Applications for Qualification and Classification

Applications for qualification and classification

Manufacturers or authorised representatives who are legally established in Austria may submit applications for qualification and classification of devices regarding the relevant directives (93/42/EEC, 90/385/EEC, 98/79/EC) according to § 5a of the Austrian Medical Devices Act (Medizinproduktegesetz - MPG) BGBl. Nr. 657/1996, revised by BGBl. I Nr. 32/2014. Manufacturers or authorised representatives located in other countries are encouraged to contact their respective National Competent Authorities.


Applicable fees can be found here: Regulation on fees

Application form

    EU Hilfestellung bei der Abgrenzung

    Die Europäische Kommission stellt eine eigene Internet-Seite mit Guidance (nicht rechtsverbindlich) für die Abgrenzung und Klassifizierung von Medizinprodukten bereit, die auch Hilfestellung bei der Abgrenzung zu Arzneimitteln, Bioziden und Kosmetika gibt.

    Key documents on Borderline and Classification 

    Created: 10.11.2014 | Page last modified: 16.06.2017

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