Borderline and Classification

Application Form for Qualification

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.

Key documents on Borderline and Classification