{"id":3095,"date":"2025-12-16T23:13:06","date_gmt":"2025-12-16T23:13:06","guid":{"rendered":"https:\/\/altrion-group.com\/?page_id=3095"},"modified":"2026-07-07T10:14:48","modified_gmt":"2026-07-07T10:14:48","slug":"uk-rp-dispositivi-medici","status":"publish","type":"page","link":"https:\/\/altrion-group.com\/it\/uk-rp-dispositivi-medici\/","title":{"rendered":"UKRP"},"content":{"rendered":"<div id='av-layout-grid-1'  class='av-layout-grid-container av-7nloit-088d9e4d481f209b19bd665b92c5c355 entry-content-wrapper main_color av-flex-cells  avia-builder-el-0  el_before_av_section  avia-builder-el-first  av-cell-min-height av-cell-min-height-50  container_wrap fullsize'   data-av_minimum_height_pc='50'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-7iksy5-8399baca393dd3014d334eff2171eb86\">\n.flex_cell.av-7iksy5-8399baca393dd3014d334eff2171eb86{\nvertical-align:middle;\nbackground:url(https:\/\/altrion-group.com\/wp-content\/uploads\/2023\/01\/UK-RP-1030x687-1.webp) 50% 50% no-repeat scroll #7faccd;\n}\n.responsive #top #wrap_all .flex_cell.av-7iksy5-8399baca393dd3014d334eff2171eb86{\npadding:0px 0px 0px 0px !important;\n}\n<\/style>\n<div class='flex_cell av-7iksy5-8399baca393dd3014d334eff2171eb86 av-gridrow-cell av_one_half no_margin  avia-builder-el-1  el_before_av_cell_one_half  avia-builder-el-first  content-align-middle av-zero-padding avia-full-stretch'  ><div class='flex_cell_inner'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lamlndza-867e3767e038d8ce182bfd3131e03a8b\">\n#top .hr.hr-invisible.av-lamlndza-867e3767e038d8ce182bfd3131e03a8b{\nheight:200px;\n}\n<\/style>\n<div  class='hr av-lamlndza-867e3767e038d8ce182bfd3131e03a8b hr-invisible  avia-builder-el-2  avia-builder-el-no-sibling '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n<\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-7eaf2t-13587f053fed9a03a610ec487eca6f29\">\n.flex_cell.av-7eaf2t-13587f053fed9a03a610ec487eca6f29{\nvertical-align:middle;\nbackground-color:#7faccd;\n}\n.responsive #top #wrap_all .flex_cell.av-7eaf2t-13587f053fed9a03a610ec487eca6f29{\npadding:50px 50px 50px 50px !important;\n}\n<\/style>\n<div class='flex_cell av-7eaf2t-13587f053fed9a03a610ec487eca6f29 av-gridrow-cell av_one_half no_margin  avia-builder-el-3  el_after_av_cell_one_half  avia-builder-el-last  content-align-middle'  ><div class='flex_cell_inner'><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lamls2p5-c7ae9284aa9a13f9f30fafafd51db32c\">\n#top .av-special-heading.av-lamls2p5-c7ae9284aa9a13f9f30fafafd51db32c{\npadding-bottom:10px;\ncolor:#ffffff;\nfont-size:34px;\n}\nbody .av-special-heading.av-lamls2p5-c7ae9284aa9a13f9f30fafafd51db32c .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-lamls2p5-c7ae9284aa9a13f9f30fafafd51db32c .av-special-heading-tag{\nfont-size:34px;\n}\n.av-special-heading.av-lamls2p5-c7ae9284aa9a13f9f30fafafd51db32c .special-heading-inner-border{\nborder-color:#ffffff;\n}\n.av-special-heading.av-lamls2p5-c7ae9284aa9a13f9f30fafafd51db32c .av-subheading{\nfont-size:15px;\n}\n\n@media only screen and (min-width: 480px) and (max-width: 767px){ \n#top #wrap_all .av-special-heading.av-lamls2p5-c7ae9284aa9a13f9f30fafafd51db32c .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n\n@media only screen and (max-width: 479px){ \n#top #wrap_all .av-special-heading.av-lamls2p5-c7ae9284aa9a13f9f30fafafd51db32c .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<div  class='av-special-heading av-lamls2p5-c7ae9284aa9a13f9f30fafafd51db32c av-special-heading-h1 custom-color-heading blockquote modern-quote  avia-builder-el-4  el_before_av_hr  avia-builder-el-first  av-inherit-size'><h1 class='av-special-heading-tag '  itemprop=\"headline\"  ><strong style=\"color: #fff; font-size: 34px;\">UKRP PER DISPOSITIVI MEDICI<\/strong><\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lammyevo-b6b012543a8cd77fa59d26f507e6989a\">\n#top .hr.av-lammyevo-b6b012543a8cd77fa59d26f507e6989a{\nmargin-top:10px;\nmargin-bottom:10px;\n}\n.hr.av-lammyevo-b6b012543a8cd77fa59d26f507e6989a .hr-inner{\nwidth:50px;\nborder-color:#ffffff;\n}\n<\/style>\n<div  class='hr av-lammyevo-b6b012543a8cd77fa59d26f507e6989a hr-custom  avia-builder-el-5  el_after_av_heading  el_before_av_textblock  hr-left hr-icon-no'><span class='hr-inner inner-border-av-border-fat'><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-72sk5p-7799907f0db07ff7d037b986950eade5\">\n#top .av_textblock_section.av-72sk5p-7799907f0db07ff7d037b986950eade5 .avia_textblock{\ncolor:#ffffff;\n}\n<\/style>\n<section  class='av_textblock_section av-72sk5p-7799907f0db07ff7d037b986950eade5 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><h2>Persona Responsabile nel Regno Unito per dispositivi medici<\/h2>\n<p>Rappresentanza MHRA<\/p>\n<\/div><\/section><\/p>\n<\/div><\/div>\n<\/div>\n<div id='av_section_1'  class='avia-section av-uw1x1-7657275774aaf665c456ddf7d4e909d0 main_color avia-section-default avia-no-border-styling  avia-builder-el-7  el_after_av_layout_row  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-3095'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-syo8d-1f42d04d2346838f771ac9c9ace80e59\">\n.flex_column.av-syo8d-1f42d04d2346838f771ac9c9ace80e59{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-syo8d-1f42d04d2346838f771ac9c9ace80e59 av_four_fifth  avia-builder-el-8  avia-builder-el-no-sibling  first flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-a7e1p-6bdefd87f611a2ad6687b37efec4172a '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p><span style=\"font-weight: 400;\">I fabbricanti extra-UK che desiderano immettere dispositivi medici o dispositivi diagnostici in vitro nel mercato della Gran Bretagna, inclusi Inghilterra, Scozia e Galles, devono nominare un <\/span><b>UK Responsible Person (UKRP)<\/b><span style=\"font-weight: 400;\">, come previsto dal UK Medical Devices Regulations 2002, come modificato.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Il UKRP agisce come <\/span><b>rappresentante ufficiale del fabbricante estero<\/b><span style=\"font-weight: 400;\"> presso l&#8217;MHRA, la Medicines and Healthcare products Regulatory Agency, e aiuta a garantire che i prodotti immessi sul mercato UK siano conformi al <\/span><b>quadro normativo applicabile<\/b><span style=\"font-weight: 400;\">. Questo ruolo \u00e8 essenziale per i fabbricanti che devono registrare i dispositivi medici in Gran Bretagna, mantenere la documentazione tecnica e regolatoria, gestire gli obblighi di vigilanza e rispondere alle comunicazioni dell&#8217;MHRA.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">ALTRION, attraverso la propria entit\u00e0 con sede a Londra, fornisce la <\/span><b>rappresentanza UKRP completa per dispositivi medici e IVD<\/b><span style=\"font-weight: 400;\">. Il servizio supporta la registrazione MHRA, il monitoraggio della documentazione, la conformit\u00e0 dell&#8217;etichettatura, il coordinamento della vigilanza e la comunicazione regolatoria continua in linea con i requisiti MHRA.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Nomina del UKRP e registrazione MHRA<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">ALTRION <\/span><b>supporta la<\/b> <b>nomina formale<\/b> <b>del UK Responsible Person<\/b><span style=\"font-weight: 400;\"> and <\/span><b>manages MHRA registration for all device classes<\/b><span style=\"font-weight: 400;\">, incluse le Classi I, IIa, IIb, III e IVD. Questo servizio consente ai fabbricanti extra-UK di stabilire la rappresentanza regolatoria richiesta per l&#8217;immissione dei dispositivi nel mercato della Gran Bretagna.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">La nomina del UKRP \u00e8 un passaggio fondamentale per i fabbricanti privi di presenza legale nel Regno Unito. ALTRION aiuta a strutturare il processo di rappresentanza e supporta la registrazione dei dispositivi presso l&#8217;MHRA, garantendo che le informazioni richieste siano correttamente inviate e gestite.<\/span><\/p>\n<\/div><\/section><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lavkffm6-89a19ddf9e9265d6c9bb53d8c559b991\">\n.avia-section.av-lavkffm6-89a19ddf9e9265d6c9bb53d8c559b991{\nbackground-color:#22689e;\nbackground-image:unset;\n}\n<\/style>\n<div id='av_section_2'  class='avia-section av-lavkffm6-89a19ddf9e9265d6c9bb53d8c559b991 main_color avia-section-default avia-no-border-styling  avia-builder-el-10  el_after_av_section  el_before_av_section  avia-bg-style-scroll av-minimum-height av-minimum-height-20 av-height-percent  container_wrap fullsize'   data-av_minimum_height_pc='20' data-av_min_height_opt='percent'><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-3095'><div class='entry-content-wrapper clearfix'>\n<div  class='flex_column av-5ocupa-adf4f9344bafb192a2e6bd8a6777a31c av_one_third  avia-builder-el-11  el_before_av_one_third  avia-builder-el-first  first