ECSubmissionOfApplication object
Responsible for study submission
Sponsor
Prerequisites for submission / approval
Positive opinion by relevant EC(s)
Applicable national legal framework/ Reference
Art 49 Medical Device Act 2010 (en) / Dz.U. 2010 nr 107 poz. 679 (pl)
Additional Information
The sponsor shall submit the request for approval of the clinical investigation to the local REC of the trial site. In case of a multi-centre investigation it shall be submitted to the EC where the coordinating clinical investigator has its registered office.
