我想深入探讨医疗器械开发中最关键的概念之一：SOTA。新发布的指南MDCG 2021-5 Rev. 1 详细阐述了这一概念。对于质量和监管事务专业人员来说，该指南为解释和应用医疗器械合规中的SOTA提供了重要指导。

SOTA要点：

概念澄清：

SOTA代表了当前的技术能力水平，以及从科学、技术和经验的综合研究成果中得出的公认临床实践。它代表的是公认的良好实践，而不是最先进的技术解决方案。这对于使产品开发符合监管期望至关重要。以下是指南中引用的一些定义：

- “State of the Art: Developed stage of technical capability at a given time as regards products, processes, and services, based on the relevant consolidated findings of science, technology, and experience.

NOTE 1: The state of the art embodies what is currently and generally accepted as good practice in technology and medicine. The state of the art does not necessarily imply the most technologically advanced solution. The state of the art described here is sometimes referred to as the ‘generally acknowledged state of the art’. (Modified from ISO/IEC Guide 2:2004)” (IMDRF/GRRP WG/N47 FINAL:2018 Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices, p. 11).

-“State of the art: developed stage of technical capability at a given time as regards products, processes and services, based on the relevant consolidated findings of science, technology and experience.

Note: The state of the art embodies what is currently and generally accepted as good practice in technology and medicine. The state of the art does not necessarily imply the most technologically advanced solution. The state of the art described here is sometimes referred to as the ‘generally acknowledged state of the art’ [Source: ISO/IEC Guide 63:2019, 3.18]” (EN ISO 14971:2019 Medical devices - Application of risk management to medical devices, p. 6).

法律框架：

欧盟立法要求在满足安全和性能要求时考虑SOTA。但必须注意的是，"考虑"并不等于"遵守"。SOTA是一个动态的、非法律定义的概念，必须通过知情的解释和应用将其纳入合规战略：

-“The concept of essential requirements is based on the assumption that the harmonised standards reflect generally acknowledgeable state of the art and the ESO review standards regularly in accordance with the relevant standardisation request” (“The ‘Blue Guide’ on the implementation of EU product rules 2022, section 4.1.2.4., p. 53).

-“The most recent editions of standards published by the standardisers should be considered as reflecting state-of-the-art, regardless of the OJ referencing” (COM statement, Minutes of the meeting of the MDCG Subgroup on Standards held on 20 May 2019, item 3, p. 1).

-“The current knowledge/ state of the art in the corresponding medical field, such as applicable standards and guidance documents, information relating to the medical condition managed with the device and its natural course, benchmark devices, other devices and medical alternatives available to the target population” (MEDDEV 2.7/1 revision 4 - Clinical evaluation: a guide for manufacturers and notified bodies under Directives 93/42/EEC and 90/385/EEC, section 7., p. 16).

指南文件和标准：

MDCG指南强调了为SOTA提供信息的多种来源，包括：

-统一标准：定期审查和更新，反映SOTA。

-最新版本的标准：将最新版本的标准视为反映SOTA的标准，而不论是否参考了 OJ。

-综合参考资料：Blue Guide和MEDDEV 2.7/1 等文件提供了详细的定义和实际案例，对合规策略非常宝贵。

制造商的责任：

虽然标准的使用是自愿的，但制造商有责任确保产品符合欧盟法规。这需要采取细致入微的方法，利用标准来证明合规性，同时根据需要整合其他技术和临床证据。标准提供了一条简化的合规途径，但不是强制性的；以下是指南的解释：

-“In order to have a clear reference, especially with respect to the practical implementation of the concept, it is commonly considered that the most recent versions of standards with the technical solutions they contain reflect the ‘state of the art’. However, the mere compliance with the most recent version of a standard the reference of which has not been published in the OJEU does not automatically imply compliance with the requirements of the applicable EU legislation, if no further evidences are provided in the technical documentation of the product. Actually, ‘state-of-the-art’ standards as such do not confer any presumption of conformity if their references are not cited in the OJEU, as harmonised European standards developed by the ESOs on the basis of a standardisation mandate or request issued by the Commission” (MDCG 2021-5 Rev. 1, p. 18).

作为制造商，我该做些什么？

-保持更新：定期查看最新标准和指南文件。

-记录合规性：全面记录您的产品在技术和临床方面如何达到SOTA。

-临床评估：通过考虑适用的标准和指南文件、与器械管理的医疗条件相关的信息以及基准器械，确保您的临床评估符合当前的技术水平。

-风险管理：根据 EN ISO 14971:2019 实施强有力的风险管理实践，以解决所用标准与SOTA之间的差距。

-整体方法：为确保合规，应结合使用统一标准、行业最佳实践和内部协议。不要完全依赖最新标准。

-与公告机构合作：主动与公告机构接触，了解他们的期望，确保您的文件和实践符合监管要求。