About the Austrian Medical Devices Registry

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 (including in-vitro diagnostics) for the first time in the European Economic Area, as well as for auditors, certifiers, testing laboratories and inspection bodies of medical devices based in Austria. The registration of distributors based in Austria is voluntary but strongly recommended.

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 as of 2 January 2002 and was re-launched in May 2014.

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 information provided 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.

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 17:00, 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

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