Legal basis
Legal basis for the Austrian Federal Office for Safety in Health Care (BASG)
Federal law establishing the Austrian Agency for Health and Food Safety and setting up the Federal Office for Food Safety and the Federal Office for Safety in Health Care (Gesundheits- und Ernährungssicherheitsgesetz - GESG)
Gesundheits- und Ernährungssicherheitsgesetz GESG 2002
To make sure that you are on the latest valid status, please visit the Austrian Legal Information System RIS.
Laws and regulations
Current laws and ordinances in force, as available in German from the Austrian Legal Information System (RIS)
Eudralex
The body of European Union legislation in the pharmaceutical sector is compiled in Volume 1 and Volume 5 of the publication "The rules governing medicinal products in the European Union" - Eudralex
Medical devices
*only available in German
Austrian legal basis
- Medical Devices Act (MPG 2021) *
- Medical Device Operator regulation (MPBV) - legacy devices & old devices *
- Electronic submission regulation *
- Medical Device Notification regulation *
European legal basis
- Regulation (EU) 2017/745 on medical devices (MDR)
- Regulation (EU) 2017/746 on in vitro diagnostics medical devices (IVDR)
- Regulation (EU) 2023/607 amending the transitional provisions
- Directive 93/42/EEC concerning medical devices - legacy devices & old devices
- Directive 98/79/EC on in vitro diagnostic medical devices - legacy devices & old devices
- Directive 90/385/EEC on active implantable medical devices - legacy devices & old devices
Guidances
- MDCG Guidance Documents
- Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending the transitional provisions
Further relevant regulations and directives
- Regulation on Magnetic Field Therapy Devices (MFTGV) *
- Regulation on the supply of HIV tests for self-testing *
- Regulation on Implant Registry *
- Free medical device regulation *
- Regulation (EU) No 722/2012 concerning Requirements with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin
- Regulation laying down accompanying measures to Regulation (EU) No 722/2012 (MPTG-VO)
Fees for medical devices