17 MARS 2009. - Arrêté royal modifiant l'arrêté royal du 18 mars 1999 relatif aux dispositifs médicaux. - Erratum
A la page 24477 du Moniteur belge du 27 mars 2009, édition 2, le texte du point e) doit être lu comme suit :
e) au point 3.2, le point c) est remplacé comme suit :
c) des procédures permettant de contrôler et de vérifier la conception des produits, y compris la documentation y afférente, et notamment :
- une description générale du produit, y compris les variantes envisagées et leur(s) utilisation(s) prévue(s),
- des spécifications de conception, y compris les normes qui seront appliquées et les résultats de l'analyse de risques ainsi que de la description des solutions adoptées pour satisfaire aux exigences essentielles qui s'appliquent aux produits lorsque les normes visées à l'article 3, § 3, ne sont pas appliquées entièrement,
- les techniques de contrôle et de vérification de la conception ainsi que les procédés et les actions systématiques qui seront utilisés lors de la conception des produits,
- si le dispositif doit être raccordé à un (d') autre(s) dispositif(s) pour pouvoir fonctionner conformément à sa destination, la preuve qu'il satisfait aux exigences essentielles doit être apportée lorsqu'il est raccordé à l'un quelconque de ces dispositifs ayant les caractéristiques indiquées par le fabricant,
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