A Free Sale Certificate (FSC) may be required for the export of CE-marked medical devices and in vitro diagnostics outside the Union.

Please note:

• Free Sale Certificates are issued for medical devices and in vitro diagnostics only.
• A Free Sale Certificate can only be applied for by the manufacturer or the European authorized representative based in Austria.
• The medical devices and in vitro diagnostics applied for must meet the legal requirements and be CE-marked.
• Within the common market, CE-marked medical devices can be marketed without official confirmation. This means that no certificate of free sale is issued.
• Copies of already issued free sale certificates are not possible, a new application is required.
• Only directive products (RL 93/42/EEC, RL 98/79/EC, RL 90/385/EEC) OR regulation products (VO 2017/745, VO 2017/746) can be applied for with one application.

Application - Procedure

• Step 1: Read instructions
• Step 2: Fill in or update the overview list of documents
• Step 3: Create product list (products applied for) in the document overview list
• Step 4: Fill in application form
• Step 5: Send the application form, document overview list and documents to: fsc@basg.gv.at

Documents & Forms

• Instructions
• Documents-Overview Directive-Products
• Documents-Overview Prescription Products
• Documents-Overview general laboratory products
• Form: Application for certificate of free sale
• Form: Application confirmation general laboratory supplies

Links

• Fee regulation XIII
• Austrian Register for Medical Devices
• EUDAMED (registration as economic operator)