flex_column_div  '     ><\/div><div  class='flex_column av-4h150e-095bae0466831e0353062471677caf9b av_one_third  avia-builder-el-12  el_after_av_one_third  el_before_av_one_third  flex_column_div  '     ><div  class='avia-button-wrap avia-button-center  avia-builder-el-13  avia-builder-el-no-sibling '>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lavki7rj-12bed064bd5d1ff36e124564a6fea451\">\n#top #wrap_all .avia-button.av-lavki7rj-12bed064bd5d1ff36e124564a6fea451:hover{\ncolor:white;\ntransition:all 0.4s ease-in-out;\n}\n#top #wrap_all .avia-button.av-lavki7rj-12bed064bd5d1ff36e124564a6fea451:hover .avia-svg-icon svg:first-child{\nfill:white;\nstroke:white;\n}\n<\/style>\n<a href='#modulo-contatto' class='av-icon-on-hover avia-color-theme-color avia-font-color-theme-color avia-button avia-button-fullwidth av-lavki7rj-12bed064bd5d1ff36e124564a6fea451 avia-icon_select-yes-right-icon avia-color-theme-color'   aria-label=\"Contattaci\"><span class='avia_iconbox_title' >Contattaci<\/span><span class='avia_button_icon avia_button_icon_right avia-iconfont avia-font-entypo-fontello' data-av_icon='\ue805' data-av_iconfont='entypo-fontello' ><\/span><div class='av-button-description av-button-description-below'><p>Prenota il servizio<\/p>\n<\/div><span class='avia_button_background avia-button avia-button-fullwidth avia-color-theme-color-highlight'><\/span><\/a><\/div><\/div><div  class='flex_column av-2sjhy6-df14176a0df0a382aae77749df66c5ae av_one_third  avia-builder-el-14  el_after_av_one_third  avia-builder-el-last  flex_column_div  '     ><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lavk1b0k-50841b155ac05d20232abba4632fcbba\">\n.avia-section.av-lavk1b0k-50841b155ac05d20232abba4632fcbba{\nbackground-color:#e6e7e6;\nbackground-image:unset;\n}\n<\/style>\n<div id='av_section_3'  class='avia-section av-lavk1b0k-50841b155ac05d20232abba4632fcbba main_color avia-section-default avia-no-border-styling  avia-builder-el-15  el_after_av_section  el_before_av_layout_row  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-3095'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2apcny-03ae0a29978934791ae118441d50876c\">\n.flex_column.av-2apcny-03ae0a29978934791ae118441d50876c{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-2apcny-03ae0a29978934791ae118441d50876c av_four_fifth  avia-builder-el-16  avia-builder-el-no-sibling  first flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-lavk2t0l-856a369e2f0f62a8578d59a9bc3052af '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><div id=\"1246208796\" class=\"u_1246208796 dmNewParagraph\">\n<div>\n<h2><span style=\"font-weight: 400;\">Verifica della documentazione tecnica e dell&#8217;etichettatura<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">ALTRION verifica la <\/span><b>documentazione tecnica<\/b><span style=\"font-weight: 400;\"> e la <\/span><b>conformit\u00e0 dell&#8217;etichettatura<\/b><span style=\"font-weight: 400;\"> per garantire la conformit\u00e0 al UK MDR 2002 e alle linee guida MHRA. Ci\u00f2 include la revisione della documentazione tecnica e regolatoria del fabbricante e la verifica che l&#8217;etichettatura e le Istruzioni per l&#8217;Uso siano coerenti con i requisiti UK applicabili.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Una documentazione e un&#8217;etichettatura corrette sono essenziali per l&#8217;accesso al mercato UK. ALTRION supporta i fabbricanti aiutando a <\/span><b>mantenere questi materiali allineati<\/b> <b>al quadro normativo<\/b><span style=\"font-weight: 400;\"> e accessibili per la revisione dell&#8217;MHRA quando richiesto.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Gestione della registrazione MHRA DORS<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">ALTRION gestisce le <\/span><b>attivit\u00e0 di registrazione nel database MHRA DORS<\/b><span style=\"font-weight: 400;\">, il Device Online Registration System. Ci\u00f2 include il supporto all&#8217;invio delle informazioni sul dispositivo e l&#8217;aiuto ai fabbricanti nell&#8217;ottenimento della prova di listing del dispositivo nel database DORS.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">La registrazione DORS \u00e8 un <\/span><b>passaggio pratico e importante per la conformit\u00e0 UKRP<\/b><span style=\"font-weight: 400;\">. ALTRION aiuta i fabbricanti a gestire questo processo in modo organizzato, riducendo l&#8217;incertezza sui flussi di lavoro della registrazione e supportando una comunicazione pi\u00f9 chiara con l&#8217;MHRA.