Significant Obligations If Poland’s compliance requirements for medical device importers an

Significant Obligations

If Poland’s compliance requirements for medical device importers and distributors prompt similar requirements in other EU markets, those firms will face some heavy lifting in order to meet such requirements.

Chapter 3 of the law, Obligations of Importers and Distributors, enumerates various obligations importers and distributors will have to meet to participate in the Polish medical device market. Some firms likely already are performing some of these tasks as part of their business processes, but not all.

Importers, for example, must ensure prior to commercializing a device that the product’s manufacturer or authorized representative conducted an adequate conformity assessment; that the manufacturer already has designated an authorized representative for the device, that the device has achieved CE Marking, and that device information from the manufacturer meets essential requirements. It is the Polish importer or distributor who is required to notify the Polish Competent Authority of Class IIa, IIb, and III medical devices as well as IVDs.

Polish importers and distributors also are more accountable for product safety according to the Polish law. First, Polish importers and distributors (by definition with local presences in Poland) are required to cooperate with the office of the president as well as the manufacturers and authorized agents of their devices in the event of safety issues and recalls. Refusal on the part of Polish importers or distributors to cooperate in this regard will result in penalties.

Any information firms receive from patients and users regarding negative side effects of their devices must be passed on to the products’ manufacturers or authorized representatives as well as the Competent Authority chairperson. Firms also must keep documentation establishing the origin and identification of a device for five years following introduction of that product to the Polish market.

In addition, importers and distributors must now meet added responsibilities in terms of ensuring proper labeling andinstructions for use, as well as proper storage and transport of devices. These firms also must meet significant conformity assessment requirements for products they market in Poland, and maintain documentation of assessments for five- or 15-year periods depending on a particular device’s nature.