According to the Austrian Act on Medical Devices (Medizinproduktegesetz), and according to European Directives concerning medical devices and in-vitro diagnostics (90/385/EEC, 93/42/EEC, 98/79/EC, amended by 2007/47/EC), Austria is obliged to maintain a registry of medical devices. The Austrian Public Health Institute (GÖG) was commissioned by the Ministry of Social Affairs, Health, Care and Consumer Protection (BMSGPK) to run and maintain the registry (since 2002). The scope of information to be entered into the Austrian Medical Devices Registry is regulated in the Austrian Ordinance on the notification of medical devices and in-vitro diagnostics (Medizinproduktemeldeverordnung).
In order to handle registration procedures as quickly and efficiently as possible, the Medical Devices Registry has been organized as an internet database with restricted access. The corresponding website www.medizinprodukteregister.at (in German only) providing comprehensive further information on medical devices has been online since 2 January 2002 and was re-launched in May 2014 and November 2020.
The cost-free online database for manufacturers (including manufacturers of custom-made devices), distributors and importers of medical devices (including in-vitro diagnostics) and their authorized representatives as well as Notified Bodies, and testing laboratories, inspection- and certification bodies is not publicly accessible. Registered users can only access their own information and cannot view data of other users.
In case a CE-marked product is already placed somewhere on the EU market and is already registered in the national registry of the corresponding country, it is not necessary to register the product again in the Austrian Medical Devices Registry.
National contact point for EUDAMED
GÖG also serves the national contact point for the European Databank on Medical Devices – EUDAMED, regarding data of manufacturers, authorized representatives and devices in Austria and data relating to certificates issued in Austria.
For any questions please contact the medical devices helpline:
Mon to Thurs 9:00 to 16:30, Fri 9:00 to 12:00
Stubenring 6
1010 Wien
Austria
Phone: +43 1 51 561-0
Fax: +43 1 513 84 72
E-Mail: medizinprodukte@goeg.at
Website: http://www.medizinprodukteregister.at