CE MARK - Medical Devices

CE Mark, or CE marking as it is officially named, is an obligatory product mark for the European market, which indicates compliance 'certification' according to the requirements formulated in the approximately 22 European 'CE Marking Directives' and subsequent European standards.

Medical instruments, materials etc. intended to be used for human beings for certain defined purpose (e.g. diagnosis, prevention, treatment) and action not by pharmacological, immunological or metabolic means require to be CE Marked.

Therefore, the CE mark is mandatory for manufacturers and importers placing medical devices in the European market.

QA Management will assist organisations in obtaining CE-Marking for their own products. Some of the requirements are the compilation of technical files/ design dossiers , carrying out of risk assessments and achieving 13485: 2003 registration when applicable.

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