The purpose of materiovigilance is to monitor incidents or risks of incidents resulting from the use of medical devices which are defined in article L. 5211-1 and come under this title by virtue of articles R. 5211-1 to R. 5211-3. It is carried out on medical devices after they have been placed on the market.
Materiovigilance involves : 1° Reporting and recording the incidents or risks of incidents mentioned in articles R. 5212-14 and R. 5212-15; 2° Recording, evaluating and using this information for prevention purposes; 3° Carrying out any studies or work relating to the safe use of medical devices; 4° Carrying out and monitoring any corrective action decided upon.
The exercise of material vigilance may involve, in addition to the communication by the manufacturer of the documents mentioned in Article R. 5211-26, access to data in the pre-clinical experimental file and to data relating to clinical investigations, in particular the report on clinical investigations mentioned in Article R. 5211-37 and the information listed in Article R. 5211-38, as well as access to information relating to the design, manufacture, storage,…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) carries out his duties relating to material vigilance under the conditions defined in Article R. 5311-2 and ensures compliance with the monitoring procedures organised by this chapter. It informs the manufacturer(s) concerned when the facts reported are brought to its attention by a…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall inform without delay of any incident or risk of incident defined in Article L. 5212-2: the Etablissement Français du Sang (French Blood Establishment), with regard to medical devices used in the collection, manufacture and administration of blood-derived products; -the Agence de la biomédecine, for medical devices used in the collection, processing, preservation and…
The regional material vigilance and reactovigilance coordinators carry out their vigilance duties under the conditions defined in article R. 1413-61-4.
Any health establishment or health cooperation group which uses or supplies medical devices or makes such devices available to its members, as well as any association distributing medical devices at home and appearing on a list drawn up by the Director General of the Agence nationale de sécurité du médicament et des produits de santé, must appoint a local materialovigilance correspondent. However, below an activity threshold set by order of…
Every manufacturer of medical devices, or its authorised representative, appoints a material vigilance correspondent and communicates his name to the Director General of the Agence nationale de sécurité du médicament et des produits de santé.
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…
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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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