《体外诊断器械法规》（简称“IVDR”，法规编号为《欧盟法规第2017/746号》）是一项立法，详细规定了制造商为了将体外诊断器械投放到欧洲联盟市场必须满足的各项要求。关于将《体外诊断器械法规》里规定的各项要求落实到贵方的业务里，本项培训课程旨在提供指引。
这项法规包含需要实施的详细要求，并且将影响到所有体外诊断器械制造商、进口商、经销商和欧盟授权代表。
《体外诊断器械法规》重点关注器械的安全性和有效性，并且强调上市前要求、符合性评估、上市后监测（“PMS”）和可追溯性。
The In Vitro Diagnostic Devices Regulation (IVDR 2017/746) is the legislation detailing the requirements which manufacturers have to meet to place in vitro diagnostic devices on the market in the European Union. This training course aims to offer guidance on implementation of the requirements stipulated in the IVDR into your business.
The Regulation contains detailed requirements that need to be implemented, and will affect all IVD manufacturers, importers, distributors, and EU Representatives.
The IVDR focusses on devices to be safe and effective, emphasizing pre-market requirements, conformity assessment, post-market-surveillance (PMS), and traceability.
课程收益How will I benefit?
- 为你的组织采取必要的步骤，以满足IVDR的要求
- 实施欧洲体外诊断设备条例的要求
- 指导和支持其他受IVDR影响的人和伙伴组织
- Take the necessary steps for your organization to meet the IVDR requirement
- Implement the requirements of the European In Vitro Diagnostics Devices Regulation
- Execute robust and compliant performance evaluation and post market follow up studies
- Guide and support other people and partner organisations affected by IVDR
目标对象Who should attend?
- 将在其组织内实施IVDR的RA、QM和QA专业人士
- 与认证有关的人员或积极参加CE认证项目的人员，包括研发科学家、生产人员、项目管理人员。
- 与IVD设备制造商合作的公司的工作人员，例如，作为分包商、关键供应商、OEM、授权代表、进口商、分销商、被审核者等。
- The course is especially suitable for:RA, QM, and QA professionals who will be implementing the IVDR within their organizations.
- Personnel concerned with certification or active in projects for CE-marking, including R&D scientists, production personnel, project management.
- Staff in contact with IVD Device manufacturers at companies which are partners to manufacturer, e.g., as subcontractor, crucial supplier, OEM, Authorized representative, importer, distributor, auditee.
课程亮点What's included?
你可以在适合自己的时间学习，你可以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.
