Compliance with ISO 13485 is often seen as the first step in meeting the European regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Devices according to EEC-Directives 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted. According to ISO 13485 the preferred method to prove conformity is certification of the Quality Management System by a Notified Body. The result of a positive assessment is the certificate of conformity allowing CE marking and the permission to sell the medical device in European Union.

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