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.

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:

Documents & Forms



Further inquiry note