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medici. Il Ministero precisa: possibile non dare la dichiarazione al paziente che però deve essere informato. Il prescrittore deve firmare una ricevuta al fabbricante","dispositivi-medici-ministero-precisa-possibile-dare","Dopo l’approvazione della direttiva 2007\u002F47\u002FCEE, che modifica la 93\u002F42, concernente i dispositivi medici, recepita in Italia con il D. Lgs. n. 37 del 25 gennaio 2010 il ministero della Salute ha…","\u003Cp>Dopo l’approvazione della direttiva 2007\u002F47\u002FCEE, che modifica la 93\u002F42, concernente i dispositivi medici, recepita in Italia con \u003Ca href=\"\u002Farticoli\u002Fdispositivi-medici-misura-cosa-cambia-dichiarazione\">il D. Lgs. n. 37 del 25 gennaio 2010\u003C\u002Fa> il ministero della Salute ha emanato il 4 giugno scorso una circolare attraverso la quale chiarisce alcuni aspetti della “gestione” della dichiarazione di conformità tra paziente\u002Fproscrittore\u002Ffabbricante.\u003C\u002Fp>\u003Cp>Il particolare, nei casi in cui il dispositivo su misura venga consegnato dal fabbricante al medico o altro soggetto prescrittore, -si legge nella circolare- quest’ultimo avrà cura di acquisire dal fabbricante, auspicabilmente in due copie, la Dichiarazione di cui ai citati allegati VIII e 6; si suggerisce che il prescrittore sottoscriva contestualmente una ricevuta da restituire al fabbricante. Una delle due copie della Dichiarazione acquisita sarà conservata a cura del prescrittore, mentre l’altra copia sarà gestita secondo le stesse modalità descritte:\u003C\u002Fp>\u003Cp>a. il paziente ritira copia della dichiarazione e sottoscrive una ricevuta (Modello Allegato 3, parte I) che sarà conservata a cura del prescrittore;\u003C\u002Fp>\u003Cp>b. il paziente non ritiene, al momento della consegna del dispositivo, di ritirare copia della dichiarazione. 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