Stakeholders in the medical device industry

Which authorities, organizations and associations you should definitely know,

  • if you want to enter the market with medical devices or in-vitro diagnostics?
  • if you want to become active as a distributor, importer or responsible person according to MDR / IVDR?

Here you will find all the links to the most important stakeholders in the medical device industry:

Federal Office for Safety in Health Care BASG: The Federal Office for Safety in Health Care (BASG) is entrusted with the execution of sovereign tasks in the area of control and authorization of medicinal products and medical devices and is a subordinate authority of the Federal Ministry of Health (BMG).

AUSTROMED represents the interests of medical device companies in Austria, representing the domestic medical device industry to the public and supporting its members.

Notified bodies: Notified Bodies of the European Union are state-appointed and state-supervised organizations, e.g. inspection bodies, which act on behalf of manufacturers to accompany and monitor the conformity assessment of manufacturers of medical devices.