APPLICATION FOR NOTIFICATION OF MEDICAL PRODUCT IN POLAND

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.

Experienced in consulting individual and corporate clients on medical law, polish lawyers strive to provide our clients with the best help they can get. Polish lawyers' practice of law involves giving legal advices on public procurment procedures as well as representing clients in court proceedings and medical procedures.

If you are looking for a professional legal aid of legal advisors on medical law in Poland, please take a look at our offer here.

ABOUT POLISH LAWYER

MFLegal - an office of polish lawyer provides advice on all legal issues, domestic and international for business or private activity.

Experienced in consulting individual and corporate clients in Poland, we focus on finding based on trust, innovative and high quality solutions. Don't hesitate and write to us! We kindly will supply you any needed information.

CONTACT

Address:

Karola Marcinkowskiego 1/2, 85-056 Bydgoszcz

Tel.:

(+48) 50-81-37-606

Email:

kontakt@mflegal.pl