DigitalEurope hails AI Omnibus machinery fix but says medtech excluded

DigitalEurope welcomed the AI Omnibus moving machinery to Annex I Section B, avoiding duplicate AI Act checks and saving SMEs about EUR 600,000 in year one costs, but said the deal excludes medical devices, leaving medtech under overlapping AI Act and MDR rules.

Verified Opinion AI-drafted DigitalEurope press statement, 7 May 2026

What the source does not establish. This records DigitalEurope's own reaction; it does not itself amend the AI Act or the Omnibus text working through the legislature.

Index score. No movement: no answer to who owns, who operates, whose law governs or who made the parts changes. Weight 0. none: an association's reaction to an EU-wide rule change, not itself law. European Sovereignty Index

How this item was made. Drafted by an AI system (Claude (Anthropic)) from the source cited above and published under the editor’s responsibility without a person reading it first. How the record is made

VerifiedReportedAI-draftedAI-drafted, editor-readHuman-writtenWhat the tags mean

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