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Austrian Federal Office for Safety in Health Care
Austrian Medicines and Medical Devices Agency
Traisengasse 5
1200 Vienna
BASG
Clinical investigation application form for Medical Devices / In-vitro-Diagnostics to the national competent authority
 
Welcome to the CI/PS application form of BASGCreate a new application form for a Clinical Investigation according to Directive 93/42/EEC or Directive 90/385/EEC on Medical DevicesCreate a new application form for a Performance Study according to Directive 98/79/EC on In-vitro DiagnosticsUpload and Change an existing application form.Please note:
  • All relevant information needs to be entered directly into the form. No references to documents should be used.
  • This web-application is a stand-alone tool for creating the application form for the submission dossier. It is not an electronic submission to the BASG!
  • The timeout period for this web-application is 60 minutes. Please save your data at regular intervals by clicking "Save XML" to avoid data loss.
Further Information:Website of the Department for Clinical TrialsGuidance Document for Clinical Investigations with Medical Devices