Clinical investigation application form

Austrian Federal Office for Safety in Health Care
Austrian Medicines and Medical Devices Agency
Traisengasse 5
1200 Vienna

Austrian Federal Office for Safety in Health Care

Austrian Medicines and Medical Devices Agency

Clinical investigation application form for Medical Devices / In-vitro-Diagnostics to the national competent authority

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Welcome to the CI/PS application form of BASGCreate a new application form for a Clinical Investigation according to Regulation 2017/745 on Medical DevicesCreate a new application form for a Performance Study according to Regulation (EU) 2017/746 on In-vitro DiagnosticsUpload and Change an existing application form.Since May 26th, 2021 no new applications for clinical investigations according to Directive 90/385/EEC and 93/42/EEC can be submitted.After May 26th, 2022 no new applications for performance studies according to Directive 98/79/EC can be submitted.For updating of an already created application form, please use "Update and change"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 Trials