Originally Published MDDI
May 2004
Clinical Research
European Terms
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CE certification—approval from a notified body to offer a device for sale in the European Community.
CE mark—a symbol “CE” placed on the actual device and/or its labeling indicating that the device has received CE certification.
Competent authority—the government authority of a member state, usually the Ministry of Health.
Directive—similar to a law, passed by the European Commission.
Essential requirements—the elements of a directive with which a manufacturer must comply in order to
obtain CE certification. The essential requirements are harmonized throughout the European Community.
Notified body—a legal entity that is granted certain regulatory authorities by a competent authority.
Technical file—design history, technical specifications, and quality records of a medical device maintained by the manufacturer. Used for Class I, IIa, and IIb devices.
Transposition—adoption of a directive by a member state of the European Union.
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