Borderline and Classification
General information
The Federal Office for Safety in Health Care carries out qualifications of medical devices based on § 5a of the Austrian Medical Devices Act. We would like to point out that a fee-based application for qualification can only be made by a manufacturer or authorised representative legally established in Austria. The current fee tariff must be considered. The European Commission provides further information on the qualification and classification of medical devices.
Further inquiry note
Page last modified:
04/11/2019