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

Autori
Husić, Ivo ; Jelić, Miroslav ; Granić Husić, Milka ; Kovač, Ida

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, stručni

Izvornik
Third ISPO Central and Eastern European Conference / Jelić, Miroslav - Zagreb : Društvo za protetiku i ortotiku ISPO, 2002

Skup
Third ISPO Central and Eastern European Conference

Mjesto i datum
Dubrovnik, Hrvatska, 23.09.2002. - 25.09.2002

Vrsta sudjelovanja
Predavanje

Vrsta recenzije
Domaća recenzija

Ključne riječi
medical devices; fitting; law

Sažetak
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.

Izvorni jezik
Engleski

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