Positive opinion by relevant EC(s)
The application documentation is specified in Art 44(3) Medical Device Act of 2010 (en).
Art 44 of the Act on Medical Devices of 20 May 2010 (en)/ Dz.U. 2010, No 107, Item 679 (pl)
NB! A positive opinion of the competent EC is a prerequisite for application to the CA, as this is an integral part of the submission