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我想深入探討醫(yī)療器械開發(fā)中最關(guān)鍵的概念之一：SOTA。新發(fā)布的指南MDCG 2021-5 Rev. 1 詳細(xì)闡述了這一概念。對(duì)于質(zhì)量和監(jiān)管事務(wù)專業(yè)人員來說，該指南為解釋和應(yīng)用醫(yī)療器械合規(guī)中的SOTA提供了重要指導(dǎo)。

SOTA要點(diǎn)：

概念澄清：

SOTA代表了當(dāng)前的技術(shù)能力水平，以及從科學(xué)、技術(shù)和經(jīng)驗(yàn)的綜合研究成果中得出的公認(rèn)臨床實(shí)踐。它代表的是公認(rèn)的良好實(shí)踐，而不是最先進(jìn)的技術(shù)解決方案。這對(duì)于使產(chǎn)品開發(fā)符合監(jiān)管期望至關(guān)重要。以下是指南中引用的一些定義：

- “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：

歐盟立法要求在滿足安全和性能要求時(shí)考慮SOTA。但必須注意的是，"考慮"并不等于"遵守"。SOTA是一個(gè)動(dòng)態(tài)的、非法律定義的概念，必須通過知情的解釋和應(yīng)用將其納入合規(guī)戰(zhàn)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).

指南文件和標(biāo)準(zhǔn)：

MDCG指南強(qiáng)調(diào)了為SOTA提供信息的多種來源，包括：

-統(tǒng)一標(biāo)準(zhǔn)：定期審查和更新，反映SOTA。

-最新版本的標(biāo)準(zhǔn)：將最新版本的標(biāo)準(zhǔn)視為反映SOTA的標(biāo)準(zhǔn)，而不論是否參考了 OJ。

-綜合參考資料：Blue Guide和MEDDEV 2.7/1 等文件提供了詳細(xì)的定義和實(shí)際案例，對(duì)合規(guī)策略非常寶貴。

制造商的責(zé)任：

雖然標(biāo)準(zhǔn)的使用是自愿的，但制造商有責(zé)任確保產(chǎn)品符合歐盟法規(guī)。這需要采取細(xì)致入微的方法，利用標(biāo)準(zhǔn)來證明合規(guī)性，同時(shí)根據(jù)需要整合其他技術(shù)和臨床證據(jù)。標(biāo)準(zhǔn)提供了一條簡(jiǎn)化的合規(guī)途徑，但不是強(qiáng)制性的；以下是指南的解釋：

-“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).

作為制造商，我該做些什么？

-保持更新：定期查看最新標(biāo)準(zhǔn)和指南文件。

-記錄合規(guī)性：全面記錄您的產(chǎn)品在技術(shù)和臨床方面如何達(dá)到SOTA。

-臨床評(píng)估：通過考慮適用的標(biāo)準(zhǔn)和指南文件、與器械管理的醫(yī)療條件相關(guān)的信息以及基準(zhǔn)器械，確保您的臨床評(píng)估符合當(dāng)前的技術(shù)水平。

-風(fēng)險(xiǎn)管理：根據(jù) EN ISO 14971:2019 實(shí)施強(qiáng)有力的風(fēng)險(xiǎn)管理實(shí)踐，以解決所用標(biāo)準(zhǔn)與SOTA之間的差距。

-整體方法：為確保合規(guī)，應(yīng)結(jié)合使用統(tǒng)一標(biāo)準(zhǔn)、行業(yè)最佳實(shí)踐和內(nèi)部協(xié)議。不要完全依賴最新標(biāo)準(zhǔn)。

-與公告機(jī)構(gòu)合作：主動(dòng)與公告機(jī)構(gòu)接觸，了解他們的期望，確保您的文件和實(shí)踐符合監(jiān)管要求。