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《医疗器械法规》是一项立法,其详细规定了制造商必须满足的各项要求,以便将医疗器械投放到欧盟的市场。
这项立法影响到所有的医疗器械制造商、进口商、经销商和欧盟授权代表。受到影响的还有:分包商和供应商、以及并不用于医疗用途的某些器械(例如,用于美体塑形的器械、以及用于改变眼睛颜色、但并不矫正视力的隐形眼镜)的制造商。
《医疗器械法规》把重点放在器械安全性和性能上,强调的领域包括:上市前要求、符合性评估、质量管理体系、上市后监督(“PMS”)、透明度和可追溯性。这些要求还影响到(供应商)审核和法规监管,引入了进行互动的合作伙伴,并且增加了沟通需求和义务(例如,合同、报告、文件化和信息公开)。
本课程将讲授欧盟《医疗器械法规》的主要概念。为了将医疗器械投放到欧盟市场,它们都需要按照《医疗器械法规》的要求接受“符合性评估程序”。通过本课程,您将了解《医疗器械法规》里规定的各项要求。
The Medical Devices Regulation is the legislation detailing the requirements that manufacturers have to meet to place medical devices on the market in the European Union.
The Regulation affects all medical device manufacturers, importers, distributors and EU Representatives. Subcontractors/suppliers are also affected, as well as manufacturers of some devices without a medical purpose (for example, devices used for esthetical body modification, contact lenses to change eye colour without correcting vision, etc.).
The MDR focusses on device safety and performance, emphasizing pre-market requirements, conformity assessment, quality management aspects, Post Market Surveillance (PMS), transparency and traceability. The requirements also affect (supplier) audits and governmental control; introduces new partners to interact with, and increases communication needs and obligations (e.g. contracts, reporting, documentation, and publication of information).
This course conveys key concepts of the European Medical Devices Regulation. All medical devices will need to undergo a Conformity Assessment Procedure based on the MDR requirements in order to be placed on the European Union market. You will gain understanding of the requirements stipulated within MDR.
By the end of the course, you’ll be able to:
注意:本课程并不包括“体外诊断器械”。如果您需要了解更多的详细信息(例如,实施要求),请参阅下面的“相关培训”部分。
你可以在适合自己的时间学习,从任何支持互联网的设备上24/7访问该课程。
You can study in your own time when it suits you, and you can access the course from any internet-enabled device 24/7.
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