CLASSIFICAZIONE PRODOTTO

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 PRODUCT CLASSIFICATION

Margi, per determinare i requisiti generici necessari per la conduzione dei proprio processi produttivi, fa riferimento alla Normativa ISO 15378:2017, intitolata: “Primary packaging materials for medical products— Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)" La produzione MARGI si identifica fedelmente nel soggetto di cui si occupa il Comitato Tecnico, ISO TC/76: “Transfusion, in fusion and injection, and blood processing equipment for medical and pharmaceutical use” Sebbene il proprio prodotto non è classificato come Dispositivo Medico, viene garantito l’allineamento ai requisiti applicabili descritti nel regolamento inerenti i Dispositivi Medici (UE) 2107/745.

The organization, to determine the generic requirements necessary to manage its productive processes, refers to the ISO 15378:2017, titled: “Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to the good manufacturing practice (GMP)” Margi production is faithfully identified with the subject of the Technical Committee, ISO TC/76 “Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use”. Though the product self is not classified as “Medical Device”, the alignment to the applicable requirements described in the Medical Device Regulation (UE) 2017/745 is granted.