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Top Challenges the Medical Device Industry is Facing in the EU

The date of implementation of Regulation (EU) 2017/745 of 5 April 2017 on medical devices (MDR) is rapidly approaching, and medical device manufacturers are striving to ensure that they will meet the requirements and obligations imposed by the new rules by 26 May 2020, when the revised legal framework becomes fully applicable. Should the latter not be the case, they would seriously risk being placed out of the market since no grace period is foreseen, as discussed by Vincenzo Salvatore at BonelliErede.