Free Sale Certificate - (FSC)
A Free Sale Certificate (FSC) may be required for the export of CE-marked medical devices and in vitro diagnostics outside the Union.
- 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: email@example.com
Documents & Forms
- 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