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Coordinamento della vigilanza e reporting PMS<\/span><\/h2>\n<p><b>La conformit\u00e0 post-market<\/b><span style=\"font-weight: 400;\"> \u00e8 una parte centrale del ruolo UKRP. ALTRION supporta il <\/span><b>coordinamento della vigilanza<\/b><span style=\"font-weight: 400;\"> e il <\/span><b>reporting della Sorveglianza Post-Market (PMS)<\/b><span style=\"font-weight: 400;\">, inclusa la presentazione di report su incidenti gravi e Azioni Correttive di Sicurezza sul Campo (FSCA) all&#8217;MHRA ove richiesto.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Questo servizio aiuta i fabbricanti a <\/span><b>monitorare le prestazioni del dispositivo dopo l&#8217;immissione in commercio<\/b><span style=\"font-weight: 400;\"> e a rispondere adeguatamente agli eventi relativi alla sicurezza. Coordinando le attivit\u00e0 PMS e di vigilanza, ALTRION supporta la conformit\u00e0 continua alle aspettative regolatorie UK durante l&#8217;intero ciclo di vita del prodotto.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Collegamento continuo con l&#8217;MHRA<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">ALTRION agisce come <\/span><b>punto di contatto ufficiale <\/b><span style=\"font-weight: 400;\">per le comunicazioni regolatorie e le richieste di documenti dall&#8217;MHRA. Questo collegamento continuo aiuta i fabbricanti extra-UK a gestire le <\/span><b>interazioni con le autorit\u00e0<\/b><span style=\"font-weight: 400;\"> attraverso un rappresentante con sede a Londra e conoscenza del quadro normativo UK.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Una comunicazione chiara con l&#8217;MHRA \u00e8 importante quando sorgono domande, richieste di documenti, report di vigilanza o aggiornamenti delle registrazioni. ALTRION aiuta i fabbricanti a mantenere reattivit\u00e0 e continuit\u00e0 nelle loro comunicazioni regolatorie.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Archiviazione della documentazione tecnica e regolatoria<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">ALTRION conserva e archivia la <\/span><b>manufacturer\u2019s technical and regulatory documentation<\/b><span style=\"font-weight: 400;\">, garantendo l&#8217;accessibilit\u00e0 per la revisione dell&#8217;MHRA su richiesta. Ci\u00f2 include <\/span><b>mantenere la documentazione pertinente organizzata e disponibile<\/b><span style=\"font-weight: 400;\"> affinch\u00e9 il fabbricante possa dimostrare la conformit\u00e0 regolatoria continua quando necessario.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Una manutenzione documentale affidabile supporta sia l&#8217;<\/span><b>accesso al mercato sia gli obblighi post-market<\/b><span style=\"font-weight: 400;\">. ALTRION aiuta i fabbricanti a preservare un registro regolatorio chiaro durante l&#8217;intera relazione UKRP.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Verifica annuale di conformit\u00e0<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">ALTRION fornisce la <\/span><b>verifica annuale di conformit\u00e0<\/b><span style=\"font-weight: 400;\"> per confermare la <\/span><b>conformit\u00e0 continua di dispositivi, etichettatura e dichiarazioni<\/b><span style=\"font-weight: 400;\">. Questa attivit\u00e0 aiuta i fabbricanti a verificare se la loro documentazione e le informazioni sul prodotto rimangono <\/span><b>allineate alle aspettative regolatorie UK<\/b><span style=\"font-weight: 400;\"> nel tempo.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">La verifica annuale \u00e8 particolarmente utile per i fabbricanti con pi\u00f9 dispositivi, documentazione in evoluzione o requisiti di mercato in cambiamento. ALTRION supporta questo processo nell&#8217;ambito del proprio servizio UKRP continuativo.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Supporto opzionale per la transizione da CE a UKCA<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">ALTRION pu\u00f2 inoltre fornire <\/span><b>supporto opzionale<\/b><span style=\"font-weight: 400;\"> per la <\/span><b>transizione dalla marcatura CE alla marcatura UKCA<\/b><span style=\"font-weight: 400;\">, inclusi aggiornamenti UDI e di etichettatura in previsione di futuri cambiamenti regolatori MHRA.