La procedura ordinaria finalizzata a certificare la conformità delle mascherine chirurgiche, quali dispositivi medici, prevede che il fabbricante, oltre a notificare il DM (dispositivo medico) presso la banca dati del Ministero della Salute prima di immettere il prodotto sul mercato nazionale, debba garantire la conformità tecnica del DM stesso ai requisiti essenziali affinché il prodotto sia sicuro ed efficace con la dichiarazione di conformità e con l’apposizione del marchio CE sulla confezione commerciale o sull’involucro sterile, sotto la sua esclusiva responsabilità.
La suddetta procedura prevede che le mascherine chirurgiche “non siano soggette ad autorizzazione ministeriale né a valutazione della conformità da parte di un Organismo Notificato (fatta eccezione per quelle sterili), ma il fabbricante deve: 1) garantire la conformità tecnica del DM ai requisiti essenziali affinché il prodotto sia sicuro ed efficace con la dichiarazione di conformità e l’apposizione del marchio CE sotto la sua esclusiva responsabilità; 2) notificare il DM nella banca dati del Ministero della salute prima di immettere il DM sul mercato nazionale” (Circolare del Ministero della Salute n. 0003572 del 18.3.2020).
Con riferimento all’attività di sorveglianza l’art. 17 del D. Lgs. 24 febbraio 1997, n. 46 (attuativo della direttiva europea 93/42/CCE concernente i dispositivi medici) rubricato “Sorveglianza del mercato e verifica di conformità”, dichiara che “[…]
2. Al fine di verificare la conformità dei dispositivi medici alle prescrizioni del presente decreto, le Amministrazioni vigilanti di cui al comma 1 hanno facoltà di disporre verifiche e controlli mediante i propri uffici centrali o periferici.
3.Gli accertamenti possono essere effettuati, anche con metodo a campione, presso il produttore, i depositi sussidiari del produttore, i grossisti, gli importatori, i commercianti o presso gli utilizzatori. A tal fine è consentito: a) l’accesso ai luoghi di fabbricazione o di immagazzinamento dei prodotti; b) l’acquisizione di tutte le informazioni necessarie all’accertamento; c) il prelievo temporaneo e a titolo gratuito di un singolo campione per l’esecuzione di esami e prove.
4. Per l’effettuazione delle eventuali prove tecniche, le Amministrazioni di cui al comma 1 possono avvalersi di organismi tecnici dello Stato o di laboratori conformi alla norme della serie EN 45.000 autorizzati con decreto del Ministero della salute, di concerto con il Ministero dello sviluppo economico.
5. Al fine di agevolare l’attività di sorveglianza e di verifica, il fabbricante o il suo mandatario predispone e mantiene a disposizione degli organi di sorveglianza la documentazione prevista per la valutazione della conformità, nonché copia delle istruzioni e delle etichette in italiano fornite con i dispositivi messi in servizio in Italia, per il periodo indicato all’allegato 2, punto 6.1, o all’allegato 3, punto 7.3, o all’allegato 4, punto 7, o all’allegato 5, punto 5.1 o, infine, all’allegato 6, punto 5.1.
6. Ferma restando l’applicazione delle sanzioni di cui all’articolo 23, il Ministero della salute, quando accerta l’indebita marcatura CE dei dispositivi medici, o l’assenza della stessa, in violazione alle disposizioni del presente decreto, ordina al fabbricante o al mandatario di adottare tutte le misure idonee a far venire meno la situazione di infrazione fissando un termine per adempiere non superiore a trenta giorni.
7. Decorso inutilmente il termine di cui al comma 6, il Ministero della salute ordina l’immediato ritiro dal commercio dei dispositivi medici, a cura e spese del soggetto destinatario dell’ordine.
8. Nel caso in cui l’infrazione continui il Ministero della salute adotta le misure atte a garantire il ritiro dal commercio, a spese del fabbricante o del suo mandatario.
9. Le disposizioni di cui ai commi 6, 7 e 8 si applicano anche se la marcatura CE è stata apposta in base alle procedure di cui al presente decreto, ma impropriamente, su prodotti che non sono contemplati dal decreto stesso”.
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