Amendment 131· Digital Omnibus proposal Recital 10a (new)

Addition

Tabled by: Aura Salla and 6 others (EPP)
Aura Salla, Niels Flemming Hansen, Ana Miguel Pedro, Andrea Wechsler, Eva Maydell, Oliver Schenk, Christian Ehler
Committee and document: ITRE–LIBE·amendments 79–250 to the draft report (CJ72-AM-786820, PE786.820v01-00)·27 July 2026
Source: Official text, p. 51·printed header: Recital 10 a (new)
Targets: Recital 10a (new) of the Digital Omnibus proposal

Text of the amendment

As tabled

Wording it would add

(10a)The data-access obligations set out in Chapter II should be voluntary for medical devices and in vitro diagnostic medical devices falling within the scope of Regulations (EU) 2017/745 and (EU) 2017/746, respectively, for electronic health record systems within the meaning of Regulation (EU) 2025/327, and for related services connected to such products, without prejudice to the application of sector-specific Union law.

Target

Wording of the targeted provisionlaw in force, Commission proposal, latest Council text

No Council text amends Recital 10a (new).

Cite this amendment

Amendment 131 (Aura Salla and others), European Parliament, Committee on Industry, Research and Energy and Committee on Civil Liberties, Justice and Home Affairs, amendments 79–250 to the draft report on COM(2025) 837 (CJ72-AM-786820, PE786.820v01-00, 27 July 2026), p. 51

Link, short form and official text

Link

https://research.eutechreg.com/trackers/digital-omnibus/amendments/itre-libe-131/

Reference

Short form

ITRE–LIBE Amendment 131 (CJ72-AM-786820), p. 51

Official text

CJ72-AM-786820, page 51

In the tracker

Amendment 131 on the Digital Omnibus proposal Recital 10a (new) page