Clinical investigations with medical devices

Electronic submission via e-mail

Due to current events, all attachments should be submitted exclusively by e-mail to clinicaltrials@basg.gv.at. For details we refer to the BASG submission guidance.

New fee tariff since 1 August 2021!

As of 01.08.2021, a new fee regulation of the BASG was put into force. For clinical investigations of medical devices according to Regulation (EU) 2017/745, which are submitted from this date, new fees apply.

The tariffs for academic clinical investigations of medical devices according to Regulation (EU) 2017/745 are thus no longer reduced! The same fees for initial and amendment applications (tariff points XII.2.a-g) apply as for commercial studies.

The fee reduction still applies to performance evaluation reviews and amendment requests for studies according to the Medical Devices Act, BGBl. I No. 46/2021 (tariff point XII.1.a-b).

Please refer to the BASG fee schedule for the current fees.

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.

From 26.05.2021, new studies for medical devices can only be applied for according to Regulation (EU) 2017/745. The new BASG application form will be available from 26.05.2021, 06:00. Application forms for already notified or ongoing clinical investigations can of course continue to be updated.

Performance studies of in vitro diagnostic medical devices are not affected.

Enter application form.

General requirements for applications (technical validation)

The following situations will block the processing of an initial application or amendment and will result in an immediate e-mail response to the applicant that the procedure cannot be further processed.

This applies to clinical investigations and performance studies.

  • 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

Clinical investigations according to Regulation (EU) 2017/745

If at least the documents above 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 will confirm that the notification is valid or to send a deficiency letter within 10 days .

The applicant is then also granted a period of 10 days for correction or submission of documents. In justified cases an extension can be requested for up to 20 days. 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 within 2 working days. 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 5 days.

For clinical investigations according to Article 70 (7) a) the valid submission will then be confirmed (at the latest) and the study can be initiated. For clinical investigations according to Article 70 (7) b), the 45-day period for the scientific and regulatory review begins thereafter.

If no response is received within the timelines of the Regulation or if the application cannot be completed, the application will be rejected.

Guidance and documents for clinical investigations according to Regulation (EU) 2017/745 - in preparation!

Guidelines and documents for studies according to Directives 90/385/EEC, 93/42/EEC and 98/79/EC

Other BASG forms for studies according to the Austrian Medical Devices Act

Newsletter on clinical trial statistics according to MPG

Email

Further inquiry note