Article R5221-1 of the French Public Health Code
November 1, 2023
The provisions of this Title apply to in vitro diagnostic medical devices as defined in Article L. 5221-1.
The provisions of this Title apply to in vitro diagnostic medical devices as defined in Article L. 5221-1.
Where an in vitro diagnostic medical device forms an inseparable unit with a device which, if used separately, could be considered to be a medical device within the meaning of Article L. 5211-1 and whose action is ancillary to that of the in vitro diagnostic medical device, the latter is governed by the provisions of this Title, without prejudice to the application of the provisions of Title I with regard…
The provisions of this Title do not apply to: 1° Instruments, apparatus, equipment, materials or other articles, including software, intended to be used for research purposes without pursuing medical objectives ; 2° Reference materials certified at international level and materials used in programmes for the external assessment of the quality of analyses carried out by medical laboratories, with the exception of calibration agents and control materials which enable the user…
For the purposes of this Title, the following definitions shall apply 1° Accessory means any article which is intended by its manufacturer to be used principally with an in vitro diagnostic medical device in order to enable the latter to be used in accordance with its intended purpose, with the exception of invasive medical devices intended for taking samples and medical devices placed in direct contact with the human body…
The definitions given in 1°, 3°, 4° and 5° of Article R. 5211-4 are applicable to in vitro diagnostic medical devices.
In vitro diagnostic medical devices, other than in vitro diagnostic medical devices undergoing performance evaluation, are classified in two categories: 1° In vitro diagnostic medical devices whose reliability is a prerequisite for proper patient care and whose failures are likely to cause a serious health risk. These include in vitro diagnostic medical devices intended for self-diagnosis, as well as in vitro diagnostic medical devices, the list of which is established,…
In the event of disagreement on the application of the classification rules between the manufacturer of an in vitro diagnostic medical device and an authorised body involved in the conformity assessment procedures provided for in this Title, the Director General of the Agence nationale de sécurité du médicament et des produits de santé shall determine the certification procedure to which the device in question is subject.
Without prejudice to the provisions of Article R. 5221-9, in vitro diagnostic medical devices which comply with the standards relating to them and transposing the harmonised European standards, the references of which have been published in the Journal officiel de la République française, are presumed to comply with the essential requirements defined in Section 5 of this chapter.
In vitro diagnostic medical devices appearing on the list established by the order referred to in Article R. 5221-6, designed and manufactured in accordance with common technical specifications published in the Official Journal of the European Union and establishing performance assessment and reassessment criteria, batch release criteria, reference methods and materials, are, within the scope of these specifications, presumed to comply with the essential requirements. Manufacturers are required to comply…
All in vitro diagnostic medical devices imported, placed on the market or put into service must bear the CE mark. However, CE marking is not required for devices undergoing a performance evaluation or for the devices referred to in Article L. 5221-5.
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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