The Artificial Intelligence (AI) Act entered into force on 1 August 2024 in the European Union. A world first in terms of comprehensive AI law, this new regulatory framework is designed to foster responsible development of products using AI technologies. This in turn is intended to enhance the transparency and trustworthiness of AI.
Under the new framework, AI development is required to respect fundamental rights of people and businesses, safety and ethical principles. The act aims to harness the many benefits that AI has to offer, whilst simultaneously prohibiting unsafe AI.
The AI Act is applicable across all industries involved in AI development and deployment, including the medical device industry. AI is considered to have the potential to transform healthcare, and the AI Act is intended to be applied alongside Regulation (EU) 2017/745 on medical devices (MDR) and Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) for ensuring optimal safety of AI-powered medical devices.
AI systems are classified according to the risk they pose to users, and the level of regulation required depends on the level of risk. The risk levels are:
– Unacceptable risk. Systems falling under this category are banned.
– High risk. AI systems developed for a wide variety of professional applications, including certain AI-driven medical devices, are classed as high risk.
– Limited risk. This refers to the risks associated with lack of transparency in AI usage.
– Minimal or no risk. The vast majority of AI systems currently in use in the EU fall under this category. The AI Act allows free use of these low-risk or no-risk systems.
The AI Act will be fully applicable 2 years after the entry into force date, although there are exceptions for which the transition period is as short as 6 months (systems with an unacceptable risk) or as long as 36 months (high-risk systems).
Under the AI Act, AI systems require conformity assessment before they are put into service or placed on the market. While there are similarities with the corresponding procedures in the MDR and IVDR, conformity assessment under the AI Act is a separate procedure necessitating the intervention of a suitably designated notified body.
If you have questions on the impact of the EU AI Act on your medical device or in vitro diagnostic medical device, please feel free to contact us via our Contact page.