The EU AI Act’s Machinery Exemption: Does It Extend to Surgical Robotics?

The EU’s latest AI reforms are intended to reduce regulatory duplication for products already subject to extensive sector-specific regulation. For manufacturers of surgical robotics, however, they leave unresolved how AI embedded within increasingly sophisticated surgical systems will be regulated in practice.

Why Did Machinery Receive an Exemption?

Recent reforms to the EU AI Act have focused on reducing regulatory duplication for products already subject to extensive sector-specific regulation. Under the proposed “AI Omnibus” changes, certain AI systems embedded in machinery would be regulated primarily through existing product-safety legislation rather than through a separate layer of AI-specific requirements.

The central objective of the reform is to reduce regulatory duplication. AI systems covered by the Machinery Regulation (EU) 2023/1230 should be regulated primarily through that machinery framework, which already address safety risks. This was achieved by moving machinery from Annex I, Section A to Annex I, Section B of the AI Act, thereby reducing overlap between sector-specific product safety requirements and the AI Act’s standalone high-risk obligations.

Importantly, however, policymakers have not extended this carve-out to medical devices. AI-enabled medical devices therefore remain listed in the high-risk framework under Annex I, Section A of the AI Act. This distinction has triggered discussion within the MedTech sector, with industry organisations questioning why products already subject to extensive MDR and IVDR requirements should not benefit from a similar simplification approach.

Surgical Robotic Systems at the Intersection of Two Regulatory Regimes

Surgical robotic ecosystems are hybrid: they may combine machinery and medical device functions. AI used for robotic arm movement, collision avoidance, force limitation or mechanical safety functions may arguably belong to the machinery layer. By contrast, AI used for image analysis, tissue recognition, surgical navigation, treatment recommendations, or clinical decision support is much more likely to be considered part of the medical device function.

In other words, a surgical robot is unlikely to benefit from a blanket exemption from the AI Act simply because it contains machinery. The more relevant question is whether specific AI functionalities within a surgical robotics platform—or the broader ecosystem of connected technologies surrounding it—can be assessed differently depending on their purpose and regulatory classification. Manufacturers may therefore need to assess AI functionalities individually and potentially navigate different conformity-assessment pathways across a single surgical ecosystem.

The Classification Challenge Across the Surgical Robotics Ecosystem

Modern surgical robotics platforms increasingly rely on AI-enabled imaging systems, navigation software, digital surgical planning tools, sensors, cloud-based analytics, workflow optimization software, and other connected technologies.

Some of these products may qualify as accessories to a medical device under the EU Medical Device Regulation (MDR). Others may constitute medical devices in their own right, particularly where they analyze patient data or generate information used for diagnosis or treatment decisions.

As a result, a single surgical robotics ecosystem may contain:

• machinery-related AI functions,
• AI-enabled medical devices,
• AI-enabled accessories,
• standalone medical-device software, and
• third-party AI components integrated into the platform.

Each may be subject to different regulatory obligations under the AI Act, MDR, and other sector-specific legislation.

The classification exercise therefore becomes far more than a technical assessment. It becomes a strategic compliance decision with direct implications for conformity assessment, technical documentation, post-market monitoring, and product development.

The AI Omnibus therefore appears to raise as many questions as it answers for robotics manufacturers. Although the proposed framework seeks to reduce duplication by relying on sector-specific legislation, the Commission may introduce additional AI-related health and safety requirements through delegated acts under the Machinery Regulation. While this approach is intended to avoid overlap between the AI Act and existing product-safety frameworks, there is currently little guidance on how it will operate in practice, particularly for products that sit at the intersection of machinery and medical-device regulation.

What Relief Does the AI Omnibus Provide?

Although medical devices were not included in the carve-out, the Omnibus offers several practical benefits.

Most notably, the compliance timeline for Annex I high-risk systems embedded in regulated products has been extended until August 2, 2028. For manufacturers of complex surgical robotics platforms, this additional time may prove particularly valuable given the continuing uncertainty surrounding the classification of AI functionalities within hybrid products.

In addition, manufacturers are expected to benefit from greater flexibility for real-world testing of high-risk AI systems before market placement.

Liability Risks in an Increasingly Autonomous Ecosystem

The revised Product Liability Directive (Directive (EU) 2024/2853), applicable from December 2026, expressly recognizes software as a product. As EU Member State law implements the Directive, an AI component of a surgical robotic system may itself become the subject of a strict liability claim, irrespective of compliance with MDR or the AI Act.

As surgical platforms become increasingly autonomous and incorporate third-party AI technologies, manufacturers should carefully review contractual risk allocation, supplier oversight arrangements, and insurance coverage.

The Road Ahead for Surgical Robotics Manufacturers

The AI Omnibus has not resolved the regulatory position of surgical robotics. Instead, it has sharpened a fundamental question: where does machinery AI end and medical-device AI begin?

Until regulators provide further guidance, manufacturers should assume that clinically relevant AI functionalities—including imaging analysis, navigation, decision support, and other patient-facing applications—remain subject to the AI Act’s high-risk requirements. Manufacturers should continue to monitor MDCG and national authority guidance, and should carefully review contractual risk allocation, supplier oversight arrangements, and insurance coverage.

This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.