Medical Devices Registry

Austrian Medical Devices Registry
Database for manufacturers (including manufacturers of custom-made devices) and importers of medical devices (including in-vitro diagnostics) and their authorised representatives as well as Notified Bodies, i.e., auditors and certifiers.

Under the Austrian Act on Medical Devices and also under European directives concerning medical devices and in-vitro diagnostics, Austria is obliged to maintain a registry of medical devices. Registration is obligatory for all persons and companies based in Austria that are responsible for circulating medical devices for the first time in the European Economic Area, as well as for auditors and certifiers of medical devices.

In order to handle registration procedures as quickly and efficiently as possible, the Medical Devices Registry has been organised as an Internet database with restricted access. The corresponding link extern website providing comprehensive further information on medical devices has been online as of 2 January 2002.

See below for downloading the information leaflet (in German) on the registry and notes on registration for orthopaedic shoemakers and technicians, opticians as well as dental technicians.

For any questions please contact the medical devices helpline (Mon to Thurs, 9:00 to 17:00 and Fri 9:00 to 12:00; phone no. +43 1 515 61-0, e-mail: medizinprodukte@goeg.at).

Information leaflet:
download Broschüre Medizinprodukte einfach – online – kostenlos registrieren (in German)
download Allgemeines Informationsblatt (in German) 
download Informationsblatt für Vertreiber/innen (in German) 

Registration leaflet: 
download Optiker/in (in German) 
download Orthopädieschuhmacher/in, Orthopädietechniker/in, Bandagist/in (in German)
download Zahnarzt/-ärztin (in German)
download Zahntechniker/in (in German) 
download Hörgeräteakustiker (in German) 

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