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The EU notified body code of conduct: a key tool to avoid stricter regulation or too complex to enforce?

机译:欧盟通报机构的行为准则:避免严格监管或过于复杂以至于无法执行的关键工具?

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摘要

Now that an initial version of a code of conduct for notified bodies in the EU has been agreed, will it be enough to convince the European Commission that these testing and certification organisations are on their own able to raise standards across the sector to a sufficiently high level? In other words, will the code be enough to stop the commission and EU lawmakers from introducing tighter notified body-related legislation? If we knew the answers to these questions, we could go a long way towards predicting how radical the notified body-related revisions contained in the recast of the medical device directives that the commission is working on are likely to be.
机译:既然已经同意了欧盟公告机构的行为准则的初始版本,是否足以说服欧洲委员会,这些测试和认证组织有能力将整个行业的标准提高到足够高的水平?水平?换句话说,该法规是否足以阻止欧盟委员会和欧盟立法者引入更严格的与机构相关的通报立法?如果我们知道这些问题的答案,那么我们可以大大预测该委员会正在研究的医疗器械指令的重塑中所包含的与通知机构相关的修订有多大。

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