The European Union has published the finalized text of the Artificial Intelligence Act (AIA) which is a significant step forward in regulating the use of artificial intelligence (AI) in medical devices, aiming to ensure safety, efficacy, and ethical standards. According to the European Parliament, it is the first comprehensive AI law in the world, and it sets harmonized rules for placing products on the market.
Artificial Intelligence refers to the simulation of human intelligence processes by machines, especially computer systems. In medical devices, AI can perform tasks such as diagnosing diseases, predicting patient outcomes, and personalizing treatment plans.
Artificial Intelligence Act (AIA) finalized by the European Commission, establishes a legal framework that promotes the adoption of this Regulation, namely to improve the functioning of the internal market and to encourage the uptake of human-centric and trustworthy AI, while ensuring a high level of protection of health, safety, fundamental rights using medical devices, in vitro diagnostics (IVDs) and other products.
On 12 July, the AIA was published in the Official Journal and the ACT will become effective on 2 August, while the requirements for high-risk devices will become effective one year later, on 2 August 2026. The text is unchanged from the AI Act approved by the European Parliament on 13 March.
AI medical devices are classified based on their risk to patients and users. Higher-risk devices are subject to more stringent regulatory oversight. Manufacturers must conduct thorough risk assessments and implement robust risk management processes to mitigate potential hazards associated with AI technologies.
The regulation mandates transparency in AI algorithms used in medical devices. This includes clear documentation of how the AI functions and makes decisions. Manufacturers must also establish accountability mechanisms to address any adverse events or failures. This transparency is crucial for building trust among healthcare professionals and patients.
The regulation also emphasizes the need for continuous monitoring to address any ethical concerns that may arise during the device's lifecycle.Manufacturers are required to establish a robust post-market surveillance system. This involves continuous monitoring of AI medical devices in the market to ensure they perform as intended and to quickly address any safety or performance issues.
Manufacturers are required to establish a robust post-market surveillance system. This involves continuous monitoring of AI medical devices in the market to ensure they perform as intended and to address any safety or performance issues quickly. AI medical devices must undergo a conformity assessment to verify they meet regulatory requirements.
The new regulation presents both challenges and opportunities for manufacturers of AI medical devices. Complying with the EU regulation is crucial for gaining market access. Non-compliance can result in significant delays, penalties, and even bans on the sale of non-compliant devices within the EU.
The new EU regulation governing the use of AI in medical devices marks a significant milestone in the medical device industry. For more detailed information, refer to the full EU AI Act here.
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