Clinical trials with medical devices
New validation process in preparation for Regulation (EU) 2017/745 New
In preparation for Regulation (EU) No. 2017/745, which will become applicable on 26.05.2021, the following rules for validation will apply to clinical investigations of medical devices as well as performance studies of in-vitro diagnostics (for a harmonised processing procedure) from 1 April 2021:
The following situations will block the processing of an initial application and will result in an immediate e-mail response to the applicant that the procedure cannot be further processed:
- Missing or corrupted BASG application form (PDF and XML).
- No final positive ethics vote available for the overall study.
- clinical investigation plan, investigator’s brochure or patient information(s) are missing or do not comply with the versions in the final ethics committee opinion
A final positive ethics vote means that the Ethics Committee's evaluation of the dossier was completed and no further changes are requested. A preliminary ethics vote ("vorläufiges Ethikvotum") or a processing notice ("Bearbeitungsmitteling") does not count as a final ethics vote
If at least these documents are available, a confirmation of receipt will be sent from the BASG system PHAROS to the applicant. Confirmations of receipt from the e-mail system do not apply here. From this date the BASG undertakes to confirm that the notification is valid or to send a deficiency letter within 14 days .
The applicant is then also granted a period of 14 days for correction or submission of documents. The deficiency letter will be sent as a formal hearing to the e-mail address provided by the applicant in the application form. Receipt should be confirmed. It is therefore essential that this contact information is correct and maintained.
Upon receipt of the requested or corrected documents, BASG will complete the validation within one week.
For clinical investigations/performance studies according to § 40 (3) MPG the valid submission will then be confirmed (at the latest) and the study can be initiated. For clinical investigations according to § 40 (2) MPG, the 60-day period for the scientific and regulatory review begins thereafter.
If no response is received within 14 days or if the application cannot be completed, the application will be rejected.
Electronic submission via e-mail
Due to current events, all attachments should be submitted exclusively by e-mail to clinicaltrialsbasg.gvat. For details we refer to the BASG submission guidance.
Electronic Submission Form of the BASG
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).
General information
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.
Sonstige BASG Formulare
- Application form for significant changes during the clinical investigation/performance evaluation.30/03/2016
- Form: SAE Line Listing| 27 KBEuropean form for reporting and updating of all SAEs during a clinical investigation/performance evaluation.12/10/2015
- National reporting form for SAEs in clinical investigations and performance evaluations15/04/2020
- Form for notifcation of the planned or premature end of the clinical investigation/performance evaluation
(German and English)30/03/2016
