The Pipeline Gap: Why the EU AI Act, the Product Liability Directive and the Medical Device Regulation Do Not Reach Multi-Tool Clinical-AI Pipelines

<jats:p>Administrative artificial intelligence (AI) reaches primary care not as one tool but as a pipeline of interacting tools: scheduling, documentation, coding, billing, and referral, often with feedback loops between them. The regulatory timetable sharpens the question. Most of the EU AI Act applies from 2 August 2026, but the high-risk obligations that would reach clinical AI are deferred by the 2026 Digital Omnibus to 2 December 2027 for stand-alone Annex III systems and to 2 August 2028 for AI embedded in regulated products. An existing literature argues that the EU framework leaves gaps for medical AI. The contribution here is more specific: the gap sits at the level of the pipeline as a unit, and it is structural rather than incidental, because each principal instrument regulates a narrower unit. The AI Act regulates the individual system (Article 3(1)) and gates high-risk duties through Article 6 and Annex III, so most administrative clinical AI, being neither a device safety component nor an enumerated high-risk use, falls outside Articles 8 to 15. The recast Product Liability Directive (2024/2853) treats software as a product and considers interconnection, but still requires an identifiable defective product (Article 10(1)) and knows no correlated or systemic risk. The Medical Device Regulation gates on medical purpose (Article 2(1)), leaving administrative AI outside its scope. Four pipeline-level risks therefore fall between the three instruments: the pipeline as a regulated unit, cascade amplification, the ontological attack surface, and correlated systemic risk. We set out what a pipeline-level regime would require.</jats:p>