Chapter I: Legal status of medical devices.

Articles in this section · 8

L5211-1L5211-2L5211-3L5211-3-1L5211-3-2L5211-5L5211-5-1L5211-6

Article L5211-1

French Public Health CodeIn force
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Updated 6 Nov 2023

I.-The placing on the market, putting into service and making available on the market of medical devices and their accessories shall comply with the provisions of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 and with the provisions of this Title.

These provisions shall also apply to the groups of products not intended for medical use listed in Annex XVI to the same Regulation.

II.-Medical device means: any instrument, apparatus, equipment, software, implant, reagent, material or other article, intended by the manufacturer to be used, alone or in combination, in human beings for one or more of the medical purposes mentioned below and whose principal intended action in or on the human body is not obtained by pharmacological or immunological means or by metabolism, but whose function may be assisted by such means:

1° Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease;

2° Diagnosis, control, treatment, alleviation of or compensation for an injury or disability;

3° Investigation, replacement or modification of an anatomical structure or function or a physiological or pathological process or state;

4° Communication of information by means of in vitro examination of samples from the human body, including organ, blood and tissue donations.

The following are deemed to be medical devices

-devices intended to control or assist design;

-products specifically intended for the cleaning, disinfection or sterilisation of medical devices, their accessories and groups of products not intended for medical purposes listed in Annex XVI to the aforementioned Regulation (EU) 2017/745.

III.-Medical device accessory means: any article which, without itself being a medical device, is intended by its manufacturer to be used with a given medical device, or with several of them, to enable that medical device to be used in accordance with its intended purpose, or to contribute specifically and directly to the medical function of the medical device according to its intended purpose.

Mariela Petrova

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Mariela Petrova

Mariela Petrova

Avocate au Barreau de Paris

Toque #C2396

15+ Years In Corporate Practice

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