Free Sale Certificate - (FSC)
A certificate of free sale may be required for the export of CE marked medical devices and in vitro diagnostics outside the common market.
- Certificates of free sale (FSC) are only issued for medical devices and in vitro diagnostics.
- A certificate of free sale can only be applied for by the manufacturer or the European authorised representative based in Austria.
- The medical devices and in vitro diagnostic medical devices applied for must fulfil the legal requirements and be CE-marked.
- Within the common market, CE-marked medical devices can be marketed without official confirmation. I.e. no certificate of free sale is issued.
- Copies of already issued certificates of free sale are not available, a new application is necessary.
- 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 the application form
- Step 5: Send the application form, the overview list of documents and the documents to: email@example.com
Documents & Forms
- Documents-Overview Directive-Products
- Documents-Overview Prescription Products
- Form: Application for Certificate of Free Sale
- Form: Application confirmation general laboratory supplies