany is either the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul Ehrlich Institute (PEI) depending on the type of device. In this article, the German regulatory framework for medical devices and the resulting tasks for BfArM are described as well as the topics of its recently installed research and development group on prospective risk identification and application safety for medical devices. Results of failure mode and root cause analyses of incident data are presented as well as further data on cases with the result "root-cause analysis not possible". Finally an outlook is given on future challenges regarding risk assessment for medical devices.
authors.forename: Robin
authors.initials: R
authors.lastname: Seidel
authors.forename: Ekkehard
authors.initials: E
authors.lastname: Stößlein
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Lauer
mesh_terms: D004869:Equipment Safety / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005858:Germany; D006077:Government Agencies / Q000458:organization & administration; D006801:Humans; D061214:Patient Safety / Q000331:legislation & jurisprudence; D011446:Prospective Studies; D018570:Risk Assessment; D012308:Risk Management