Getting to grips with Directive 2007/47/EC: six months on

Neena Brizmohun

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Getting to grips with Directive 2007/47/EC: six months on

机译：掌握指令2007/47 / EC：六个月

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It has been just over six months since Directive 2007/47/EC came into force in the EU, bringing about major amendments to the legislation governing medical devices and introducing new requirements for manufacturers.Manufacturer nonconformity with the new requirements and the areas that are proving problematic were explored at the 7th annual symposium ofThe Organisation for Professionals in Regulatory Affairs, in London on 5 OctoberDirective 2007/47/EC was implemented on 21 March. It amended the Medical Devices Directive (93/42/EEC) and the Active Implantable Medical Devices Directive 90/385/EEC, and introduced a host of new duties for manufacturers and notified bodies endeavouring to show that a product complies with the essential requirements listed in the directives.

机译：自2007/47 / EC指令在欧盟生效以来已经过去了六个多月，对医疗器械法规进行了重大修订，并对制造商提出了新要求。在10月5日于伦敦举行的监管事务专业组织第七届年度研讨会上探讨了有问题的问题。3月21日实施了2007/47 / EC指令。它修订了医疗器械指令（93/42 / EEC）和有源可植入医疗器械指令90/385 / EEC，并为制造商和指定机构引入了一系列新职责，力求表明产品符合所列的基本要求在指令中。

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《Regulatory Affairs Journal- Devices》 |2010年第sepaaocta期|共2页
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Neena Brizmohun;
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正文语种 eng
中图分类药学;
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机译：掌握指令2007/47 / EC：六个月
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Getting to grips with Directive 2007/47/EC: six months on

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