Manufacturers who place in vitro diagnostic medical devices on the French market and who do not have their registered office on the territory of a Member State of the European Union or a party to the Agreement on the European Economic Area must first appoint an authorised representative.
The declaration provided for in article L. 5221-3 is made by the manufacturer or his authorised representative, the importer, distributor or exporter of in vitro diagnostic medical devices. The same natural or legal person may declare several activities. The manufacturer or its authorised representative is not required to declare itself as an importer or distributor for the in vitro diagnostic medical devices it places on the market. Importers are not…
The content and methods of presentation of the declaration are laid down, on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by order of the Minister for Health. This order may provide for specific content and presentation procedures for establishments engaged in the manufacture of in vitro diagnostic medical devices mentioned in Article L. 5221-5.
The Director General of the Agence nationale de sécurité du médicament et des produits de santé is notified of any changes to the information contained in the declaration.
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.
Our French business lawyers are here to help.
We offer a FREE evaluation of your case.
Call us at +33 (0) 1 84 88 31 00 or send us an email.
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
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
Resources
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
Useful links
Our French business lawyers are here to help.
We offer a FREE evaluation of your case.
Call +33 (0) 1 84 88 31 00 or send us an email.
All information exchanged through this website will be communicated to lawyers registered with a French Bar and will remain confidential.
