CASubmissionOfApplication object

Responsible for study submission

Legal representative domiciled in the EU/EEA

Prerequisites for submission

Positive opinion by relevant EC(s)
Appropriate insurance

Guidance on submission of application

A checklist on application dossier and detailed guidance on application procedure is available on the BASG website in German and English:
ENGLISH: L I100_Required documentation MP (en) + L I99_Guidance Document for Clinical Investigations with Medical Devices (en)
GERMAN: L I07 Unterlagen klinische Proofing MP (de) + Leitfaden für klinische Prüfung mit Medizinprodukten (de)

National legal framework in place


Applicable national legal framework/ Reference

Art 40 MPG

Additional Information

Combination studies: 2 separate applications required for combinations studies (1 according to AMG and 1 according to MPG)