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.

Current laws and ordinances in force, as available in German from the Austrian Legal Information System (RIS)

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

New legislation on falsified medicines 2011/62/EU

*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

• Harmonised Standards - MDR
• Harmonised Standards - IVDR

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)

• Directive on CJD of the Federal Ministry of Health *
   

Fees for medical devices

• Medical Device Levy Ordinance *

• Austrian Blood Safety Act 1999
• Austrian Tissue Safety Act 2008
• Ordinance on human tissue banks 2008
• Ordinance on human tissue procurement establishments 2008
• Ordinance on tissue vigilance 2008