Clinical trials with medical devices
The electronic registration form is mandatory for a proper initial application for clinical testing of a medical device or performance assessment of an in vitro diagnostic medical device.
For ongoing studies based on old registration forms, a current application form in the new format must be submitted as part of the next application (e.g. amendment).
For clinical investigations with medical devices according to §40 Abs.2 MPG an application for approval has to be submitted to the BASG. Clinical investigatons and performance evaluation trials according to §40 Abs.3 MPG require confirmation of complete and valid submission by the BASG.
For detailed information on
- Submission of the clinical investigation
- Assessment and approval procedures
- Obligations during the clinical investigation and
- Obligations after completion of the clinical investigation
please refer to the document "Guidelines for the submission of clinical investigations according to MPG".
In addition, the general requirements for applications for clinical investigations with medicinal products of the European Commission (MEDDEV Guidelines) apply.
The application for approval of the clinical investigation must be submitted to all concerned Ethics Committees before the application is submitted to the BASG. Positive votes for all planned investigational sites need be submitted together with the application (the concept of a "Lead Ethics Committee" does not exist for medical devices/IVDs). Information on the Ethics Committees in Austria can be found at the Forum of the Austrian Ethics Commissions.
If a clinical investigation is to be amended after approval, a a mendment may be necessary. You can find out which changes are subject to approval by the authority or the Ethics Committee in the Guidelines for submission.
The current fees for clinical investigations can be found in the BASG fee tariff.