European Commission Publishes Consolidated Version of the AI Act Incorporating Digital Omnibus Amendments
The European Commission has published an unofficial consolidated version of the Artificial Intelligence Act (AI Act)incorporating the amendments introduced through the Digital Omnibus package. The document integrates the adopted amendments into a single consolidated text, providing stakeholders with an updated reference for the application of the Regulation.
The consolidated version reflects how the AI Act interacts with existing Union harmonisation legislation, including the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), while maintaining the complementary application of sector-specific legislation for products incorporating artificial intelligence.
Interaction with Existing Union Harmonisation Legislation
The consolidated text reiterates that products incorporating high-risk AI systems may be subject to more than one piece of Union harmonisation legislation.
According to the Regulation, manufacturers placing products on the market must ensure compliance with both the AI Act and any applicable sector-specific legislation, including the MDR and IVDR, where relevant. The document also explains that the AI Act complements existing legislation by addressing risks that are specific to artificial intelligence.
Conformity Assessment and Harmonised Standards
The consolidated version maintains the framework for conformity assessment of high-risk AI systems and clarifies the role of harmonised standards in demonstrating compliance.
According to the Regulation, AI systems that comply with harmonised standards published in the Official Journal of the European Union benefit from a presumption of conformity with the applicable AI Act requirements. The document also provides for the development of common specifications where harmonised standards are not available.
Risk Management and Quality Management Systems
The Regulation continues to require providers of high-risk AI systems to implement risk management processes throughout the entire lifecycle of the AI system.
The consolidated text states that risk management should be a continuous and iterative process aimed at identifying, analysing and mitigating risks relating to health, safety and fundamental rights. It also confirms that providers subject to sector-specific quality management requirements may integrate the AI Act obligations into their existing quality management systems where appropriate.
Support for Innovation and Regulatory Implementation
The consolidated version also includes provisions intended to facilitate implementation of the AI Act, particularly for SMEs and innovation-focused organisations.
Among the measures described are:
Support through the AI-on-demand platform;
European Digital Innovation Hubs;
Testing and experimentation facilities;
Guidance for simplified quality management systems for microenterprises;
Continued development of harmonised standards and technical guidance.
Relevance for Medical Device and IVD Manufacturers
The publication is particularly relevant for manufacturers of medical devices and IVDs developing or placing on the market products incorporating artificial intelligence.
Topics of particular interest include:
Interaction between the AI Act, MDR and IVDR;
Conformity assessment of high-risk AI systems;
Harmonised standards and common specifications;
Integration of AI requirements into existing quality management systems;
Risk management throughout the AI system lifecycle;
Regulatory compliance for AI-enabled medical devices.
For manufacturers, the consolidated version provides an updated reference text that brings together the AI Act and the Digital Omnibus amendments, supporting a clearer understanding of the regulatory framework applicable to AI-enabled products within the European Union.
