Digital Omnibus proposal
Recital 10a
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Recital total: 1 part · 0 Council drafts · 1 Parliament amendment
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Additional proposed wording Amendment 131 · Aura Salla, Niels Flemming Hansen, Ana Miguel Pedro, Andrea Wechsler, Eva Maydell, Oliver Schenk, Christian Ehler ITRE · LIBE
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.
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