Keyword Index

Relevant products: machinery, toys, recreational craft and personal watercraft, lifts and safety components for lifts, equipment and protective systems intended for use in potentially explosive atmospheres, radio equipment, pressure equipment, recreational craft equipment, cableway installations, personal protective equipment, appliances burning gaseous fuels, medical devices, and in vitro diagnostic medical devices, civil aviation, two- or three-wheel vehicles and quadricycles, agricultural and forestry vehicles, marine equipment, rail system.

Relevant areas: biometrics (remote biometric identification, biometric categorization, or emotion recognition systems), critical infrastructure (AI systems as safety components in the management and operation of critical digital infrastructure, road traffic, or in the supply of water, gas, heating or electricity), educational and vocational training (e.g. AI systems to determine access or admission or evaluate learning outcomes), employment (e.g. AI systems for the recruitment or selection of natural persons), essential private and public services and benefits (e.g. AI systems to evaluate the creditworthiness of natural persons or establish their credit score and for risk assessment and pricing in relation to natural persons in the case of life and health insurance), law enforcement, migration, asylum and border control management, administration of justice and democratic processes.

Some degree of independence of actions from human involvement and of capabilities to operate without human intervention (recital 12 AIA). 

The use of the AI system follows a previously completed human assessment which it is not meant to replace or influence, without proper human review. Such AI systems include for instance those that, given a certain grading pattern of a teacher, can be used to check ex post whether the teacher may have deviated from the grading pattern so as to flag potential inconsistencies or anomalies (recital 53 AIA).

An AI model, including when trained with a large amount of data using self-supervision at scale, that displays significant generality and is capable to competently perform a wide range of distinct tasks regardless of the way the model is placed on the market and that can be integrated into a variety of downstream systems or applications. This does not cover AI models that are used before release on the market for research, development and prototyping activities (Article 3 (63) AIA).

An AI system which is based on a general-purpose AI model, that has the capability to serve a variety of purposes, both for direct use as well as for integration in other AI systems (Article 3 (66) AIA).

Note: AI systems shall not cover systems that are based on the rules defined solely by natural persons to automatically execute operations.

Inference: Process of obtaining the outputs, such as predictions, content, recommendations, or decisions, which can influence physical and virtual environments and to a capability of AI systems to derive models and/or algorithms from inputs/data; the techniques that enable inference while building an AI system include machine learning approaches that learn from data how to achieve certain objectives, and logic- and knowledge-based approaches that infer from encoded knowledge or symbolic representation of the task to be solved. The capacity of an AI system to infer transcends basic data processing, enables learning, reasoning or modelling; AI systems shall not cover systems that are based on the rules defined solely by natural persons to automatically execute operations (recital 12 AIA).

AI systems run on machines (recital 12 AIA).

Any supply of an AI system or a general purpose AI model for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge (Article 3 (10) AIA).

Tasks of such narrow and limited nature that they pose only limited risks which are not increased through the use in a context listed in Annex III, such as AI systems that transform unstructured data into structured data, or that classify incoming documents into categories or that is used to detect duplicates among a large number of applications (recital 53 AIA).

For example, this criterion covers smart solutions for file handling, which include various functions from indexing, searching, text and speech processing or linking data to other data sources, or AI systems used for translation of initial documents (recital 53 AIA).

The first making available of an AI system or a general purpose AI model on the Union market (Article 3 (9) AIA); as of March 2024, it is not clear whether it depends under whose name or trademark the placement is done.

The AI system only provides an additional layer to a human activity with consequently lowered risk. For example, this criterion would apply to AI systems that are intended to improve the language used in previously drafted documents, for instance in relation to professional tone, academic style of language or by aligning text to a certain brand messaging (recital 53 AIA).

In short: Automated processing of personal data to evaluate certain personal aspects relating to a natural person (e.g. to analyse or predict the performance at work, economic situation, health, personal preferences, interests, reliability, behaviour, location or movements).

See Article 3 (52) AIA: Any form of automated processing of personal data as defined in point (4) of Article 4 of Regulation (EU) 2016/679; or in the case of law enforcement authorities – in point 4 of Article 3 of Directive (EU) 2016/680 or, in the case of Union institutions, bodies, offices or agencies, in point 5 Article 3 of Regulation (EU) 2018/1725.

The supply of an AI system for first use directly to the deployer or for own use in the Union for its intended purpose (Article 3 (11) AIA).

Different functions performed by AI systems and include predictions, content, recommendations or decisions that can influence physical or virtual environments (recital 12 AIA).

Component of a product or of a system which fulfils a safety function for that product or system, or the failure or malfunctioning of which endangers the health and safety of persons or property (Article 3 (14) AIA). In particular, such products are 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, medical devices, and in vitro diagnostic medical devices (recital 50 AIA).

A change to the AI system after its placing on the market or putting into service which is not foreseen or planned in the initial conformity assessment by the provider and as a result of which the compliance of the AI system with the requirements set out in Title III, Chapter 2 of this Regulation is affected or results in a modification to the intended purpose for which the AI system has been assessed (Article 3 (23) AIA).