-
Provide clients with the texts/points of interest
of all new laws and directives
-
Provide clients with all the necessary assistance
to obtain an CE mark
-
Examine and organise the printed material
(labels, leaflets etc.) in accordance with the current laws in
Italy
-
Examine the documentation sent by clients
wishing to apply for an CE mark
-
Present the Italian Ministry of Health with
the documentation regarding the CE Mark on behalf of the company
from the Notified Body
-
Translate the necessary documentation for
the Ministry or any other Italian entity
-
Follow the procedure for obtaining the CE
Mark and that of the ministerial notification
-
Prepare and follow up publicity material for
ministerial approval
-
Arrange for various certificates (Free Sale
Certificate, GMP, Certificate of Importation of dangerous substances,
Certificate of Importation of Samples for clinical trials or
other uses)
-
Contact the competent embassies for their
approval of Free Sale Certificates and any necessary sworn translations
-
Accompany personnel from companies to meetings
with personnel from the Ministry of Health or other Italian entities
