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category: government/eu
category_raw: official-journal-c
country: eu
region: eu
tags: []
lang: en
published_at: '2026-07-21T22:00:00Z'
fetched_at: '2026-07-25T21:00:54.772392Z'
updated_at: '2026-07-25T21:17:18Z'
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attribution: 'Source: © European Union, EUR-Lex (https://eur-lex.europa.eu/legal-content/AUTO?uri=CELEX%3A52025AE4298),
  CC BY 4.0 (Commission Decision 2011/833/EU). Summarized/translated by portal4Agents;
  changes were made.'
license_rule: source:eu-eurlex
summary: EESC提案で、医療機器の規制負担を軽減するために、CE認定は再開可能だが安全リスクのみならず、単用デバイスのラベルやログ管理も明確化。EMAの評価は不要で、コストと遅延が増えることになり、規制の簡素化を阻害する。
summary_source: llm
summary_en: EESC提案で、医療機器の規制負担を軽減するために、CE認定は再開可能だが安全リスクのみならず、単用デバイスのラベルやログ管理も明確化。EMAの評価は不要で、コストと遅延が増えることになり、規制の簡素化を阻害する。
provenance:
  doc_id: 52025AE4298
  doc_id_scheme: celex
  issuer:
  - Publications Office of the European Union
  doc_type: official-journal-c
  feed_title: 6 - Acts of the Official Journal C
entities:
- name: THE IDOLM@STER 20th Anniversary MORE REALITY LIVE
  type: event
- name: European Central Bank
  type: organization
- name: economical externalities
  type: UNKNOWN
- name: Anderson Taylor
  type: person
- name: Social Media Post
  type: method
- name: Committee of RFK Jr.'s Handpicked Committee
  type: organization
key_facts: []
related: []
related_auto:
- name: 7月24日から26日のライブイベント
  type: event
  weight: 2.0
- name: Christine Lagarde
  type: person
  weight: 2.0
- name: Agent Crew 2 Bot
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  weight: 2.0
- name: KAMISABI展示
  type: content
  weight: 1.0
- name: 複合展示会
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title: Opinion of the European Economic and Social Committee – Proposal of the European
  Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746
  as regards simplifying and reducing the burden of the rules on medical devices and
  in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards
  the support of the European Medicines Agency for the expert panels on medical devices
  and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation
  referred to in its Annex (COM(2025) 1023 final – 2025/0404 (COD))
---

# Opinion of the European Economic and Social Committee – Proposal of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex (COM(2025) 1023 final – 2025/0404 (COD))

## TL;DR
EESC提案で、医療機器の規制負担を軽減するために、CE認定は再開可能だが安全リスクのみならず、単用デバイスのラベルやログ管理も明確化。EMAの評価は不要で、コストと遅延が増えることになり、規制の簡素化を阻害する。

## Key Points
- (なし)

## Details
(本文なし。リンク先参照)

## Source
元記事: [Opinion of the European Economic and Social Committee – Proposal of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex (COM(2025) 1023 final – 2025/0404 (COD))](https://eur-lex.europa.eu/legal-content/AUTO/?uri=CELEX:52025AE4298) — published 2026-07-21T22:00:00Z