Section 3: Obligations of those involved in reactovigilance.

User healthcare professionals not practising in one of the establishments mentioned in 4° of Article R. 5222-3 or in a blood transfusion establishment who are aware of incidents or risks of incidents involving an in vitro diagnostic medical device shall declare them without delay to the Agence nationale de sécurité du médicament et des produits de santé. The user healthcare professionals mentioned in the first paragraph shall inform the manufacturers,…

User healthcare professionals working in one of the establishments mentioned in 4° of Article R. 5222-3 or in a blood transfusion establishment immediately report to the local reactovigilance correspondent any incidents or risks of incidents involving an in vitro diagnostic medical device of which they are aware. In an emergency, the healthcare professional will forward the report directly to the Director General of the Agence nationale de sécurité du médicament…

Manufacturers or their agents, importers and distributors shall declare without delay to the Director General of the Agence nationale de sécurité du médicament et des produits de santé any incidents or risks of incidents involving an in vitro diagnostic medical device of which they are aware. When importers or distributors report an incident or risk of incident, or when they are informed by a local reactovigilance correspondent or by a…

Local reactovigilance correspondents are responsible for : 1° Recording and analysing any reported incident or risk of incident likely to be due to an in vitro diagnostic medical device; 2° Declaring without delay to the Director General of the Agence nationale de sécurité du médicament et des produits de santé any incident or risk of incident of which they are aware; 3° To inform the manufacturers, agents, importers or distributors…

At the request of the Director General of the Agence nationale de sécurité du médicament et des produits de santé, the manufacturer or its authorised representative shall provide any information relating to the characteristics, design, composition, analytical evaluation file, manufacture, storage, distribution, instructions for use, batch control procedures and results before release and during use, the making available, use and traceability of in vitro diagnostic medical devices and their sale….

The manufacturer or his authorised representative, the importer or the distributor is required to keep, for each incoming and outgoing transaction, at least the following information: 1° The date of the transaction ; 2° The name of the in vitro diagnostic medical device; 3° The quantity received or supplied, with batch numbers; 4° The name and address of the supplier and recipient. For any delivery to a legal or natural…

For a new device, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may, at any time and for a period of two years following the declaration provided for in Article R. 5221-35, ask the manufacturer or his authorised representative to provide a report on the experience acquired with this device after it has been placed on the market.