EU publishes regulation governing use of AI in medical devices and IVDs

The European Commission has published the finalized text of the Artificial Intelligence Act (AIA) which establishes a legal framework to promote the uptake of “human centric and trustworthy” AI for medical devices, in vitro diagnostic devices (IVDs) and other products. The Act also sets harmonized rules for placing products on the market, and is the world’s first comprehensive AI law, according to the European Parliament.

The AIA was published in the Official Journal on 12 July and will go into effect on 2 August, while the requirements for high-risk devices will go into effect one year later, on 2 August 2026. The text is unchanged from the AI Act adopted by the European Parliament on 13 March.

The Act aims to improve the functioning of the internal market, prohibits certain AI practices and adds specific requirements for high-risk AI systems. It does not apply to research or testing activities prior to placing products on the market. The regulation also mandates that providers and deployers of AI systems provide a “sufficient level” of AI literacy to their staff.

Devices are deemed a high risk if they are placed in the Class IIa category or higher under the Medical Devices Regulations. The regulation specifies that manufacturers of high-risk devices will have to establish a risk management system throughout the product’s lifecycle, conduct data governance to attest that data is free from errors and provide technical documentation attesting that their products comply with the Act. Manufacturers of these products will have to provide instructions for use and establish a quality management system to ensure compliance.

The regulation further specifies that high-risk systems should be designed and developed in such a way as to ensure that their operation is transparent and can enable deployers to interpret a system’s output. These systems should also be accompanied by instructions for use that provide information that is “concise, complete, correct and clear” to deployers.

The regulation also establishes other categories for those devices posing a more limited risk and manufacturers of these products are not subject to the more stringent requirements of the higher risk category.

According to a recent blog post from the consultancy IQVIA, a large segment of AI’s use in healthcare would be classified as ‘high-risk’ under the Act and thus subject to multiple requirements.

At RAPS Euro Convergence meeting in Berlin earlier this year, European regulators and health authorities sought to provide assurance that AIA is compatible with the Medical Device Regulation (MDR) (RELATED: Euro Convergence: Regulators discuss device availability, AI Act, lessons from pharma. Regulatory Focus 8 May 2024).

These assurances were prompted by concerns expressed by MedTech Europe earlier this year that AIA would conflict Medical Device Regulations and the In Vitro Diagnostic Directive.

Besides medical devices and IVDs, the scope of the Act covers machinery, toys, lifts, equipment and protective systems intended for use in potentially explosive atmospheres, radio equipment, pressure equipment, recreational craft equipment, cableway installations, appliances burning gaseous fuels, automotive and aviation products.

EU AI Act

EU publishes regulation governing use of AI in medical devices and IVDs

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