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Questo servizio \u00e8 pensato per i fabbricanti che devono prepararsi per <\/span><b>requisiti di accesso al mercato UK in evoluzione<\/b><span style=\"font-weight: 400;\"> mantenendo il controllo sulla documentazione tecnica, l&#8217;etichettatura e i dati regolatori.<\/span><\/p>\n<\/div>\n<\/div>\n<\/div><\/section><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mqrwe7ku-9cea5ac8f12e3c3875e60ed3b55a2230\">\n.avia-section.av-mqrwe7ku-9cea5ac8f12e3c3875e60ed3b55a2230{\nbackground-color:#ffffff;\nbackground-image:unset;\n}\n<\/style>\n<div id='av_section_4'  class='avia-section av-mqrwe7ku-9cea5ac8f12e3c3875e60ed3b55a2230 main_color avia-section-default avia-no-border-styling avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-3095'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_four_fifth-6ed62927e07929c2f4f5c8529e712d7c\">\n.flex_column.av-av_four_fifth-6ed62927e07929c2f4f5c8529e712d7c{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-av_four_fifth-6ed62927e07929c2f4f5c8529e712d7c av_four_fifth first flex_column_div av-zero-column-padding  '     ><section  class='av_textblock_section av-mq6rmmr3-2501fc37f190548006c233dcf7ea66e7 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><h2><span style=\"font-weight: 400;\">FAQ sul UKRP<\/span><\/h2>\n<\/div><\/section><br \/>\n<div  class='togglecontainer av-mq6rm91g-eacdde23200196960c2668b78ef940fa toggle_close_all' >\n<section class='av_toggle_section av-mq6rktvy-425d63a586393b00aec45a6a9ad8ad96'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{Tutto} \"  ><p id='toggle-toggle-id-1' data-fake-id='#toggle-id-1' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-1' data-slide-speed=\"200\" data-title=\"Cos&amp;apos;\u00e8 un UKRP?\" data-title-open=\"\" data-aria_collapsed=\"Clicca per espandere: Cos&amp;apos;\u00e8 un UKRP?\" data-aria_expanded=\"Fare clic per chiudere: Cos&amp;apos;\u00e8 un UKRP?\">Cos&apos;\u00e8 un UKRP?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-1' aria-labelledby='toggle-toggle-id-1' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p><span style=\"font-weight: 400;\">Un UKRP, o UK Responsible Person, \u00e8 il rappresentante ufficiale nominato da un fabbricante extra-UK per agire presso l&#8217;MHRA per i dispositivi medici o gli IVD immessi nel mercato della Gran Bretagna.<\/span><\/p>\n<p><br style=\"font-weight: 400;\" \/><br style=\"font-weight: 400;\" \/><\/p>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-mq6rl5xn-31b31c36a35d856d00ef36ae1a078853'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{Tutto} \"  ><p id='toggle-toggle-id-2' data-fake-id='#toggle-id-2' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-2' data-slide-speed=\"200\" data-title=\"Chi necessita di un UK Responsible Person?\" data-title-open=\"\" data-aria_collapsed=\"Clicca per espandere: Chi necessita di un UK Responsible Person?\" data-aria_expanded=\"Fare clic per chiudere: Chi necessita di un UK Responsible Person?\">Chi necessita di un UK Responsible Person?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-2' aria-labelledby='toggle-toggle-id-2' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p><span style=\"font-weight: 400;\">I fabbricanti extra-UK che desiderano immettere dispositivi medici o dispositivi diagnostici in vitro nel mercato della Gran Bretagna devono nominare un UK Responsible Person ai sensi del UK MDR 2002, come modificato.<\/span><\/p>\n<p><br style=\"font-weight: 400;\" \/><br style=\"font-weight: 400;\" \/><\/p>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-mq6rlihj-4ed54740c7ddbf5f999aa9f03442fdf5'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{Tutto} \"  ><p id='toggle-toggle-id-3' data-fake-id='#toggle-id-3' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-3' data-slide-speed=\"200\" data-title=\"Cosa fa ALTRION come UKRP?\" data-title-open=\"\" data-aria_collapsed=\"Clicca per espandere: Cosa fa ALTRION come UKRP?\" data-aria_expanded=\"Fare clic per chiudere: Cosa fa ALTRION come UKRP?\">Cosa fa ALTRION come UKRP?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-3' aria-labelledby='toggle-toggle-id-3' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p><span style=\"font-weight: 400;\">ALTRION supporta la nomina del UKRP, la registrazione MHRA, la gestione della registrazione DORS, la verifica della documentazione tecnica, la conformit\u00e0 dell&#8217;etichettatura, il coordinamento della vigilanza, il reporting PMS e la comunicazione con l&#8217;MHRA.