欧盟MDR的可追溯性要求必须确保医疗设备开发和市场后活动的所有阶段之间的可追溯性。2021年5月，欧洲的医疗设备法规（EU MDR）将生效，取代当前现有的现有医疗设备指令（MDD）。
这种监管变化在欧洲市场的影响是巨大的，目前在欧盟出售了大约500,000种不同的医疗设备。负责这些设备的实体有望遵循新的，更严格的要求对法规的要求。
- 作为CE Mark顾问对于医疗设备，我们将为您提供使用所有产品详细信息的定义技术文件的过程。
- 我们将帮助您满足欧洲提交标准，即该产品所提供的产品符合欧洲安全的确切要求。
特别重要的领域是欧盟MDR对闭环质量系统可追溯性的优先排序。当实现这一目标时，制造商可以大大降低风险，例如与设备危害相关的风险，这些危害对欧洲老龄化的人口构成威胁越来越大。
General-purpose systems use disparate data and a siloed approach that requires teams to use tribal knowledge in order to hold the quality system together. Modern medical device quality management systems (MDQMS) allow teams to demonstrate closed-loop traceability and automate quality events to improve quality management throughout the product lifecycle, which ensures device quality and patient safety.
Looking Forward To CE Marking Process For Medical Devices ?
我们帮你在做的过程中定义comprehensive technical file with all product details required for CE marking.
欧盟MDR需要什么医疗设备的识别和可追溯性？
The EU MDR requires total lifecycle traceability between all stages of medical device development and post-market activities. Demonstrating traceability throughout the product lifecycle, known as closed-loop traceability, is a revolutionary approach to quality management that many industry professionals never thought possible.
为了使系统实现完整的可追溯性，您必须能够看到，理解和传达质量系统中的数据和关系。不幸的是，实现总生命周期可追溯性仍然对许多公司构成挑战：每四个医疗设备公司中，只有一名“非常自信”在面对未经宣布的审计时可以证明这一要求。
This is particularly concerning given the fact that the EU MDR mandates all third-party suppliers and manufacturers involved at any stage of a medical device’s lifecycle to undergo an audit of their QMS to demonstrate compliance with traceability requirements. To keep track of devices through every lifecycle stage, a device identifier will be assigned and all production series will be marked with a production identifier. These tracking measures satisfy the new mandate for Unique Device Identification (UDI), which is entered into the EUDAMED database.
The purpose of EUDAMED is to create an accessible repository of device-related information for patients, regulators, notified bodies, and manufacturers to access data for medical devices being marketed in the EU and help improve overall post-market surveillance.
UDI information must:
- Be placed on the medical device’s package or label.
- 遵循全球使用的格式。
- 包括EC代表的详细信息，包括名称，地址和符号。
- 以电子方式发布到制造商的网站，也可以印刷。
法规中引入的另一个重大变化是新的经济运营商系统。在欧盟MDR的领导下，经济运营商现在包括制造商，授权代表，进口商和分销商。在整个医疗设备供应链过程中，这些实体将承担责任水平的提高。
To ensure traceability and safety for devices being marketed in Europe, EU MDR imposes an entirely new set of requirements for importers and distributors, specifically. In addition, new requirements for economic operators include verification of compliance, cooperation in complaint handling and field safety corrective actions, and, of course, cooperating with manufacturers and Competent Authorities in device traceability.
Why does quality system traceability matter?
A study by Stericycle Expert Solutions found that poor software design was a major culprit behind a quarter of medical device recalls in 2017 alone. With patient lives at stake, the need for quick identification of flaws and transparent, interconnected quality systems is critical.
Achieving closed-loop traceability within a MDQMS can be made simple with software capabilities that automate every pre- and post-market process. Companies using this type of purpose-built quality management solution will benefit from having a reliable, trackable system where they can leverage data-driven insights to make better decisions that allow them to outperform the competition.
闭环可追溯性为医疗设备制造商提供的另一个关键优势是简化的审计准备时间表。例如，通过提供实时审核员要求的任何记录或文件的可见审计跟踪，闭环可追溯性消除了准备问题。在整个设备的生命周期中跟踪和正确记录文档并具有完全透明度的所有信息的能力是一个关键的竞争优势，因为它提高了效率并减少了与不合规性相关的昂贵费用的机会。
我如何表现出闭环的可追溯性？
随着现代化质量解决方案的出现，医疗设备专业人员不再被迫使用断开的系统，而仅依靠他们的记忆来维护文档，跟踪变更和浏览质量信息。欧盟MDR是世界上其他地区中第一个对可追溯性提出严格要求的法规，但这肯定不是最后一个。对于任何计划进入其他国际市场的制造商来说，这尤其重要。
Rather than relying on experience and disparate systems to demonstrate complete closed-loop traceability and satisfy EU MDR requirements, utilize a medical device specific QMS solution that connects the entire quality ecosystem using machine-learning capabilities to provide manufacturers complete transparency while executing a data-driven approach to decision-making in the device lifecycle.
