Clinical investigations with medical devices
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
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.
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.
Due to current events, all attachments should be submitted exclusively by e-mail to firstname.lastname@example.org. For details we refer to the BASG submission guidance.
- Overview of initial applications, procedures and notifications from 2010 to 201925/08/2020
- 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