Teatis - COVER NOTE From: The Italian 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 - 2025/0404(COD)] - Opinion on the application of the Principles of Subsidiarity and Proportionality - SWD(2025) 1050-1052, COM(2025) 1023

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Toimik	Ettepanek: EUROOPA PARLAMENDI JA NÕUKOGU MÄÄRUS, millega muudetakse määrusi (EL) 2017/745 ja (EL) 2017/746 seoses meditsiiniseadmeid ja in vitro diagnostikameditsiiniseadmeid käsitlevate eeskirjade lihtsustamisega ja neist tuleneva koormuse vähendamisega, määrust (EL) 2022/123 seoses Euroopa Ravimiameti toega meditsiiniseadmete eksperdirühmadele ja määrust (EL) 2024/1689 seoses I lisas osutatud liidu ühtlustamisõigusaktide loeteluga (EMPs kohaldatav tekst) - SWD(2025) 1050-1052, COM(2025) 1023
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Failid

st10876.xx26.pdf

10876/26

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Council of the European Union

Brussels, 19 June 2026 (OR. en, it)

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SAN 503 PHARM 114 MI 678 COMPET 807 CODEC 1267 INST 260 PARLNAT 134

PARLNAT

Interinstitutional File: 2025/0404 (COD)

COVER NOTE

From: The Italian Senate

date of receipt: 18 June 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 - 2025/0404(COD)]

- Opinion on the application of the Principles of Subsidiarity and Proportionality

Delegations will find attached the opinion1 of the Italian 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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