欧盟更新了关于公告机构要求的指南文件

2019-10-24 10:58 阅读数：3287 标签：

欧盟委员会医疗器械协调小组（MDCG）最近在其关于公告机构（NB）要求的指南文件中增加了约6页的问答内容。

该指南文件于今年6月份首次发布，对其进行更新之际，已有5家公告机构获得欧盟医疗器械法规（MDR）框架下的指定，同时也有1家公告机构获得欧盟体外诊断医疗器械法规（IVDR）框架下的指定。

关于公告机构“组织要求和一般要求”方面，新修订版文件中的大部分信息与首次发布的文件相同，但就“资源要求”中的评审人员资质方面，新修订版文件增加了对“两年专业经验”（经验来自符合性评估机构（CAB）内部的情况下）的解释。

该指南文件解释道，当基于相关背景教育的专业经验仅通过评审人员在符合性评估机构内部实施的活动加以证明时，该类经验应至少有2年。如果一个人根据指令（93/42/EEC、90/385/EEC、98/79/EC）在至少2年内对相关器械（或待评估方面）或等同器械进行了至少5次完整的技术文件评估，则可将其视为附录VII第3.2.5节所指的有效工作经验。

该指南文件还对以下方面进行了解释：1）MDR第36条第1款/IVDR第32条第1款中的术语“雇用（employed）”；2）“可永久获得具有相关临床专业知识的人员（permanent availability of personnel with relevant clinical expertise）”；3）“拥有或可以获得（履行MDR附录VII第3.1.1节所述任务所需的）所有设备和设施”。

此外，该指南文件还包括对供应商和分包商的审核标准、MDR第58条/IVDR第53条（公告机构的自愿变更）中针对签发证书的原公告机构向变更后的公告机构进行移交后的有关符合性评估的适用要求、以及在公告机构评估和决策过程中内部或综合临床医生的角色职责的相关说明。

针对变更需要符合性评估机构事先批准的相关问题，新修订版文件表示，“为了完全符合所有相关要求，符合性评估机构必须将程序形成文件，其中需要规定在变更实施前如何对变更进行通知和评估，以及如何将评估形成文件。同时，符合性评估机构需要在其程序文件中明确说明此类变更获批后何时对先前所签发的证书进行补充，这一点尤为重要。”

该指南文件还回答了以下问题：“重新认证的适用要求是什么？”

英文原文

MDCG Updates Q&As on Requirements for Notified Bodies

The European Commission’s Medical Device Coordination Group (MDCG) recently added about six pages worth of questions and answers (Q&As) to its document on requirements relating to notified bodies (NBs).

The update to the document, which was first released in June, comes as five NBs have been designated under the Medical Device Regulation (MDR), while one NB has been designated under the In Vitro Diagnostic Regulation (IVDR).

Most of the information related to organizational and general requirements for NBs is the same as the previous document, but under the resources requirements section, new information is included on the meaning of "two years' professional experience" in cases where the experience has been gained within a CAB.

The document explains that when professional experience, based on relevant background education, “is to be proven by activities only within a CAB, this experience should have been gained during at least two years. As a guideline if one individual has carried out at least five full technical documentation assessments of devices in the relevant code (or aspects to be assessed) or under the equivalent code under the Directives, during at least 2 years, this can be accepted as a valid work experience within the meaning of 3.2.5 of Annex VII.”

The guidance also explains the meaning of the term “employed” in MDR Article 36(1)/IVDR Article 32(1), as well as the meaning of “permanent availability of personnel with relevant clinical expertise,” what it means to“possess or have access to all equipment and facilities” needed to perform tasks within the meaning of Section 3.1.1 of Annex VII of the MDR.

It also includes descriptions of the criteria for auditing suppliers and subcontractors, the applicable requirements for voluntary certificate transfer under MDR Article 58/IVDR Article 53 and the role of the internal or integrated clinician in the NB’s assessment and decision-making process.

“In order to fully comply with all the relevant requirements the CAB must have documented procedures defining how different changes need to be notified and assessed prior to their implementation and how the assessment will be documented. In particular, the CAB will define in its procedures when the approval of such changes will take the form of a supplement of the previously issued certificate,” the updated document says in response to a question on changes needing prior approval by the CAB.

The document also answers the question: “What are the applicable requirements for re-certification?”

来源：RAPS

原文链接：https://www.raps.org/news-and-articles/news-articles/2019/10/mdcg-updates-qas-on-requirements-for-notified-bod

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