Verordnung der Bundesministerin für Gesundheit und Frauen über die grundlegenden Anforderungen an Medizinprodukte. BGBl. für Österreich Teil II n ° 90 vom 26/02/2004 (SG(2004)A/02450 du 04/03/2004 et SG(2004)A/02653 du 09/03/2004)

This regulation sets out the fundamental requirements for medical devices sold in Austria. It ensures that these products meet safety and performance standards before they can be placed on the market. This affects manufacturers, importers, and distributors of medical devices, as well as healthcare professionals and patients who use these products.