CASubmissionOfApplication object
Responsible for study submission
Sponsor
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
Yes
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)
