Conformity evaluation in accordance with Medical Devices Directive 93/42/EC
Conformity with the requirements stated in the Directive 93/42/EC is mandatory for selling medical devices within the European Economic Area. Kimetec was reviewed whether these requirements were met. A CE mark on the medical devices indicates that our products passed the test. Depending on the risk class of the certified product, an institute named by the EU has to be charged. We co-operated with DEKRA Certification GmbH as competent service provider.