Section 4: Conditions for placing on the market and putting into service.

Any medical device placed on the market or put into service in France must bear the CE mark certifying that it meets the conditions set out in article R. 5211-17. However, CE marking is not required for custom-made devices and for devices which are to be the subject of clinical investigations.

The presentation, at scientific or technical meetings, exhibitions or demonstrations, of medical devices which do not comply with the provisions of this Title is authorised provided that a visible sign clearly indicates that these devices may not be placed on the market or put into service until they have been brought into conformity.

The CE marking may be affixed to a medical device only if it complies with the essential health and safety requirements referred to in Section 5 of this Chapter and has undergone the certification procedures applicable to it. Where a device falling within the scope of this Title is also governed by other provisions transposing European Union directives and providing for the affixing of the CE marking, the latter may…

The affixing of marks or inscriptions on a medical device, on its packaging or on the instructions for use which are likely to mislead as to the meaning or form of the CE marking is prohibited. Any other mark may be affixed, provided that it does not reduce the visibility or legibility of the CE marking.

The CE mark is affixed under the responsibility of the manufacturer or his authorised representative. Its form and dimensions are laid down by order of the Minister for Health. The CE marking must be affixed visibly, legibly and indelibly to the medical device or to the packaging ensuring sterility, as well as to the commercial packaging and to the instructions for use. The CE marking is accompanied, where appropriate, by…

No medical device may be placed on the market or put into service in France unless it complies with the essential health and safety requirements referred to in section 5 of this chapter which apply to it. It must also be duly supplied, correctly installed, maintained and used in accordance with its intended purpose. This conformity is assessed and certified either in France, in accordance with the procedures laid down…

Medical devices which comply with the standards applicable to them, 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 health and safety requirements set out in section 5 of this chapter. The standards mentioned in the first paragraph include the monographs of the European Pharmacopoeia relating in particular to surgical sutures and…

On duly justified request, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may authorise, by way of derogation, the placing on the market and putting into service of devices which have not undergone certification procedures, but whose use is of interest for the protection of health.

The labelling of a medical device given to the end user or patient, the accompanying leaflet and any other information relating to its operation or use must include a version written in French.