[Medical Devices Law for anesthesiologists].
The Medical Devices Law is a relatively new legal system, which has replaced the still well-known medical devices regulations in Germany. The Medical Devices Law in Germany is based on European directives, which have been translated into national law with the Medical Devices Act. The Medical Devices Act is a framework of regulations and incorporates a number of decrees that address specific topics within the medical devices directives and in turn individual regulations refer to guidelines and recommendations from other sources which provide detailed technical information on specific topics. Overall, the Medical Devices Act represents a very complex legal system, which needs to be permanently observed with respect to continuous updating and adjustment. In this article the design and the structure are described but most of all the article filters significant problem areas that need to be considered when using and operating medical devices, especially for anesthesiologists.
Klinik für Anästhesiologie und Intensivtherapie, Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Fetscherstraße 74, 01307, Dresden, Deutschland. Maic.Regner@uniklinikum-dresden.de.
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D000776:Anesthesiology / Q000331:legislation & jurisprudence*; D004864:Equipment and Supplies / Q000592:standards*; D005858:Germany; D006801:Humans; D007883:Legislation, Medical; D010820:Physicians; D011358:Product Surveillance, Postmarketing
Anesthesiologists; Guidelines; Medical Devices Act; Problem areas; Recommendations