On 10 June 2026, the European Parliament published amendments tabled by the PFE political group to the Digital Omnibus on AI proposal, which would fundamentally restructure the regulation's scope. The amendments seek to remove the Machinery Directive, Toy Safety Directive, and Recreational Craft Directive from the simplification exercise and instead align the Omnibus with the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). This represents a direct challenge to the European Commission's original proposal, which aimed to simplify AI rules across a broad range of product safety legislation.
The three amendments (119-121) were submitted by the PFE group alone, with no other political groups tabling competing amendments. Amendment 119 deletes the original text covering the three product safety directives. Amendment 120 replaces that list with the MDR and IVDR, shifting the simplification's focus to the highly regulated medical technology sector. Amendment 121 re-introduces the three directives as separate standalone references, possibly as a fallback to ensure they remain subject to their own specific AI rules rather than being merged into the Omnibus.
Policy orientations and trade-offs PFE's amendments reflect a strategic preference for maintaining existing sector-specific safety standards for AI in health-related products, rather than applying a general simplification that could dilute requirements. The trade-off is clear: excluding machinery, toys, and recreational craft from the Omnibus would preserve their current regulatory rigor but would also deny those sectors the administrative simplification the Commission intended. The medical device sector, already governed by the MDR and IVDR, would gain explicit alignment with the Omnibus, potentially streamlining AI compliance for health-tech products but also adding complexity for manufacturers operating across multiple product categories.
Impact on stakeholders - Medical device manufacturers: Positive impact, moderate. Explicit reference to MDR and IVDR provides regulatory clarity and potential simplification for AI systems used in diagnostics and therapeutic devices, reducing uncertainty about overlapping rules. - Machinery, toy, and recreational craft manufacturers: Negative impact, moderate. Exclusion from the Omnibus means they remain subject to existing sectoral directives without the intended simplification, potentially facing higher compliance costs and fragmented AI rules. - EU regulatory bodies: Mixed impact. Shifting scope to medical devices may reduce the administrative burden of coordinating across multiple product safety directives but could increase complexity in overseeing AI in health products, which already have stringent oversight. - Consumers and patients: Positive impact, moderate. Maintaining rigorous safety standards for AI in medical devices protects patient safety, while the exclusion of toys and machinery may preserve existing protections for children and workers.
Expected institutional follow-up The amendments will be considered by the European Parliament's lead committee (likely IMCO or JURI) before a plenary vote. The Council must then adopt its position, potentially leading to trilogue negotiations. The Commission's original proposal aimed for rapid simplification, but PFE's amendments signal a push for a more cautious, sector-specific approach. The outcome will depend on whether other political groups support the shift or advocate for the original broader scope.
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