Directive 2007 47 ec of the european parliament and of the council of 5 september 2007 amending council directive 90385eec on the approximation of the laws of the member states relating to active implantable medical devices, council directive 9342eec concerning medical devices and directive 988 ec concerning the placing of biocidal products on the market text with eea relevance. Directorate b, unit b2 cosmetics and medical devices medical devices. Gartner, a reihe medizinproduktesicherheit, tuv media gmbh, 2008 2011. Medical products council directive 9342eec at detax. With the first release of help and manual in 1997 the company changed its business focus to documentation software and developer tools. Directive 2001104 ec of the european parliament and of the council of 7 december 2001 amending council directive 9342eec concerning medical devices. Directive 2007 47 ec of the european parliament and of the council of 5 september 2007. Evcecc installation electronic vessel control d4, d6 components and cables controls single engine control aluminum, stainless steel twin engine control aluminum, stainless steel side mounted controls. Wir zeigen was ihr produkt, ihre maschine, anlage oder software alles kann. The company was founded in 2000 and has been active in the european and asian.
Ec software was originally founded in 1993 and went a long way from the initial small oneman shop for pointofsale software to the documentation tools specialist that it is today. Software for general purposes when used in a healthcare setting is not a medical device. Optogait is a medical device md number 467316r of italian ministry of health md directory compliant to 9342eec directive with the subsequent 2007 47 ec. We herewith declare that the above mentioned products are in conformity with the council directive 9342eec for medical devices including the mdd amendment 2007 47 ec. All supporting documentations are retained under the premises of the manufacturer. Advocate general endorses meddev guidance on classification of software programmes as medical devices. Directive 2007 47 ec of the european parliament and of the council of 5 september 2007 amending council directive 90385eec on the approximation of the laws of the member states relating to. Medical device software software life cycle processes. Richtlinie 9342ewg uber medizinprodukte mdd 1993, zuletzt geandert durch 200747eg. Particular care should be taken to ensure that the. The values of fuel consumptions, co2 emissions and energy consumptions shown are determined according to the european regulation ec 715 2007 in the.
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