Poland Forges a Path A recent transposition by the Polish Competent Authority, the Office for Reg

Poland Forges a Path

A recent transposition by the Polish Competent Authority, the Office for Registration of Medical Products, Medical Devices and Biocidal Products, of the MDD incorporating the new New Approach, however, may offer a path toward a more uniform application of the framework for medical devices, including a blueprint for how to expand the Directive’s scope to include all four economic operators.

The Polish Competent Authorities’ transposition of EU medical device directives—the Act of May 20, 2010, on Medical Devices, Official Journal Laws 2010, No. 107, Item 679—includes the MDD as well as the AIMDD and the In Vitro Device Directive (IVDD). The Polish transposition occurred only recently and went into effect in September 2010. Despite—or because of—that delay, the Polish law provides the first instance in the EU of formalized obligations imposed upon importers and distributors of medical devices. Whether or not other member states rely on Poland as a precedent to fashion their own requirements under the updated New Directive remains to be seen, but the fact that the authorities in Poland have set up a substantial and rigorous set of rules for importers and distributors should not go unnoticed by regulators, notified bodies or industry.