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The Measuring Instruments Directive 2014/32/EU, formerly 2004/22/EC, is a directive by the European Union, which seeks to harmonise many aspects of legal metrology across all member states of the EU. [1] Its most prominent tenet is that all kinds of meters which receive a MID approval may be used in all countries across the EU.
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 ...
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
The Joint Committee for Guides in Metrology (JCGM) is a committee which created and maintains two metrology guides: Guide to the expression of uncertainty in measurement (GUM) [55] and International vocabulary of metrology – basic and general concepts and associated terms (VIM). [34] The JCGM is a collaboration of eight partner organisations ...
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The term clinical engineering was first used in a 1969 paper by Landoll and Caceres. [2] Caceres, a cardiologist, is generally credited with coining the term.. The broader field of biomedical engineering also has a relatively recent history, with the first inter-society engineering meeting focused on engineering in medicine probably held in 1948.
Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.