MedTech Europe views on the Artificial Intelligence Act

MedTech Europe, representing the voice of the medical technology industry, welcomes the opportunity to share its key messages on the European Commission’s proposed Artificial Intelligence Act (AI Act). While respecting existing laws on fundamental rights and Union values, the AI Act aims to ensure legal certainty to facilitate investment and innovation in AI, enhancing governance and safety requirements applicable to AI systems for trustworthy AI applications and preventing market fragmentation. Safe, high-quality and trustworthy AI in medical technologies can improve healthcare and patient outcomes. The medical technology industry welcomes AI regulation which supports accessibility of AI in medical technologies, and which provides a clear and innovation-friendly legal framework.

In order for the MDR/IVDR and the AI Act to work seamlessly together in practice, and thus enable the European medical technology industry to provide innovative solutions for patients and healthcare professionals and support the functioning of healthcare systems, the following key issues need to be addressed:

• Safe, high-quality and trustworthy AI: Patients’ access to AI-enabled medical technologies depends on their trust in AI and their willingness to embrace it in healthcare, which must be built on tailored safety, transparency and explainability requirements for medical technologies.
• Harmonisation and legal certainty: Creating a level playing field for all actors involved is crucial to improve health systems throughout Europe. Therefore, ensuring legal certainty and regulatory alignment is essential to overcome fragmentation between horizontal and sectoral regulations, such as the AI Act and the MDR/IVDR.
• Innovation: As healthcare is one of the most fast-paced sectors in developing new practices and approaches, AI in medical technology can bring an additional layer of agility and adaptability. It is paramount that the legal framework is seen as an opportunity to drive innovation by making rules more transparent and effective to strive for better patient outcomes.