engleski

Volountary involving of CE norms in fitting of orthopaedic devices in Croatia

The European Union introduced the law (Directive 93/ 42/ EEC), which was accepted in 1993 and came into force on the 14th of June 1998 for the areas of the European Community. This law regulates the production, application and safety of all medical devices except implants and in vitro diagnostics. Medical devices were classified in four categories, and that classification is also valid for custom (individually) made devices. Fully aware that we would not be able to avoid these regulations, and, at the same time, aware that this kind of regulation increases the quality level of production and application, Otto Bock Adria sent contacted the HZZO and the Ministry of Health with the initiative to include the CE Norms in the Republic of Croatia. As the changes are slow, Otto Bock Adria voluntarily incorporated, from 1st of January 2002, the regulations and documentation in accordance with the already mentioned regulations. In this report, the experience and organisational changes needed for the proper functioning of this system will be presented and also some proposals will be offered regarding the expansion of these regulations to other interested companies.

medical devices; fitting; law

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