# Informed consent

> Applicable under EU regulations for real-world testing.

- Article: Art. 3(59)

## Introduction

Definition of informed consent in the context of real-world testing.

## Content

a subject’s freely given, specific, unambiguous and voluntary expression of his or her willingness to participate in a particular testing in real-world conditions, after having been informed of all aspects of the testing that are relevant to the subject’s decision to participate;

## Official source
- [Source](https://eur-lex.europa.eu/legal-content/FR/TXT/?uri=CELEX:32024R1689#art_3)