German Ministry of Health
This article was originally published in The Gray Sheet
Executive Summary
Agency is planning to prohibit additional private marks "along side" the CE mark in an attempt to reinforce the value of the CE mark. The plan will prohibit supplemental marks or private marks if the private test marks refer only to the existing Essential Requirements of the European Directive. The ban would not create new legislation, according to Gert Schorn, Head of the Medical Devices/Standardization Department in the Federal Health Ministry, but merely implement European legislation and provide clairification
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