Notified bodies. Questions and answers.
Under the new system of regulation, many companies will need to develop working relationships with Notified Bodies to achieve approval to affix the CE mark to their products. This article answers some pertinent questions relating to Notified Bodies in general, and describes the situation in the United Kingdom.
Lindley
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Institute for Biomedical Equipment, Evaluation and Services (IBEES), Sheffield, UK.
D003365:Costs and Cost Analysis; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D007221:Industry; D008004:Licensure / Q000191:economics; D008422:Materials Testing; D011356:Product Labeling / Q000191:economics / Q000379:methods; D006113:United Kingdom