<\/span><\/p>\n<p><br style=\"font-weight: 400;\" \/><br style=\"font-weight: 400;\" \/><\/p>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-mq6rlv46-c90bd3f266055fd1c55c73c7cf9f380b'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{Tutto} \"  ><p id='toggle-toggle-id-4' data-fake-id='#toggle-id-4' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-4' data-slide-speed=\"200\" data-title=\"Cos&amp;apos;\u00e8 l&amp;apos;MHRA DORS?\" data-title-open=\"\" data-aria_collapsed=\"Clicca per espandere: Cos&amp;apos;\u00e8 l&amp;apos;MHRA DORS?\" data-aria_expanded=\"Fare clic per chiudere: Cos&amp;apos;\u00e8 l&amp;apos;MHRA DORS?\">Cos&apos;\u00e8 l&apos;MHRA DORS?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-4' aria-labelledby='toggle-toggle-id-4' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p><span style=\"font-weight: 400;\">DORS is the MHRA Device Online Registration System. ALTRION gestisce le registration activities in DORS and supports proof of device listing for manufacturers placing devices on the Great Britain market.<\/span><\/p>\n<p><br style=\"font-weight: 400;\" \/><br style=\"font-weight: 400;\" \/><\/p>\n<\/div><\/div><\/div><\/section>\n<section class='av_toggle_section av-mq6rm7r3-9eebd55aa17864f1897fc08fc76dba63'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div role=\"tablist\" class=\"single_toggle\" data-tags=\"{Tutto} \"  ><p id='toggle-toggle-id-5' data-fake-id='#toggle-id-5' class='toggler  av-title-above '  itemprop=\"headline\"  role='tab' tabindex='0' aria-controls='toggle-id-5' data-slide-speed=\"200\" data-title=\"Il supporto UKRP include la conformit\u00e0 post-market?\" data-title-open=\"\" data-aria_collapsed=\"Clicca per espandere: Il supporto UKRP include la conformit\u00e0 post-market?\" data-aria_expanded=\"Fare clic per chiudere: Il supporto UKRP include la conformit\u00e0 post-market?\">Il supporto UKRP include la conformit\u00e0 post-market?<span class=\"toggle_icon\"><span class=\"vert_icon\"><\/span><span class=\"hor_icon\"><\/span><\/span><\/p><div id='toggle-id-5' aria-labelledby='toggle-toggle-id-5' role='region' class='toggle_wrap  av-title-above'  ><div class='toggle_content invers-color '  itemprop=\"text\" ><p><span style=\"font-weight: 400;\">S\u00ec. ALTRION supporta il coordinamento della vigilanza, il reporting PMS, i report su incidenti gravi, la presentazione di FSCA, la verifica annuale di conformit\u00e0 e la comunicazione continua con l&#8217;MHRA.<\/span><\/p>\n<p><br style=\"font-weight: 400;\" \/><br style=\"font-weight: 400;\" \/><\/p>\n<\/div><\/div><\/div><\/section>\n<\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-mq6rn9z9-253bcf846e61e421f236dafcc89decca\">\n#top .hr.hr-invisible.av-mq6rn9z9-253bcf846e61e421f236dafcc89decca{\nheight:100px;\n}\n<\/style>\n<div  class='hr av-mq6rn9z9-253bcf846e61e421f236dafcc89decca hr-invisible'><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n<section  class='av_textblock_section av-mq6rmxho-f7b1fecf53046c39037b06c2b9adeccf '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><h2><span style=\"font-weight: 400;\">Perch\u00e9 scegliere ALTRION<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">ALTRION fornisce la <\/span><b>presenza legale diretta nel Regno Unito<\/b><span style=\"font-weight: 400;\"> attraverso il proprio <\/span><b>ufficio con sede a Londra<\/b><span style=\"font-weight: 400;\">, offrendo ai fabbricanti extra-UK un <\/span><b>rappresentante locale affidabile<\/b><span style=\"font-weight: 400;\"> per l&#8217;accesso al mercato della Gran Bretagna. Il team regolatorio \u00e8 esperto in conformit\u00e0 UK MDR 2002 e nella transizione di mercato post-Brexit, con una <\/span><b>comprensione approfondita dei flussi di lavoro della registrazione MHRA<\/b><span style=\"font-weight: 400;\">, audit e protocolli di vigilanza. ALTRION offre inoltre un <\/span><b>coordinamento integrato con i propri uffici EU-REP e CH-REP<\/b><span style=\"font-weight: 400;\"> per i fabbricanti che operano in pi\u00f9 giurisdizioni. I contratti sono trasparenti e flessibili, tipicamente validi per cinque anni, rinnovabili annualmente e senza costi nascosti. ALTRION fa parte di una <\/span><b>rete di rappresentanza globale<\/b><span style=\"font-weight: 400;\"> che copre UE, Svizzera, UK e USA.