Updated medical devices registration on the way for Poland
This article was originally published in RAJ Devices
Executive Summary
These legislative works were planned with a view to implementing into the Polish legal system the provisions of the Directive on the approximation of the laws of the Member States relating to active implantable medical devices (1). Currently, an entity that plans to introduce a medical device into the Polish market is obliged to fulfill the requirements stated in the national Medicinal Devices Act, which is generally in line with European law.