Chapter II: Materials vigilance

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…