The European Union has introduced comprehensive regulations for artificial intelligence (AI) systems, encapsulated in the EU AI Act (AI Act). The objective of the AI Act is to ensure that AI systems in the EU are safe, trustworthy, transparent, traceable, and non-discriminatory.
The AI Act is a horizontal legislation that governs the development, deployment, and use of AI systems within the EU, aiming to create a structured and consistent regulatory environment for AI systems. Notably, the AI Act is the first global regulation specifically targeting AI, setting a precedent for international AI governance.
In this article, we analyse the implications of the AI Act for the Medtech sector and highlight a number of key challenges for medical device manufacturers and their partners in aligning conformity routes for their products under the AI Act.
Background to the AI Act
Proposed by the European Commission in April 2021, the AI Act was approved by the European Parliament on 13 March 2024 and by the Council of the European Union on 21 May 2024, following multiple rounds of intense interinstitutional negotiations. On 12 July 2024, the European Union published the final text of the AI Act in the Official Journal of the EU (OJEU) (available here). The AI Act will enter into force 20 days after publication in the OJEU. It will become fully applicable two years thereafter, on 2 August 2026, save for some requirements that are subject to longer transitional periods.
Scope of the AI Act
The AI Act is designed to be industry-agnostic, applying across a wide range of sectors including healthcare, medical technology, financial services, and consumer products. It not only applies to EU-based entities, but also has an extraterritorial reach, impacting non-EU entities that market, deploy, or utilize AI systems or products incorporating AI in the EU. It also applies to a broad array of economic operators active in the AI supply chain, including providers, importers, distributors, and deployers of AI systems as well as AI product manufacturers.
Each of these economic operators in the supply chain will have responsibilities under the AI Act. Manufacturers of medical devices may become providers of AI systems under the AI Act. Should a medical device be subject to the AI Act, all partners within its supply chain will have to comply with new AI Act requirements.
Risk-based approach and timeline
The AI Act adopts a risk-based approach to AI regulation, categorizing systems into unacceptable, high, medium, and low-risk. Systems posing an unacceptable risk are banned, while those in the high, medium, and low-risk categories are subject to regulations of varying stringency, proportional to the risk they present. The obligations for economic operators differ according to the AI system’s risk level, aiming to strike a balance between the need for innovation and the imperative of protecting users from potential harms associated with AI.
Like many other products, medical technologies (including medical device software) may come under the scope of the AI Act.
AI-enabled medical devices could fall within the definition of high-risk AI system if the AI system is used as a safety component of a product1 or the AI system is itself a product, if it is covered under Union Harmonisation Law pursuant to Annex I to the AI Act (such as, the Medical Devices Regulation (MDR) and In Vitro Diagnostic medical devices Regulation (IVDR)) and if it is subject to a third party assessment under such Union Harmonisation Law.
In that case, the AI medical device will fall within the scope of the AI Act as well as the MDR or IVDR.
Continue reading…Timeline for the application of the AI Act to medical devices: 2 August 2027 / Conformity assessment / Recommendations
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