Caldwell：欧盟医疗器械法规(MDR)如何重塑医疗技术行业（2023）（中译版）（13页）.pdf

1、Au Revoir,Innovation?How the EU MDR Is Reshaping the MedTech IndustryCompanies have been scrambling to comply with the new rules.Notified bodies have struggled to cope with the unprecedented workload.Leaders have voiced growing concerns over how the regulations are being implemented.Panic has spread

2、 over potential device shortages.Final dates for compliance have been pushed backand then pushed back again.Dire predictions have been made about the future of innovation and investment in Europe.Now the dust appears to be settling.Most companies look set to meet the revised deadlines and the backlo

3、g of product approval is slowly starting to ease.While it may be too early to describe the MDR as the new normal,there is no doubt that the regulations are here to stay.How do boards and investors feel about recent events and about the future?What consequences will there be for Europe in the medium

4、to long term?Will regulatory affairs play a more significant role in companies from now on?Who,if anyone,has benefited from the introduction of the MDR?We have sought to answer these questions through extensive research and numerous interviews with leaders within the medtech industry in Europe and t

5、he United States.This paper weaves together their wide-ranging views and insights to chart the ongoing journey of the MDR and gauge its impact on the industry in the past,present,and future.IntroductionOn 26 May 2017,the EUs Medical Device Regulation(MDR)came into force,replacing the Medical Device

6、Directive(MDD)of 1993 with effect from 26 May 2021.The medtech industry has been in turmoil ever since.12Au Revoir,Innovation?How the EU MDR Is Reshaping the MedTech IndustryBackgroundThe EU Medical Device Directive:Why,What,and WhenEurope is one of the largest and most important markets for medical