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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) Made by: Council: Made under: TFEU/art 294 par 6: Journal reference
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 ...
CEN 1789:2020 is the European Union standard for ambulances and medical transportation vehicles. This European standard specifies requirements for the design, testing, performance and equipping of road ambulances used for the transport and care of patients.
European Committee on Antimicrobial Susceptibility Testing (EUCAST) is a scientific committee for defining guidelines to interpret antimicrobial resistance. [1] It was formed in 1997 and is jointly organized by ESCMID , ECDC and other European laboratories.
The European Pharmacopoeia: setting quality standards for Europe and beyond and supplying pharmaceutical reference standards [ edit ] Published and regularly updated by the EDQM/ Council of Europe in English and French, the two official languages of the Council of Europe, the Ph. Eur. is a compendium of official quality standards for medicines ...
The quality standards of the European Pharmacopoeia apply throughout the entire life-cycle of a product, and become legally binding and mandatory on the same date in all thirty-nine (39) signatory states, which include all European Union member states. Several legal texts make the European Pharmacopoeia mandatory in Europe. [1]
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, [1] [2] sometimes called Euronorm (abbreviated EN, from the German name Europäische Norm, "European Norm"), [3] [4] are technical standards which have been ratified by one of the three European Standards Organizations (ESO): European Committee for Standardization (CEN), European Committee for Electrotechnical Standardization (CENELEC), or European Telecommunications ...