Poland takes steps to amend poorly disguised PMA (premarket approval) rules
This article was originally published in Clinica
Executive Summary
The Polish health ministry is now redrafting its medical device registration rules which were supposed to come into force on September 30 but which were rejected following an outcry from industry. This is a huge relief to manufacturers who had feared that the new rules were a poorly disguised attempt at a premarket approval scheme (see Clinica No 1058, p 9), which was intended to persist into the period when Poland becomes an EU member.