The enacted act on medical devices may harm the market

The lower chamber of the Polish parliament, Sejm, is working on the act on medical devices, which is to implement EU regulations into Polish law. However, representatives of the medical sector stress that many of the proposals go beyond the scope of the regulation and may hurt the market. Such regulations are penalties of several million, e.g. for a formal error in the marking of the product, even as minor as the lack of the manufacturer's address.

"If such a penalty, amounting to PLN 2-5…