Aug
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DISPOSITIFS MEDICAUX : conditions de la revente d'occasion

Au JO du 18 août 2011 a été publié le décret n° 2011-968 du 16 août 2011 relatif à la revente des dispositifs médicaux d'occasion.

Complétant la partie règlementaire du Code de la santé publique, ce décret détermine les modalités d'application des règles relatives à la revente des dispositifs médicaux d'occasion prévues à l'article L. 5212-1 du même code.

La personne responsable de la cession d'un dispositif médical d'occasion visé sur une liste règlementaire est soumise à une obligation d'établir une attestation technique préalable certifiant que le dispositif médical d'occasion a fait l'objet d'une maintenance régulière. Cette attestation mentionne également les indications nécessaires pour identifier le dispositif médical, la date de première mise en service ou, dans le cas où le dispositif n'a jamais été mis en service, la date de première acquisition.

Le texte nouveau précise également les conditions dans lesquelles la personne responsable de la cession est dispensée de l'obligation d'établir l'attestation technique.

Enfin, il fixe la liste des documents devant être fournis au bénéficiaire par la personne responsable de la cession, à l'appui de l'attestation qui aura été établie.

Le nouveau dispositif entrera en vigueur le 1er septembre 2011, sous réserve de la publication de l'arêté fixant la liste des dispositifs médicaux concernés.

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