According to the Electronic Submission Ordinance (EEVO) 2011 § 2 para. 3 as amended, applications, notifications, reports and other documents for clinical evaluations and performance studies according to Section 3 of the Medical Devices Act must be submitted to the Federal Office for Safety in Health Care exclusively electronically.

Postal submissions are neither time-preserving nor deadline-inhibiting. If the department is notified about a postal submission, the applicant is requested to submit electronically by written request. Any deadlines will only begin to run again once electronic documents have been duly received.

The BASG guidance is currently under revision and till then also include this requirement.

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.

Enter application form.

The initial application or amendment application to the Federal Office must contain the final favourable ethics vote for the application. The clinical investigation plan (CSP), investigator's brochure and patient information leaflet(s) mustcomply with the versions approved by the ethics committee.

A final favourable ethics vote means that the evaluation of the documents by the Ethics Committee is completed and no further changes need to be made. A preliminary ethics vote or a processing notification does not count as a final ethics vote.

Submission to the responsible ethics committee during the ongoing procedure is not recommended, as it is usually not possible to submit the final favourable ethics committee opinion within MDR/IVDR timelines, which leads to rejection.

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. Please not that only electronic submissions will be processed (see above).

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.