The application for notification of medical product in Poland should contain in particular:
1) the name and address of the reporting entity;
2) the trade name of the product;
3) the generic name of the product;
4) the name and address of the manufacturer;
5) brief description of the product and its intended application, in polish and in english;
6) class of medical device and applied classification rules;
7) information on whether the in vitro diagnostic medical device is a List A, List B, self-control product, performance evaluation product or new product;
8) information whether the product is a custom made item;
9) the number of the notified body that participated in the conformity assessment;
10) GMDN product code or other recognized nomenclature of medical devices together with the name of the nomenclature.
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