Need Regulatory Help? Try Our Platform
Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.
February 2, 2026
Approximately 5 minutes
Obligations for Medical Device Manufacturers in Austria
Obligations for Medical Device Manufacturers in Austria
1. Definition of Manufacturer
A manufacturer is a natural or legal person who manufactures or fully refurbishes a device, or has a device designed, manufactured or refurbished, and markets it under their name or trademark, as defined in Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). Source: BASG Manufacturer Page https://www.basg.gv.at/en/medical-devices/manufacturer
2. Borderline and Classification
Manufacturers are responsible for correct qualification and classification of products as medical devices. BASG provides delimitation or classification decisions upon application by Austrian-based manufacturers or authorized representatives. Applications use form F_I235, with fees per current regulation. Source: BASG Manufacturer Page https://www.basg.gv.at/en/medical-devices/manufacturer
3. Registration and Fees
Registration details are handled via the Austrian Register for Medical Devices. Annual medical device fee declarations are required by June 30 for the previous year. Source: BASG Manufacturer Page https://www.basg.gv.at/en/medical-devices/manufacturer
4. Export Certificates
Manufacturers or authorized representatives in Austria can request Certificates of Free Sale (CFS) for CE-marked devices exported outside the EU, or confirmations for non-medical products that might be perceived as medical devices. Source: BASG Manufacturer Page https://www.basg.gv.at/en/medical-devices/manufacturer
5. Vigilance Reporting
Manufacturers must report serious incidents and field safety corrective actions (FSCA) to BASG via email, using European forms. FSCA requires German field safety notices and customer lists. Source: BASG Manufacturer Page https://www.basg.gv.at/en/medical-devices/manufacturer
6. Market Surveillance and Inspections
BASG conducts inspections (announced or unannounced) covering safety, quality, and compliance. Manufacturers must cooperate fully, providing access and documentation. Source: BASG Manufacturer Page https://www.basg.gv.at/en/medical-devices/manufacturer
7. Derogations and Supply Interruptions
Derogations allow placement of non-CE marked devices in public health interests upon application. Manufacturers must notify of supply interruptions likely to cause harm, at least six months in advance. Source: BASG Manufacturer Page https://www.basg.gv.at/en/medical-devices/manufacturer
8. Contact
For inquiries: medizinprodukte@basg.gv.at Source: BASG Manufacturer Page https://www.basg.gv.at/en/medical-devices/manufacturer
Ask Anything
We'll follow up with you personally.
Related Articles
Approximately 5 minutes
Austrian BASG Consumer Guide to Medical Devices
The Austrian BASG provides consumers with essential information on medical devices, including definitions, CE marking requirements, vigilance system, incident reporting procedures, and answers to common questions about safety and responsibilities.
Approximately 5 minutes
BASG Guidance on National Scientific Advice (NASA) for Applicants in Austria
The BASG guidance document details the operational procedure for requesting National Scientific Advice (NASA) on medicinal product development, covering application process, timelines, fees, and consultation formats.
Approximately 5 minutes
Obligations for Medical Device Importers and Distributors in Austria
In Austria, importers and distributors of medical devices must register, pay annual fees, report vigilance incidents to BASG, cooperate with inspections, and comply with MDR/IVDR obligations including forwarding complaints and informing about risks.
Approximately 5 minutes
Annual Medical Devices Fee in Austria
In Austria, any person supplying medical devices to end users must annually declare and pay a lump-sum fee based on the highest device class dispensed and net turnover thresholds, with exemptions for low sales, pharmacies, and small companies.