Teatis - COVER NOTE From: The French Senate Subject: Proposal for a REGULATION 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 I [16919/25 - COM(2025) 0404 final] - Reasoned opinion on the application of the Principles of Subsidiarity and Proportionality - COM(2025) 0404

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Toimik	Teatis - COVER NOTE From: The French Senate Subject: Proposal for a REGULATION 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 I [16919/25 - COM(2025) 0404 final] - Reasoned opinion on the application of the Principles of Subsidiarity and Proportionality - COM(2025) 0404
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st09417.xx26.pdf

9417/26

LIFE.5 EN/FR

Council of the European Union

Brussels, 19 May 2026 (OR. en, fr)

9417/26

SAN 312 PHARM 88 MI 494 COMPET 582 CODEC 944 INST 228 PARLNAT 124

PARLNAT

Interinstitutional File: 2025/0404 (COD)

COVER NOTE

From: The French Senate

date of receipt: 13 May 2026

To: The President of the Council of the European Union

Subject: Proposal for a REGULATION 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 I [16919/25 - COM(2025) 0404 final]

- Reasoned opinion on the application of the Principles of Subsidiarity and Proportionality

Delegations will find enclosed the opinion1 of the French Senate on the above.

1 The translation(s) of the opinion may be available on the Interparliamentary EU Information Exchange website

(IPEX) at the following address: https://secure.ipex.eu/IPEXL-WEB/document/COM-2025-1023

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ANNEX

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