Compliance

Intended Purpose

The use for which an AI system is intended by the provider, as specified in documentation and instructions.

How the laws define this

Both regulatory texts establish that an intended purpose centers on the specific use intended for a system or software, serving as a decisive factor in determining risk classification and applicable regulatory oversight. The primary divergence lies in how each source specifies what constitutes this purpose and where it must be evidenced. Under the MHRA guidance: Software and AI as a Medical Device (updated guidance), the concept explicitly encompasses target populations and clinical claims, acting as the primary driver for risk assessment, device classification, and applicable regulatory obligations. In contrast, the Draft Commission Guidelines on the Classification of High-Risk AI Systems under the EU AI Act focus on the provider's intent as indicated through specific materials, namely technical documentation, instructions for use, or promotional materials, to evaluate whether an AI system falls under a high-risk classification.

Synthesised from the 2 statutory definitions below. Each one is quoted in full, with its source.

What it triggers

In the Draft Commission Guidelines on the Classification of High-Risk AI Systems under the EU AI Act, it is a crucial factor in determining whether an AI system falls under the high-risk classification.source

Definitions (2)

The specific use(s), target population, and clinical claims for which the software is intended; this statement is the primary determinant of device classification, risk assessment, and applicable regulatory obligations.

MHRA guidance: Software and AI as a Medical Device (updated guidance)Definition 1 of 2

The 'intended purpose' refers to the use for which an AI system is intended by the provider, as indicated in technical documentation, instructions for use, or promotional materials. It is a crucial factor in determining whether an AI system falls under the high-risk classification.

Draft Commission Guidelines on the Classification of High-Risk AI Systems under the EU AI ActDefinition 2 of 2

Not to be confused with

High-Risk AI System

Intended purpose determines classification into high-risk AI systems, while high-risk AI system refers to those already classified as posing significant risks to health, safety, or fundamental rights.

Technical Documentation

Intended purpose is indicated in technical documentation among other sources, whereas technical documentation consists of detailed records demonstrating compliance with regulatory requirements.

Questions and answers

How does intended purpose affect high-risk classification under EU AI Act guidelines?

The draft guidelines state it refers to the use indicated in technical documentation, instructions, or promotional materials. It serves as a crucial factor in deciding high-risk classification.

Where is the intended purpose of an AI system specified?

MHRA guidance implies it in documentation for medical devices. EU draft guidelines specify technical documentation, instructions for use, or promotional materials.