Clinical investigations with medical devices
As of 26.05.2022, Regulation (EU) 2017/746 for in vitro diagnostic medical devices ("IVDR") will apply, which also newly regulates performance studies of in vitro diagnostic medical devices. For this purpose, the BASG reporting form has been adapted accordingly. As of 26.05.2022, performance studies must therefore be submitted or reported to the BASG for approval using the updated form and in accordance with the requirements of the IVDR.
Ethics votes issued for these studies prior to 05/26/2022 will continue to be valid.
Ongoing performance studies under Directive 98/79/EC and applications already submitted may continue under the old regulations. Updating these forms as changes occur will continue to be possible. However, the creation of initial notifications according to Directive 98/79/EC will no longer be available as of 25.05.2022 for technical reasons.
The Federal Office for Safety in Healthcare has published updated guidelines for initial applications and amendments according to Regulation (EU) 2017/745 as well as new notification forms. These forms are mandatory for application.
Guidance documents are only available in German for the time being. Forms are bilingual.
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.
As of 28.01.2022, a new fee regulation of the BASG was put into force.
From this date new fees apply for
- clinical investigations of medical devices according to Regulation (EU) 2017/745
- performance evaluation studies of in-vitro diagnostics according to Directive 98/79/EC and
- amendments of clinical investigations of medical devices according to Directives 90/385/EEC and 93/42/EEC .
The tariffs for academic clinical investigations of medical devices and performance evaluation studies of in-vitro diagnostics are thus no longer reduced! The same fees for initial and amendment applications apply as for commercial studies.
Please refer to the BASG fee schedule for the current fees.
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.
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.
- Application for approval or notification of a clinical investigation according to Regulation (EU) 2017/74507/03/2022
- Guidance for classification and reporting of amendments during the clinical investigation07/03/2022
- Notification of an amendment requiring approval pursuant to Article 75 of Regulation (EU) 2017/74525/02/2022
- Changes to the investigation with significance for the regulatory oversight25/02/2022
- Information requirements of the sponsor pursuant to Article 77 of Regulation (EU) 2017/74525/02/2022
- Notification of completion of a clinical investigation according to Article 77 of Regulation (EU) 2017/74525/02/2022
- Application form for significant changes during the clinical investigation/performance evaluation.30/03/2016
- SAE Reporting Form| 27 KBReporting of serious events with a causal relationship pursuant to Article 80(2), Regulation (EU) 2017/745, and Article 76(2), Regulation (EU) 2017/746.11/01/2021
- 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
- Overview of initial applications, procedures and notifications from 2010 to 201925/08/2020