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February 3, 2026
Approximately 5 minutes
Austrian BASG Role in Designating and Monitoring Notified Bodies for Medical Devices
Austrian BASG Role in Designating and Monitoring Notified Bodies for Medical Devices
1. Definition and Role of Notified Bodies
Notified Bodies are independent organizations that assess whether manufacturers and their medical devices meet legal requirements for safety and performance in conformity assessment procedures, particularly for higher-risk classes. Source: BASG Notified Bodies Page https://www.basg.gv.at/en/companies/medical-devices/notified-bodies
2. BASG as Competent Authority
The Federal Office for Safety in Health Care (BASG) is the Austrian authority responsible for designating and monitoring Notified Bodies under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). Source: BASG Notified Bodies Page https://www.basg.gv.at/en/companies/medical-devices/notified-bodies
3. Designation Process
The designation follows Chapter IV of MDR/IVDR:
- Application: Submit to BASG with evidence of compliance with Annex VII requirements and MDCG forms.
- Document review and on-site assessment with European Commission experts.
- Decision: Positive designations notified via NANDO database. Source: BASG Notified Bodies Page https://www.basg.gv.at/en/companies/medical-devices/notified-bodies
4. Ongoing Monitoring
BASG monitors designated bodies through:
- Annual audits of the body, subsidiaries, and subcontractors.
- Observation of conformity assessments.
- Review of technical documentation and evaluations.
- Full reassessment every 5 years with Commission experts. Source: BASG Notified Bodies Page https://www.basg.gv.at/en/companies/medical-devices/notified-bodies
5. List of Notified Bodies
The European NANDO database lists all designated Notified Bodies. No specific Austrian bodies are detailed on the BASG page. Source: BASG Notified Bodies Page https://www.basg.gv.at/en/companies/medical-devices/notified-bodies
6. Contact and Fees
Inquiries: medizinprodukte@basg.gv.at Fees per current BASG Fee Regulation. Source: BASG Notified Bodies Page https://www.basg.gv.at/en/companies/medical-devices/notified-bodies
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