title: [The metrology of medical devices for the diagnostic in vitro: the European approach].
abstract: In the European Union, the measurement devices are regulated by the Directive 2004/22/EU establishing the mandatory requirements, rules of admittance and control/surveillance on the market. The medical laboratory analyzers don't come under the force of this Directive and are regulated by the Directive 98/72/EU in the same way as all medical devices for diagnostics in vitro. The new Russian Federal Law No102 "On the provision of the unification of measurements" came into force in 2009 is significantly harmonized with the similar international legislation and enable to eliminate the contradictions which for many years impeded the development of metrological support of clinical laboratory examinations.
authors.forename: V S
authors.initials: VS
authors.lastname: Antonov
mesh_terms: D019719:Diagnostic Equipment / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005062:European Union; D006801:Humans; D012015:Reference Standards