Part five: Health products

Incidents or risks of incidents as defined in Article L. 5212-2 must be reported immediately.

The following incidents may be reported: 1° A noxious and unintended reaction occurring during the use of a medical device in accordance with its intended purpose; 2° A noxious and unintended reaction resulting from the use of a medical device that does not comply with the manufacturer’s instructions; 3° Any malfunction or alteration in the characteristics or performance of a medical device; 4° Any incorrect information, omission or inadequacy in…

The reports, whether mandatory or optional, provided for in articles R. 5212-14 and R. 5212-15 are made by manufacturers or their representatives, users or third parties who observe or are aware of incidents or risks of incidents involving a medical device. Third parties are considered to be persons who are neither manufacturers or their agents or users of medical devices nor patients. In particular, distributors of medical devices fall into…

Reports are made : 1° To the local materiovigilance correspondent when these reports are made by users or third parties who carry out their duties in one of the establishments or associations mentioned in article R. 5212-12, in particular when these users or third parties are members of the health professions or members of the administrative or technical staff ; 2° Directly to the Director General of the Agence nationale…

When the facts mentioned in Article L. 5212-2 are brought to the attention of the Director General of the Agence nationale de sécurité du médicament et des produits de santé by a user or a third party, in particular an authorised body, the Director General shall inform the manufacturer or manufacturers concerned.

When informed of one of the events mentioned in Article L. 5212-2, the Director of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) will, if possible, carry out an assessment jointly with the manufacturer of the device in question and, if necessary, take the measures provided for in Articles L. 5312-1 to L. 5312-3.

Without prejudice to the obligations to provide information laid down by Article L. 5212-2 or by any other legislative or regulatory provision, the staff of the Agence nationale de sécurité du médicament et des produits de santé, those of the authorised bodies and the laboratories to which these bodies may have recourse, as well as all persons involved in the procedures provided for in this Title, are required to keep…

I.-Local materiovigilance correspondents are responsible for: 1° Forwarding without delay, with the exception of the reports mentioned in b, to the Director General of the Agence nationale de sécurité du médicament et des produits de santé: a) Any report of an incident or risk of incident made to them in application of Article R. 5212-14; b) On a quarterly basis, any report of an incident or malfunction made to them…

Manufacturers of medical devices and the companies and organisations operating these devices shall, at the reasoned request of the Director of the Agence nationale de sécurité du médicament et des produits de santé, provide any information mentioned in Article R. 5212-3 or carry out any investigations or work concerning the risks of incidents that these devices may present. The information, investigations or work requested in this way are necessary for…