The landmark AI Act, its ripple effects on the medical technology industry and the challenges yet to be tackled

As we witness the AI Act entering into force, MedTech Europe applauds the European Commission and the co-legislators for taking a leading role in this momentous endeavour. The AI Act represents the first supranational framework aimed at regulating the safety and quality aspects of AI applications across sectors and domains. While it is a landmark law, it brings certain challenges in terms of implementation. Nevertheless, we are ready to collaborate closely with regulators to address the remaining concerns faced by the medical technology sector.

Clarity and Consistency in AI Regulation

AI in medical technologies is not unregulated, rather, AI-enabled medical technologies are regulated as software under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). Many of them will now also fall under the AI Act, requiring compliance with both sets of regulations. We welcome the AI Act's emphasis on consistency and reducing administrative complexities stemming from the simultaneous application of different legislation. As such, we are ready to engage with regulators to ensure that the AI Act represents complementary legislation to the MDR and IVDR without duplicating or conflicting with existing procedures.

A Single Conformity Assessment

The AI Act needs to be futureproof, fostering a smooth conformity assessment process for AI-enabled medical technologies. To do so, the conformity assessment under the AI Act should align with the corresponding MDR/IVDR provisions. The work of notifying authorities and notified bodies can be facilitated by maintaining existing technology codes under MDR/IVDR, assisting sectoral notified bodies with the designation procedures under the AI Act, and avoiding unnecessary designation delays.

Facilitate Clinical and Performance Evaluations of AI-Medical Technologies

Clinical investigations and performance studies are an MDR/IVDR bedrock, helping manufacturers bring effective life-saving technologies to patients. They also underpin the much-needed trust in medical technology safety and performance. The AI Act should facilitate rather than detract in this regard. We would welcome a specific priority clause being established whereby MDR/IVDR prevail in cases of conflict. We specifically call for definitive clarification that clinical and performance evaluations are exempt from any CE-marking requirements of the AI Act, and thus, follow the established MDR/IVDR logic of pre-market testing.

Next Steps

Medical technology innovators are already making scientific breakthroughs on the daily with the help of advanced AI tools. The development of novel digital health solutions with the help of AI models and the application of data collected and analysed by AI has now become commonplace. AI-enhanced diagnostic solutions can help prevent hospitalisations, save countless lives and significantly reduce EU public health costs. We strive to support these endeavours, and swiftly deliver secure, life-saving technologies for the benefit of patients across Europe.

MedTech Europe looks forward to supporting regulators in developing robust implementation guidelines, aimed at providing the necessary clarity, guarantee alignment with existing legislation, and streamline administrative and operational requirements.