EC Directive 93/42/EEC (MDD)

The target of the EC Directive for medical devices 93/42/EEC of June 14, 1993 is to dismantle trade barriers within the Euriopean Community. In this connection it shall be guaranteed that the medical devices provide a high degree of protection for patients, users and third parties, and to achieve manufacturer's declarations about performance.

According to this the certification procedures, pursuant to EC medical devices Directive, are product-oriented with the objective that the products comply with the basic requirements in accordance with Annex I of the Directive. Beyond the standard DIN EN ISO 13485:2003 1) the particularly specified QM requirements mentioned in the Directive are taken into account during the assessment of quality management systems according to EC Directive. The system executed in this manner is marked by the EC Directive as quality assurance system (QA system).

1) DIN EN ISO 13485:2003: quality management system for medical devices; requirements for regulatory purposes