for the medical device
CE 0197 is a certification of medical quality used by the European community, analogous to FDA certification in the United States.
The CE Mark, which is affixed to a product or its packaging, is considered proof that a product has met the requirements of the harmonized European standard, or directive. “CE” refers to Communauté Européen. Translated from the French, this literally means European Community. The European Commission, which administers the program, describes the CE Mark as a “passport” for goods to be sold freely within the internal European market. It is required by law if the product falls under one of the New Approach Directives. It is not a quality mark, nor is it a mark for consumers. Intended for Member State authorities, it is the visible sign to those authorities that your product is in compliance with the New Approach Directives. All manufacturers are required to affix the CE mark to products that are governed by New Approach Directives. CE marking on a product indicates to all authorities that the product is in compliance with the essential health and safety requirements of all directives that apply to the product.