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

Changes to notifications 通報的變更

Procedure when a notified body no longer meets requirements or ceases activities — restriction, suspension, withdrawal. 指定機構不再符合要件或停止活動時的程序,限制、暫停、撤銷。

Paragraphs段落數 · 4 Applies from適用起始 · 11 Jun 2026 Primary audience主要對象 · Notifying authorities · Notified bodies通報機關 · 指定機構 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 45 Changes to notifications 1. Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 39, or that it is failing to fulfil its obligations, the notifying authority shall restrict, suspend or withdraw notification as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly.

2. In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying Member State shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request.

第 45 條 通報之變更

1. 通報機關確認或被告知指定機構不再符合第 39 條要求或未履行其義務時、通報機關應視該不符合或未履行之嚴重程度、限制、暫停或撤回通報。應立即將此告知執委會及其他會員國。

2. 於限制、暫停或撤回通報之情形下、或指定機構停止活動時、通報之會員國應採取適當步驟、確保該機構之檔案由其他指定機構處理或在通報機關及市場監督機關請求時可取得。

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 45 alongside other regimes 第 45 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。