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From May 26, 2021, Regulation (EU) 2017/745 is fully applicable . The regulation amends the rules governing the medical device system, taking into account the developments of the last twenty years, with the aim of guaranteeing a solid regulatory framework, suitable for maintaining a high level of safety .
National authorities, notified bodies, manufacturers, economic operators, health institutions and the other parties involved will have to work together to improve the medical device system in the renewed regulatory framework envisaged by the regulation.
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