ECSubmissionFormat object
Format option(s)
Paper hardcopy
Standard application form available
Yes
Standard application form
Form for submission of the clinical investigation to the CA and the EC (Wzór wniosku o wydanie pozwolenia na prowadzenie badania klinicznego) is available on the CA website (in Polish).
The application form is also provided in Annex 1 (Załącznik Nr.1) of Health Minister Order 15 Nov 2010.
Guidance on submission format
The application documentation is specified in Art 44(3) (1-10) Medical Device Act 2010 (en)/ Dz.U. 2010 nr 107 poz. 679 (pl).
Applicable national legal framework/ Reference
Art 44(3) (1-10) Medical Device Act 2010 (en)/ Dz.U. 2010 nr 107 poz. 679 (pl)
Annex 1 (Załącznik Nr.1) of Health Minister Order 15 Nov 2010
