歐盟更新了關于公告機構要求的指南文件

2019-10-24 10:58 ?閱讀數:198 標簽:

歐盟委員會醫療器械協調小組(MDCG)最近在其關于公告機構(NB)要求的指南文件中增加了約6頁的問答內容。

 

該指南文件于今年6月份首次發布,對其進行更新之際,已有5家公告機構獲得歐盟醫療器械法規(MDR)框架下的指定,同時也有1家公告機構獲得歐盟體外診斷醫療器械法規(IVDR)框架下的指定。

 

關于公告機構“組織要求和一般要求”方面,新修訂版文件中的大部分信息與首次發布的文件相同,但就“資源要求”中的評審人員資質方面,新修訂版文件增加了對“兩年專業經驗”(經驗來自符合性評估機構(CAB)內部的情況下)的解釋。

 

該指南文件解釋道,當基于相關背景教育的專業經驗僅通過評審人員在符合性評估機構內部實施的活動加以證明時,該類經驗應至少有2年。如果一個人根據指令(93/42/EEC、90/385/EEC、98/79/EC)在至少2年內對相關器械(或待評估方面)或等同器械進行了至少5次完整的技術文件評估,則可將其視為附錄VII第3.2.5節所指的有效工作經驗。

 

該指南文件還對以下方面進行了解釋:1)MDR第36條第1款/IVDR第32條第1款中的術語“雇用(employed)”;2)“可永久獲得具有相關臨床專業知識的人員(permanent availability of personnel with relevant clinical expertise)”;3)“擁有或可以獲得(履行MDR附錄VII第3.1.1節所述任務所需的)所有設備和設施”。

 

此外,該指南文件還包括對供應商和分包商的審核標準、MDR第58條/IVDR第53條(公告機構的自愿變更)中針對簽發證書的原公告機構向變更后的公告機構進行移交后的有關符合性評估的適用要求、以及在公告機構評估和決策過程中內部或綜合臨床醫生的角色職責的相關說明。

 

針對變更需要符合性評估機構事先批準的相關問題,新修訂版文件表示,“為了完全符合所有相關要求,符合性評估機構必須將程序形成文件,其中需要規定在變更實施前如何對變更進行通知和評估,以及如何將評估形成文件。同時,符合性評估機構需要在其程序文件中明確說明此類變更獲批后何時對先前所簽發的證書進行補充,這一點尤為重要。

 

該指南文件還回答了以下問題:“重新認證的適用要求是什么?


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?”





來源:RAPS

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

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