The purpose of vigilance of in vitro diagnostic medical devices, known as reactovigilance, is to monitor incidents and risks of incidents as defined in 1° of article R. 5222-2. It is carried out on all in vitro diagnostic medical devices after they have been placed on the market, as well as on the in vitro diagnostic medical devices mentioned in article L. 5221-5.
Reactovigilance involves : 1° The reporting and declaration of any incident or risk of incident consisting of a failure or alteration in the characteristics or performance of an in vitro diagnostic medical device, or an inadequacy in the labelling or instructions for use likely to lead or to have led directly or indirectly to adverse effects on human health; 2° Recording, evaluating and using this information to protect human health;…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall carry out his duties relating to reactovigilance under the conditions defined in Article R. 5311-2. He shall ensure compliance with the monitoring procedures organised by this chapter. When informed of an incident or risk of incident, or of the recall of an in vitro diagnostic medical device, the Director General will arrange for…
In each region, regional material vigilance and reactovigilance coordinators carry out their vigilance duties under the conditions defined in article R. 1413-61-4.
Any establishment mentioned in 4° of article R. 5222-3 and any blood transfusion establishment shall appoint a local reactovigilance correspondent. The local reactovigilance correspondent is a doctor or pharmacist with experience in the field of in vitro diagnostic medical devices. The healthcare cooperation group’s reactovigilance correspondent may be the reactovigilance correspondent for a healthcare establishment that is a member of the group. As soon as it is appointed, the identity…
All manufacturers of in vitro diagnostic medical devices, or their representatives, shall appoint a person to be responsible for reactovigilance, whose identity and position shall be communicated to the Director General of the Agence nationale de sécurité du médicament et des produits de santé.
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…
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is a Registered Trademark of
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182, rue de Rivoli
75001, Paris France
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Paris Bar Registration n° (Toque) C2396
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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