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Poland opens door to CE mark but cuts out national industry

This article was originally published in Clinica

Executive Summary

Medical devices that have been CE-marked in the EU can now be freely traded in Poland. This is the impact of the new Polish medical devices law which came into force on October 1 and transposes the EU's medical device directives, including the IVD Directive. There are many problem areas, however, and proposed amendments had already been put forward by the government to the Parliament even before the law took effect.

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