The European Union is comprised of 27 countries that require CE Marking. Three additional countries (Norway, Iceland, Liechtenstein), although not officially part of the European Union, are signatories to the European Economic Area (EEA). Switzerland is neither an EU member nor a signatory to the EEA, but they have transposed the Medical Devices Directives into their national law and these countries require CE Marking.
All medical equipment placed on the market in Europe must meet the requirements of either the Medical Devices Directive or the In Vitro Diagnostic Medical Devices Directive. Due to the importance placed on issues of safety within the medical world the requirements of the applicable Directive must be strictly applied by manufacturers wishing to place their products on the market in Europe.
OUTAO International Certification Center provides technical advice and support to clients whose products need to meet either of the Medical Devices Directives. Our services include.
Our CE Marking Services Include:
1) CE Marking Technical File or Design Dossier compilation and review.
2) Verification of Essential Requirements.
3) Product classification and identification of applicable standards for medical devices.
4) Implementation and maintenance of ISO 13485 quality systems.
5) Product labeling and packaging review.
6) Risk assessment and management (ISO 14971).
7) Development of Vigilance and Post Market Surveillance including Vigilance Standard Operating Procedures and Processes.
