Each user department of a medical device on the list provided for in Article R. 5212-36 completes the information mentioned in Article R. 5212-38 by recording: -the date of use ; the identification of the patient, and in particular his surname, first name and date of birth; – the name of the doctor or surgeon; -the name of the user doctor or dental surgeon.
The medical file referred to in article R. 1112-2 must include: identification of the medical device: name, serial or batch number, name of the manufacturer or its authorised representative; – date of use -the date of use ; -the name of the user doctor or dental surgeon.
Doctors and dental surgeons who use medical devices on the list provided for in Article R. 5212-36, who carry out their activity outside a health or cosmetic surgery establishment, record the data necessary for traceability in the patient’s medical file, if this exists, or, failing this, in any document which makes it possible to locate and identify the batch from which the medical device used on a patient originates. They…
At the end of the care or cosmetic surgery procedures using a medical device on the list provided for in article R. 5212-36, the patient is given a document stating: -the identification of the medical device used: name, serial or batch number, name of the manufacturer or its authorised representative and brand; -the place and date of use; -the name of the user doctor or dental surgeon; whether the product…
For the application of the provisions of this chapter, army hospitals are considered to be public health establishments.
Advertising to the public for a medical device : 1° Is designed in such a way that the advertising nature of the message is obvious and the product is clearly identified as a medical device; 2° Specify the date on which it was drawn up or the date of the last modification and include at least the following information: a) The name or commercial reference of the medical device ;…
Advertising of a medical device to healthcare professionals is tailored to the target audience. It specifies the date on which it was drawn up or the date of the last modification and includes at least the following information: 1° The name or trade reference of the medical device; 2° The purpose assigned to the medical device by its manufacturer and for which it is advertised, together with the characteristics and…
The information contained in each advertisement must be accurate, up-to-date, verifiable and sufficiently complete to enable, as appropriate, the general public to understand the intended use of the medical device and professionals to appreciate the characteristics and performance of the medical device. Quotations, tables and other illustrations borrowed from medical journals or scientific works and used in advertising must be faithfully reproduced and their exact source specified. Advertising may not…
Where the Director General of the Agence nationale de sécurité du médicament et des produits de santé finds that advertising for a medical device, which is not covered by the provisions of Articles R. 5213-5 to R. 5213-11, is being disseminated under conditions which contravene the provisions of Article L. 5213-2 and of this section, he may give formal notice to the person on whose behalf the advertising is being…
The application for authorisation to advertise the medical devices referred to in Article L. 5213-4 shall be sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé by the person for whose benefit the advertising is to be disseminated, by registered letter or by electronic means with acknowledgement of receipt or delivered against receipt. Each application for authorisation must be accompanied by…
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75001, Paris France
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is a Registered Trademark of
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182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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