Clinical investigations with medical devices
The electronic registration form is mandatory for a valid initial application a clinical investigation of a medical device according to Regulation (EU) 2017/745 or a performance study of an in vitro diagnostic according to Regulation (EU) 2017/746.
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
Until updated guidance documents and forms are available, the national procedural rules described in the guidance documents for clinical investigations with medical devices shall also be applied for performance studies with in vitro diagnostics. Where legal rules of Regulation (EU) 2017/745 are referenced, the corresponding reference of Regulation (EU) 2017/746 shall be used.
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) MDR or 66 (7) a) IVDR 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) MDR or Article 66 (7) b) IVDR, the 45-day period for the scientific and regulatory review begins thereafter.
If no response is received within the timelines of the Regulations 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
- SAE Reporting Form| 381 KBReporting of serious events with a causal relationship pursuant to Article 80(2), Regulation (EU) 2017/745, and Article 76(2), Regulation (EU) 2017/746.02/10/2022