Medical devices

For around 10 years, the health economics experts at GÖG/ÖBIG have also been concerned with the medical devices used in Austria (i.e., approx. 500 000 products): every year, tens of thousands of artificial joints, almost 1 000 permanent pacemakers, and in rare cases artificial hearts, are implanted.

Apart from visual aids, walking aids or ECG devices, in recent years in-vitro diagnostics (IVD; medical laboratory diagnostics and laboratory instruments) have become increasingly important. They enable us at an earlier stage to obtain better and more reliable information relevant for diagnosis and monitoring of therapeutic interventions at an earlier stage. For instance, these devices include home pregnancy test kits but also specific blood tests for exclusive use in hospitals.

In addition to the core task of maintaining the Austrian Medical Devices Registry, our experts also contribute to the communication of specialised information on medical products in Austria (e.g., CE marking) and assist national authorities (the Federal Ministry of Health and the Austrian Federal Office for Safety in Health Care) with regard to market surveillance and consumer protection.

This includes the registration at GÖG/ÖBIG of:

• any IVD distributed by foreign enterprises in Austria;
• any quality certificates for medical devices that are issued by authorised Austrian institutions;
• any Notified Bodies.

In addition, GÖG’s medical devices helpline (medizinprodukte(at)goeg.at) has become a central contact point to which the Austrian business community may turn for cost-free information on registration in this field.

Another task is the representation of Austria at European level in the preparatory work for establishing an EU-wide medical devices registry. The final format of the EUDAMED database will be decided in September 2009. In this context, the expert in this area will also contribute to the enhancement and translation into German of the new Global Medical Devices Nomenclature (GMDN), which will be binding at international level.

A long-term goal is to expand the European PPI Pharma Price Information system to include price information on medical devices as well.

Contact: Claudia Habl