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Documentazione fornita<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">ALTRION fornisce gli <\/span><b>output regolatori chiave<\/b><span style=\"font-weight: 400;\"> necessari per formalizzare la nomina del UKRP, supportare la registrazione MHRA e mantenere la conformit\u00e0 continua in Gran Bretagna.<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Accordo di servizio UKRP e Lettera di designazione, conforme al Regulation 7A del UK MDR 2002.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Conferma di registrazione MHRA e prova di listing del dispositivo nel database DORS.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Dettagli di contatto per l&#8217;inclusione su etichettatura e Istruzioni per l&#8217;Uso (IFU).<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Riepilogo annuale PMS e vigilanza, incluso un registro delle comunicazioni MHRA.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Supporto continuo per rinnovi delle registrazioni, modifiche e aggiornamenti di conformit\u00e0.<\/span><\/li>\n<\/ul>\n<\/div><\/section><\/p><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av-layout-grid-2'  class='av-layout-grid-container av-2m8rml-cf1550da75c0a23f15e912f47bff0540 entry-content-wrapper main_color av-flex-cells  avia-builder-el-18  el_after_av_section  avia-builder-el-last  av-cell-min-height av-cell-min-height-25 grid-row-not-first  container_wrap fullsize'   data-av_minimum_height_pc='25'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2c9gfx-e7c714a2c4eecf09731b0ce122b582ff\">\n.flex_cell.av-2c9gfx-e7c714a2c4eecf09731b0ce122b582ff{\nvertical-align:middle;\nbackground-color:#22689e;\n}\n.responsive #top #wrap_all .flex_cell.av-2c9gfx-e7c714a2c4eecf09731b0ce122b582ff{\npadding:50px 50px 50px 50px !important;\n}\n<\/style>\n<div class='flex_cell av-2c9gfx-e7c714a2c4eecf09731b0ce122b582ff av-gridrow-cell av_one_half no_margin  avia-builder-el-19  el_before_av_cell_one_half  avia-builder-el-first  content-align-middle avia-full-stretch'  ><div class='flex_cell_inner'><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kguz1-0e07de2699c382e8f4519fcf6ad95912\">\n#top .av-special-heading.av-kguz1-0e07de2699c382e8f4519fcf6ad95912{\npadding-bottom:10px;\ncolor:#ffffff;\nfont-size:34px;\n}\nbody .av-special-heading.av-kguz1-0e07de2699c382e8f4519fcf6ad95912 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n#top #wrap_all .av-special-heading.av-kguz1-0e07de2699c382e8f4519fcf6ad95912 .av-special-heading-tag{\nfont-size:34px;\n}\n.av-special-heading.av-kguz1-0e07de2699c382e8f4519fcf6ad95912 .special-heading-inner-border{\nborder-color:#ffffff;\n}\n.av-special-heading.av-kguz1-0e07de2699c382e8f4519fcf6ad95912 .av-subheading{\nfont-size:15px;\n}\n\n@media only screen and (min-width: 480px) and (max-width: 767px){ \n#top #wrap_all .av-special-heading.av-kguz1-0e07de2699c382e8f4519fcf6ad95912 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n\n@media only screen and (max-width: 479px){ \n#top #wrap_all .av-special-heading.av-kguz1-0e07de2699c382e8f4519fcf6ad95912 .av-special-heading-tag{\nfont-size:0.8em;\n}\n}\n<\/style>\n<div  class='av-special-heading av-kguz1-0e07de2699c382e8f4519fcf6ad95912 av-special-heading-h2 custom-color-heading blockquote modern-quote modern-centered  avia-builder-el-20  el_before_av_hr  avia-builder-el-first  av-thin-font av-inherit-size'><h2 class='av-special-heading-tag '  itemprop=\"headline\"  ><strong>Cerchi un UKRP per dispositivi medici?<br \/>\nSiamo qui per assisterti!<\/strong><\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-1k8np-a31b6b6b6f0cf69477c7c37e741a2466\">\n#top .hr.av-1k8np-a31b6b6b6f0cf69477c7c37e741a2466{\nmargin-top:10px;\nmargin-bottom:10px;\n}\n.hr.av-1k8np-a31b6b6b6f0cf69477c7c37e741a2466 .hr-inner{\nwidth:50px;\nborder-color:#ffffff;\n}\n<\/style>\n<div  class='hr av-1k8np-a31b6b6b6f0cf69477c7c37e741a2466 hr-custom  avia-builder-el-21  el_after_av_heading  el_before_av_textblock  hr-center hr-icon-no'><span class='hr-inner inner-border-av-border-fat'><span class=\"hr-inner-style\"><\/span><\/span><\/div><br \/>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-aasqd-2f8a1807401651b6db6544716e41dc17\">\n#top .av_textblock_section.av-aasqd-2f8a1807401651b6db6544716e41dc17 .avia_textblock{\ncolor:#ffffff;\n}\n<\/style>\n<section  class='av_textblock_section av-aasqd-2f8a1807401651b6db6544716e41dc17 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><p style=\"text-align: center;\">Compila il modulo con la tua richiesta.