Section 1: Definitions and scope of application

A medical biology examination is a medical procedure which contributes to the prevention, screening, diagnosis or assessment of the risk of the occurrence of pathological conditions, to therapeutic decision-making and management, or to the determination or monitoring of the physiological or pathophysiological state of the human being, with the exception of pathological anatomy and cytology procedures performed by doctors specialising in this field. By way of derogation from the first…

A medical biology examination takes place in three phases: 1° The pre-analytical phase, which includes taking a biological sample from a human being, collecting the relevant clinical elements, preparing, transporting and storing the biological sample until it reaches the place where it is analysed; 2° The analytical phase, which is the technical process used to obtain a biological analysis result; 3° The post-analytical phase, which includes validation, contextual interpretation of…

Tests, the collection and processing of biological signals for the purposes of screening, diagnostic orientation or immediate therapeutic adaptation do not constitute a medical biology examination. The health professionals or certain categories of persons listed by a decree of the Minister for Health may carry out the tests, collections and processing of biological signals set by a decree published annually after consulting the committee referred to in Article L. 6213-12…

Screening for transmissible infectious diseases by means of a rapid diagnostic test may be carried out on a minor by staff from the structures mentioned in the third paragraph of article L. 6211-3. Notwithstanding article 371-1 of the Civil Code , the staff mentioned in the first paragraph of this article may dispense with obtaining the consent of the holder(s) of parental authority when this screening is necessary to safeguard…

In the départements mentioned in article L. 3114-5, the provisions of this book do not apply to examinations carried out in places far from any medical biology laboratory with a view to diagnosing and treating some of the diseases mentioned in the same article, which are likely to represent a vital risk in the short term. These examinations, the list of which is set by decree, are carried out by…

A medical biology examination carried out with a view to establishing a prenatal diagnosis is subject to the provisions of this book and those of Chapter I of Title III of Book I of Part Two.

A medical biology examination relating to the genetic characteristics of a person or their identification by genetic fingerprinting is subject to the provisions of this Book and those of Chapter I of Title III of Book I of Part One.

The provisions of Title I and Title II of this Book are applicable to medical biology laboratories under the authority of the Minister for Defence, subject to the provisions of Chapter IV of Title I and Chapter IV of Title II.