Section 5: Special rules for monitoring certain medical devices

For medical devices, the list of which is set by order of the Minister for Health on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products), material vigilance includes traceability rules from the time the medical devices are received in the healthcare or cosmetic surgery facility where they are…

The legal representative of health establishments, health cooperation groupings mentioned in article L. 6133-7 and cosmetic surgery establishments shall, after consulting the medical committee of the establishment mentioned inarticle L. 6144-2 or the medical conference of the establishment mentioned inarticle L. 6111-2, lay down the written procedure by which the data required for traceability is collected, stored and made accessible. This data is kept for a period of ten years….

The pharmacist in charge of managing the in-house pharmacy or, for establishments without an in-house pharmacy, the person in charge of ordering and managing stocks in the establishment, under the supervision of a healthcare professional, records all the data relating to the dispensing of medical devices on the list provided for in Article R. 5212-36. This record includes the following information: -the identification of each medical device: name, serial or…

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…