《MDR》Article 107

本页给出《MDR》Article 107的条文原文(摘自官方发布文本),并说明其含义与落到 PDF 文档上的处理要点。

一、条文原文

MDR Article 107

Conflict of interests 1.   Members of the MDCG, its sub-groups, and members of expert panels and expert laboratories shall not have financial or other interests in the medical device industry which could affect their impartiality. They shall undertake to act in the public interest and in an independent manner. They shall declare any direct or indirect interests they may have in the medical device industry and update that declaration whenever a relevant change occurs. The declaration of interests shall be made publicly available on the Commission website. This Article shall not apply to the representatives of stakeholder organisations participating in the sub-groups of the MDCG. 2.   Experts and other third parties invited by the MDCG on a case-by-case basis shall declare any interests they may have in the issue in question.

二、涉及的处理要点

archive:涉及记录的留存与保管。文档层面应按期限留存且保证可检索、可追溯;版本另存而非覆盖,避免破坏流转留痕。

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涉及该条文的文档处理需求,可从对应的处理能力开始。

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三、文档处理清单

  1. 按留存期限建立台账并定期复核
  2. 版本另存,禁止覆盖原始记录
  3. 合并成套并连续编页便于检索
条文摘录来源:官方发布的法规文本·整理日期 2026-09-02

本页条文为官方文本原文摘录,解释与文档建议基于该条文实际涉及的内容生成。条文引用以官方最新有效文本为准。

免责声明:本页仅供文档处理作一般性参考,不构成法律意见、合规咨询或专业服务。具体适用请咨询具备资质的专业人士,并以届时最新有效的法律法规及官方解释为准。

常见问题

《MDR》Article 107的原文是什么?
Conflict of interests 1.   Members of the MDCG, its sub-groups, and members of expert panels and expert laboratories shall not have financial or other interests in the medical device industry which could affect their impartiality. They shall undertake to act in the public interest and in an independent manner. They shall declare any direct or indirect interests they may have in the medical device
Article 107是什么意思?
该条主要规范涉及记录的留存与保管。具体理解应结合条文原文与上下文,并以官方解释与司法实践为准。
Article 107对 PDF 文档有什么影响?
落到文档上主要是:按留存期限建立台账并定期复核;版本另存,禁止覆盖原始记录;合并成套并连续编页便于检索。
条文引用以什么为准?
以官方最新有效文本为准。本页条文为官方发布文本的原文摘录,仅供参考,不构成法律意见。
处理相关文档要注意什么?
按最小必要裁剪,敏感字段做不可逆处理而非仅遮盖,处理另存副本并保留原始件。
遮盖敏感内容算处理到位吗?
通常不算。遮盖仅覆盖显示层,底层内容保留时可被还原,难以证明已采取充分措施。
批量文档怎么处理?
批量上传后统一套用规则一次性导出,处理前后各抽查一份确认效果。
本页能替代法律意见吗?
不能。本页仅供文档处理作一般性参考,具体适用请咨询具备资质的专业人士。

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