Federal Office for Safety in Health Care (BASG) - Austria

Overview of the BASG

The Federal Office for Safety in Health Care (BASG) is the competent authority in Austria responsible for the safety and quality of medicinal products and medical devices. It is operationally supported by the Austrian Agency for Health and Food Safety (AGES).

Key Roles and Responsibilities

1. Regulatory Oversight: BASG ensures that medical devices and medicines meet the legal requirements of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
2. Market Surveillance: The office monitors the Austrian market to ensure that only safe and compliant products are available. This includes inspections of manufacturers, importers, and distributors.
3. Vigilance and Reporting: Managing the national reporting system for adverse reactions and incidents. BASG evaluates these reports to take necessary safety measures (e.g., recalls).
4. Clinical Investigations: Authorizing and supervising clinical trials and investigations for medical devices to ensure subject safety and scientific validity.
5. Certification and Exports: Issuing Certificates of Free Sale and providing confirmations for the export of devices.
6. Inspection Services: Conducting audits for Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and Good Laboratory Practice (GLP).

Information for Economic Operators

Manufacturers and distributors must register in the European database EUDAMED. BASG provides guidance on registration and the use of national databases where EUDAMED modules are not yet mandatory.