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This volume 2 of the manual "Everything you need to know about the new European regulation on medical devices" is aimed at all economic operators in the medical devices field. It aims to help professionals in the medical devices industry to understand the new European regulation on medical devices, to enlighten them on the major developments, and to present in a summary and clear manner the steps to be taken to mark CE a medical device according to the new European Regulation (EU) 2017/745 while taking into account the Regulation (EU) 2020/561 of 23 April 2020 which amends it.