Medical devices

Besides expertise in medicines and pharmaceutical policies, the Pharmacoeconomics Department has also been for long involved in the activities related to medical devices.

Regulatory activities

Medical devices include a variety of medical technologies and procedures such as syringes, pacemakers, wheelchairs. In order to improve market surveillance in this area, the Medical Devices Act regulates that Austria has to keep its own register for medical devices as well as a register for testing, monitoring and certification bodies.

Austrian Register of Medical Devices

Gesundheit Österreich GmbH was commissioned in 2001 by the then Austrian Federal Ministry of Health to set up and maintain these registers. Since January 2002, the registration of medical devices and in-vitro diagnostics has only been possible on the website and carried out by all companies or persons subject to registration in the form of a free self-registration.

For further information: see Austrian Register of Medical Devices (in German)

European Database for Medical Devices (EUDAMED)

GÖG, together with the Austrian Federal Ministry of Labour, Social Affairs, Health and Consumer Protection, acts as the national contact point for the European Database for Medical Devices (EUDAMED) and has been transmitting the Austrian data to the European database since May 2011. This allows a quick exchange of information between EU Member States, and it will be able to respond quickly to the safety risks of medical devices.

Policy work

More recently, the Pharmacoeconomics Department has been working on policy-related aspects of medical devices, in particular prices and policies for pricing and reimbursement of medical devices.

A sub-group of the PPRI network on medical devices was established in 2018.