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Regulation; European Union regulation: Title: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance)
The Medical Device Directive—Council Directive 93/42/EEC of 14 June 1993 concerning medical devices—is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the ...
European Standards (abbreviated EN, from the German name Europäische Norm ("European Norm")) [1] [2] are technical standards drafted and maintained by CEN (European Committee for Standardization), CENELEC (European Committee for Electrotechnical Standardization) and ETSI (European Telecommunications Standards Institute).
Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices (IVD), repealing Directive 98/79/EC (IVDD), which also concerned IVD. The regulation was published in April 2017 and is closely aligned to the EU regulation on medical devices.
European standards are generally annotated by the organization, standard number and year of publication (e.g. CEN 1789:2000 or CEN 1789/2007). Within member countries, [ 2 ] the annotation is likely to be adapted to include the local standards body, so that in Britain, the 'C' is dropped from the prefix, and replaced with ' BS ', in Germany ...
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964: ETS 50, [2] Protocol [3]).
ISO 14971 Medical devices — Application of risk management to medical devices is a voluntary consensus standard, [1] published by International Organization for Standardization (ISO) for the first time in 1998, and specifies terminology, principles, and a process for risk management of medical devices. [2]
The European Union of Medical Specialists (UEMS: Union Européenne des Médecins Spécialistes) is a professional organization of doctors representing medical specialists in the European Union, which was founded in 1958. It is the oldest medical organization in Europe, and represents about 1.6 million medical specialists. It promotes high ...