As Brexit Day approaches, the outcome of the UK’s planned withdrawal from the EU seems more uncertain than ever. One thing is definitive: a no-deal (or Cliff Edge) Brexit would bring serious, immediate consequences for all industries operating cross-channel—especially the medical device industry.
However, you can take steps now to mitigate the impact to your company if a no-deal Brexit becomes reality. In this white paper, Emergo’s leading European compliance expert examines how a hard border between the UK and EU could affect the device industry and what manufacturers, patients, and health care providers can do to prepare. You will learn:
在欧盟销售的医疗器械需要拥有一个证明其符合欧盟医疗器械法规的CE认证标志。CE标志表明法定制造商已评估器械,并且符合MDR 2017/745下的一般安全和性能要求(GSPR)。法定制造商将验证是否符合所有相关的欧盟要求,并必须在其欧盟符合性声明(DoC)中声明这一点。此外,高风险器械(MDR下
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