Testing for technical files: avoiding too little and too much.
Since 13 June 1998, it has been mandatory for all new and existing medical devices to be CE-marked according to the Medical Device Directive. However, for certain electromedical devices full compliance with the requirements of EN 60601-1 as a means of obtaining the CE mark may not be necessary. This article looks at some of these products and explains how they may still qualify for distribution in the European medical market.
Clifford
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SGS Medical Devices, Sheffield, UK. Andrew_Clifford@sgsgroup.com
D004558:Electric Stimulation / Q000295:instrumentation; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D019983:Guideline Adherence; D006801:Humans; D011356:Product Labeling / Q000331:legislation & jurisprudence* / Q000592:standards; D018570:Risk Assessment