《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.
课程收益How will I benefit?
- 帮助您了解欧盟《医疗器械法规》的主要要求和概念
- 帮助您向所在组织传达《医疗器械法规》规定之主要要求的影响
- Understand the key requirements and concepts of the European Medical Devices Regulation
- Communicate the impact of the key requirements introduced by the MDR to your organization
目标对象Who should attend?
- 从事法规事务的新手和在该领域承担更多职责的人员、以及并不熟悉欧盟《医疗器械法规》的法规事务专业人士；
- 和法规事务部门工作相关的人员，例如，高级管理者、以及质量管理/质量保证、研发、设计、制造、供应链、顾客服务和销售等部门的经理或者项目成员。
- 在与医疗器械制造商合作的组织（例如，分包商、供应商、原始设备制造商、授权代表、进口商、经销商、受审核方）里工作之职员。
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。
- New starters in Regulatory Affairs (RA) and those increasing their responsibility in this area, and RA professionals who are not familiar with the European MDR
- Anyone working with Regulatory Affairs departments, e.g. top management, manager or project member in QM/QA, R&D, design, manufacturing, supply chain, customer service and sales
- Staff working for organizations that partner with Medical Device manufacturers, e.g. as subcontractor, supplier, OEM, authorized representative, importer, distributor, auditee etc.
课程内容What will I learn?
By the end of the course, you’ll be able to:
- Communicate the key requirements and concepts within the Regulation
- Reference the necessary aspects to evaluate if and how your company is affected by MDR and to what extent
- Define the vocabulary used within the MDR
- Explain the structure and administration of the Regulation
- Recognize partners of manufacturers affected by the Regulation
- Describe the key steps of a conformity assessment
- Explain the main impacts on the quality management system (QMS) relating to MDR
- Recognize the requirements for post-market surveillance and updates
课程亮点 What's included?
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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.
