Innovation is happy to announce the compliance with Directive 93/42/EEC which provides us the ability to sell our medical device at the European Union market!
Directive 93/42/EEC of the European Union (EU) (also known as the Medical Devices Directive - MDD) details the Essential Requirements manufacturers and importers must meet to apply the CE mark and legally market or sell their devices in the EU. Because of the many types of devices covered by the MDD, the specific requirements depend on the classification and intended use of the device.
As part of the Notified Body assessment, Innovation developed technical documentation in order to provide a compliance of our device against the essential requirements and establish a quality management system that meets the requirements of the MDD. In this way, we state that our medical device complies with the regulations of legislation and the EU regulations regulating the field of medical devices and guarantee a safe and professional medical device. Conformity with the requirements of the EU regulations for medical devices and the legislation is proved by the granted EC Certificate.