Discover how the EU AI Act will impact hospitals and patients by 2027. Tucuvi explains key deadlines, safety requirements, and benefits for healthcare and clinical AI adoption.
In August 2027, AI-based medical solutions regulated as medical devices under the MDR will be required to fully comply with safety, traceability, and human oversight requirements.
With less than a year to go before the AI Act applies to high-risk artificial intelligence systems, hospitals, patients, and technology providers are preparing for an unprecedented regulatory shift. The progressive implementation of the regulation will begin on August 2, 2026, and one year later, in August 2027, medical solutions regulated as medical devices under the MDR will need to fully meet the requirements of safety, traceability, and human oversight.
In this context, Tucuvi, an international health technology company pioneering certified voice-based AI, analyzes the implications of the new regulatory framework. The company, which this year became the first clinical voice AI certified as a Class IIb medical device under the European Medical Device Regulation (MDR), highlights five key insights to help hospitals and patients understand its scope and prepare for its implementation.
What changes and when? The timeline shaping healthcare adaptation
Since February 2, 2025, the first bans on “unacceptable risk” uses, such as subliminal manipulation or social scoring, have been in force, along with the requirement for AI literacy programs for professionals. August 2, 2026, will mark a milestone for multiple high-risk systems; and in healthcare, medical solutions regulated as medical devices (MDR/IVDR) will have to fully comply with new requirements for safety, traceability, human oversight, and transparency starting August 2, 2027.
Healthcare under the “high-risk” category
The AI Act classifies as high-risk all AI systems used in clinical environments, from clinical decision-support tools to components of medical products. This entails reinforced controls in risk management, data governance, quality, and human supervision. It also requires continuous post-market monitoring systems to ensure the long-term safety and reliability of these solutions.
How the AI Act and MDR complement each other
The new European AI Regulation does not replace the MDR, it complements it by strengthening both technological and clinical aspects. Both frameworks share requirements for quality, risk management, and technical documentation, enabling synergies in certification and audit processes. This means providers already holding CE marking under MDR have a competitive advantage, while those without it will face a more demanding regulatory adaptation process.
Innovation built on solid principles
The healthcare system now has an opportunity to strengthen trust in emerging technologies. Beyond regulating the market, the AI Act promotes a future vision where technological innovation is built on solid foundations, especially when applied to people’s health. This will help prioritize solutions with regulatory evidence, reducing risks and improving care experiences.
Expected benefits for patients
The new regulation places patients at the center by requiring precision and traceability standards for AI-based healthcare solutions. These measures help reinforce user trust and ensure that technologies used in their care meet appropriate levels of accuracy, robustness, and human oversight. As a result, the AI Act contributes to a more transparent, safe, and human-centered healthcare system—where innovation serves both health and patient protection.
The application of this new framework is not merely a regulatory requirement, but a mechanism to ensure that the adoption of artificial intelligence in healthcare occurs with guarantees for patients, professionals, and institutions. Operating within a regulated and evidence-based environment strengthens system trust, reduces risk, and enables responsible and scalable implementation,” says María González, co-founder and CEO of Tucuvi.
