title: [Medical Devices Law for pain therapists].
abstract: Medical Devices Law is a relatively new legal system, which has replaced the Medical Devices Regulations still well-known in Germany. German Medical Devices Law is based on European directives, which are, in turn, incorporated into national law by the Medical Devices Act. The Medical Devices Act is a framework law and covers a number of regulations that address specific topics within Medical Devices Law. In turn, in individual regulations, reference is made to guidelines, recommendations, etc. from other sources that provide detailed technical information on specific topics. Medical Devices Law is a very complex legal system, which needs to be permanently observed due to constant updating and adjustment. In the current article, the design and the structure of the system will be described, but special emphasis will be laid on important problem areas that need to be considered when applying and operating medical products, in this case by pain therapists in particular.
authors.affiliation: Klinik für Anästhesiologie und Intensivtherapie, Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Fetscherstraße 74, 01307, Dresden, Deutschland. Maic.Regner@uniklinikum-dresden.de.
authors.forename: M
authors.initials: M
authors.lastname: Regner
authors.affiliation: Klinik für Anästhesiologie und Intensivtherapie, Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Fetscherstraße 74, 01307, Dresden, Deutschland.
authors.forename: R
authors.initials: R
authors.lastname: Sabatowski
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence; D005858:Germany; D019983:Guideline Adherence / Q000331:legislation & jurisprudence; D006801:Humans; D062307:Medical Device Legislation / Q000458:organization & administration*; D009313:National Health Programs / Q000331:legislation & jurisprudence*; D059408:Pain Management / Q000295:instrumentation*; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence
keywords: Guidelines; Healthcare quality assurance; Medical devices; Pain; Recommendations