Verordnung des Bundesministers für soziale Sicherheit und Generationen über die grundlegenden Anforderungen an Medizinprodukte BGBl. II Nr. 9/2001, 05/01/2001, page 89

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. Manufacturers and distributors of medical devices must comply with these rules. The regulation aims to protect public health and ensure the safe use of medical equipment.