CN CRA NotebookCRA 閱讀筆記
Working note — actively evolving, may be revised. See /errata for change log. 推進中的筆記,可能持續修改。修訂紀錄見 /errata

Article 46 Regulation (EU) 2024/2847 · Chapter IV 法規 (EU) 2024/2847 · 第四章

Challenge of the competence of notified bodies 對指定機構能力的質疑

Commission investigates cases where the competence of a notified body is doubted, with corrective measures. 當指定機構能力受質疑時、執委會進行調查並採取矯正措施。

Paragraphs段落數 · 2 Applies from適用起始 · 11 Jun 2026 Primary audience主要對象 · Commission執委會 Last reviewed最後校閱 · 2026-04-26 Status狀態 · Working書寫

Block 1 · Official text 區塊 1 · 官方條文

What the Regulation actually says 條文實際怎麼寫

Source. From Regulation (EU) 2024/2847, OJ L 2024/2847 (20 Nov 2024). Translation unofficial; refer to EUR-Lex for binding text. 來源。節錄自《法規 (EU) 2024/2847》,OJ L 2024/2847(2024 年 11 月 20 日)。中文為非官方翻譯;強制適用條文請見 EUR-Lex

Article 46 Challenge of the competence of notified bodies 1. The Commission shall investigate all cases where it doubts, or where doubt is brought to its attention regarding, the competence of a notified body to meet, or the continued fulfilment by a notified body of, the requirements and responsibilities to which it is subject.

2. The notifying Member State shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the body concerned.

3. The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially.

4. Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including de-notification if necessary.

第 46 條 對指定機構能力之質疑

1. 執委會應調查所有對指定機構之能力或其持續履行所交付要求與責任有所懷疑或經提請其注意之案件。

2. 通報之會員國應於請求時向執委會提供相關通報之依據或所涉指定機構能力維持之相關全部資訊。

3. 執委會應確保調查過程中所獲得之全部敏感資訊、皆受機密處理。

4. 執委會確認指定機構不符合或不再符合通報之要求時、應通過實施法律行為要求通報之會員國採取必要之矯正措施、必要時包括撤回通報。

Block 2 · Plain language 區塊 2 · 白話解讀

What this actually means 這其實在說什麼

Reading in progress 閱讀中

Not yet drafted. The Official text in Block 1 above is the binding reference for now. 尚未撰寫。目前以上方區塊 1 的官方條文為準。

Block 3 · APAC perspective 區塊 3 · APAC 觀點

How this lands in Taiwan, Japan, Korea 這一條在台日韓怎麼落地

Reading in progress 閱讀中

Not yet drafted. The Official text in Block 1 above is the binding reference for now. 尚未撰寫。目前以上方區塊 1 的官方條文為準。

Block 4 · Cross-regulation map 區塊 4 · 跨法規對照

Article 46 alongside other regimes 第 46 條與其他法規的對照

Reading in progress 閱讀中

Not yet drafted. The Official text in Block 1 above is the binding reference for now. 尚未撰寫。目前以上方區塊 1 的官方條文為準。