Medical Device Technical Documentation for MDRmeans a set of documents demonstrating a specific product’s compliance with the relevant CE marking legislation. The documentation must indicate the applicable product safety standards and requirements and cover the product’s design, manufacture, and operation.
TheTechnical Documentation当产品被置于欧盟市场时，必须通过市场监控机构进行检查，无论其地理位置如何。在某些情况下，还需要向通知机构提交技术文件以进行审查。
- AsCE Mark顾问for medical devices we’ll help you for the process of making a defined technical file with all the product details.
- We will help you in meeting European submission standards that state the product offered is in compliance with the exact requirements of European safety.
制造商或其指定的授权代表必须保持Technical Documentationfor at least fifteen years from the product’s last date of manufacture.
Medical Device Technical Documentation for MDRis a comprehensive description of your device intended to demonstrate compliance with European requirements. Compiling your technical file or design dossier is a critical step in Europe’s CE Marking process and a requirement for compliance with the Medical Devices Directive, In Vitro Diagnostic Medical Devices Directive 98/79/EC, or Active Implantable Medical Devices Directive 90/385/EEC.
The new Medical Devices Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) will change CE Marking and Technical File requirements for medical devices and IVDs.
Operon Strategist can assist you with the MDR/IVDR transition process.
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Medical Device Technical Documentation for MDR
The technical Documentation or dossier includes detailed information about the design, function, , use, claims, material of construction and clinical evaluation of your medical device.They are required for all classes of devices (Class I, I Measuring, I Sterile, IIa, IIb, and III), but no two files are the same because the type of device dictates the information included therein.除非您制造未提供无菌的I类设备并且没有测量功能，否则必须由通知的机构审查您的技术文件。了解如何组装这些信息并呈现它以供通知机构审查至关重要。
Medical Device Technical Documentation for MDR是制造商准备的摘要文档，以清晰，良好的组织，易于搜索和明确的方式，以展示所讨论的设备的安全性和性能。
TheMedical Device Technical Documentation for MDR必须提交通知机构或主管当局进行审查和批准。它应该最好用英语或欧盟成员国的官方语言进行。必须根据医疗设备的整个生命周期（低风险和15年的高风险设备）可根据要求提供。非欧盟制造商必须将文件与欧盟的授权代表（AR）保留。
MDR Technical Documentation
QA和监管团队成员总是困惑或发现难以确定计划为欧洲CE标记的产品的所需设备技术文件。188bet金搏宝滚球It is advised to remember that medical device technical file or documentation is all about your device to establish safety and performance.这意味着您无法将产品与不同的预期用途或不同的类或不同的施工材料，甚至不同的设计相结合。
在规划准备技术文件时，您需要考虑以下参数：
- 设备预期用途和使用指示
- Site of application
- Design change or major constructional changes
- State of the art
医疗器械技术文件
- Requirement & Identification as per CE MDR
- CE标记评估路径的风险分类与识别188bet金搏宝滚球
- 一般安全和性能要求评估。
- Systmatically organize and arrange Files and review.
- Clinical Evaluation documentation covering PMS, PMCF & PSUR
- 风险分析
- 医疗器械质量管理体系实施
人们可能会想到这一点Medical Device Technical Documentation for MDR是公开的，但实际上，本文件只能由当局和通知机构的医疗器械专家（TÜVSüd，BSI ......事实上，这是创建技术文件的目的。In the case of Class I (Self-certified) product, this document is still necessary in case of a review made by your competent authorities. So don’t think that because of self-certification you are not obliged to get it done.
In case of a product higher than pure class I, then there will be a need for a review made by your Notified Body that you must have selected. (This includes class I sterile, with measuring function or reprocessed)
Medical Device Technical Documentation for MDR is a core part of the process of approval of medical devices. Without this documentation, a manufacturer cannot perform the conformity assessment procedure with his medical device, thus, the product cannot be approved. Therefore, it is of great importance to maintain a technical documentation compliant with the standard. The new MDR adds further elements and requirements, which result in a notable extra effort for the technical documentation. Therefore, it is essential not to lose track with so many formalities.