<\/p>\n<p style=\"text-align: center;\">Ti contatteremo il prima possibile.<\/p>\n<\/div><\/section><\/p>\n<\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2aze9h-e7d67b752f4c05a190c3bec726a2b11c\">\n.flex_cell.av-2aze9h-e7d67b752f4c05a190c3bec726a2b11c{\nvertical-align:middle;\nbackground:url(https:\/\/altrion-group.com\/wp-content\/uploads\/2023\/01\/corporate-buildings-m-1030x687-_1_.webp) 0% 0% no-repeat scroll #22689e;\n}\n.responsive #top #wrap_all .flex_cell.av-2aze9h-e7d67b752f4c05a190c3bec726a2b11c{\npadding:30px 30px 30px 30px !important;\n}\n<\/style>\n<div class='flex_cell av-2aze9h-e7d67b752f4c05a190c3bec726a2b11c av-gridrow-cell av_one_half no_margin  avia-builder-el-23  el_after_av_cell_one_half  avia-builder-el-last  content-align-middle avia-full-stretch'  ><div class='flex_cell_inner'>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lampn59y-16cdac81044de464c165dfce7cd51d9e\">\n.flex_column.av-lampn59y-16cdac81044de464c165dfce7cd51d9e{\npadding:20px 20px 20px 20px;\nbackground-color:#bfd6e6;\n}\n<\/style>\n<div  id=\"modulo-contatto\"  class='flex_column av-lampn59y-16cdac81044de464c165dfce7cd51d9e av_four_fifth  avia-builder-el-24  avia-builder-el-no-sibling  first flex_column_div  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-lamq769l-6198ca162e9bf78457dec726ab2c95de\">\n#top .av_textblock_section.av-lamq769l-6198ca162e9bf78457dec726ab2c95de .avia_textblock{\ncolor:#ffffff;\n}\n<\/style>\n<section  class='av_textblock_section av-lamq769l-6198ca162e9bf78457dec726ab2c95de '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock av_inherit_color'  itemprop=\"text\" ><h3 style=\"text-align: center;\"><strong>Form di contatto<\/strong><\/h3>\n<\/div><\/section><br \/>\n<form action=\"https:\/\/altrion-group.com\/it\/uk-rp-dispositivi-medici\/\" method=\"post\" data-fields-with-error=\"Sono stati riscontrati errori nei seguenti campi:\" class=\"avia_ajax_form av-form-labels-hidden   avia-builder-el-26  el_after_av_textblock  avia-builder-el-last   \" data-avia-form-id=\"1\" data-avia-redirect='https:\/\/altrion-group.com\/it\/messaggio-inviato\/' ><fieldset><p class='  first_form  form_element form_fullwidth' id='element_avia_1_1'><label for=\"avia_1_1\">Nome e Cognome <abbr class=\"required\" title=\"richiesto\">*<\/abbr><\/label> <input name=\"avia_1_1\" class=\"text_input is_empty\" type=\"text\" id=\"avia_1_1\" value=\"\"  placeholder='Nome e Cognome*'\/><\/p><p class='  first_form  form_element form_element_half' id='element_avia_2_1'><label for=\"avia_2_1\">Azienda <abbr class=\"required\" title=\"richiesto\">*<\/abbr><\/label> <input name=\"avia_2_1\" class=\"text_input is_empty\" type=\"text\" id=\"avia_2_1\" value=\"\"  placeholder='Azienda*'\/><\/p><p class='  form_element form_element_half' id='element_avia_3_1'><label for=\"avia_3_1\">Citt\u00e0 <abbr class=\"required\" title=\"richiesto\">*<\/abbr><\/label> <input name=\"avia_3_1\" class=\"text_input is_empty\" type=\"text\" id=\"avia_3_1\" value=\"\"  placeholder='Citt\u00e0*'\/><\/p><p class='  first_form  form_element form_element_half' id='element_avia_4_1'><label for=\"avia_4_1\">E-Mail <abbr class=\"required\" title=\"richiesto\">*<\/abbr><\/label> <input name=\"avia_4_1\" class=\"text_input is_email\" type=\"text\" id=\"avia_4_1\" value=\"\"  placeholder='E-Mail*'\/><\/p><p class='  form_element form_element_half' id='element_avia_5_1'><label for=\"avia_5_1\">Telefono<\/label> <input name=\"avia_5_1\" class=\"text_input \" type=\"text\" id=\"avia_5_1\" value=\"\"  placeholder='Telefono'\/><\/p><p class='  first_form  form_element form_fullwidth' id='element_avia_6_1'><label for=\"avia_6_1\" class=\"textare_label hidden textare_label_avia_6_1\">Scrivi qui la tua richiesta <abbr class=\"required\" title=\"richiesto\">*<\/abbr><\/label><textarea  placeholder='Scrivi qui la tua richiesta*' name=\"avia_6_1\" class=\"text_area is_empty\" cols=\"40\" rows=\"7\" id=\"avia_6_1\" ><\/textarea><\/p><p class=\"hidden\"><input type=\"text\" name=\"avia_7_1\" class=\"hidden \" id=\"avia_7_1\" value=\"\" \/><\/p><div id='avia_8_1' class='av-recaptcha-area  first_form  form_element form_fullwidth '  data-container_class=\"\" data-custom_class=\"\" data-context=\"av_contact_form\" data-token_input=\"av_recaptcha_token\" data-version=\"avia_recaptcha_v2\" data-theme=\"light\" data-size=\"normal\" 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