{"id":18552,"date":"2022-05-03T00:20:53","date_gmt":"2022-05-02T23:20:53","guid":{"rendered":"https:\/\/test.merieuxnutrisciences.com\/?page_id=18552"},"modified":"2025-11-13T19:07:35","modified_gmt":"2025-11-13T19:07:35","slug":"servicos-para-dispositivos-medicos","status":"publish","type":"page","link":"https:\/\/www.merieuxnutrisciences.com\/pt\/produtos-farmaceuticos-e-dispositivos-medicos\/dispositivos-medicos\/servicos-para-dispositivos-medicos\/","title":{"rendered":"Servi\u00e7os para dispositivos m\u00e9dicos"},"content":{"rendered":"\n<div class=\"page-header-block-wrapper fullwidth-block\">\n    <div class=\"acf-page-header\" style=\"background-image: url('https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2022\/05\/medical-devices.png'); \">\n        <div class=\"overlay\"><\/div>\n        <div class=\"acf-page-header-container\">\n                        <h1>Servi\u00e7os para dispositivos m\u00e9dicos<\/h1>\n        <\/div>\n    <\/div>\n<\/div>\n\n<style>\n.page-header-block-wrapper{\n    margin-bottom: 60px;\n}\n\n.fullwidth-block {\n    max-width: none !important;\n    width: 100vw !important;\n    position: relative;\n    padding:0px;\n    left: 50%;\n    right: 50%;\n    margin-left: -50vw;\n    margin-right: -50vw;\n}\n\n.acf-page-header {\n    background-size: cover;\n    background-position: center;\n    display: flex;\n    position: relative;\n    min-height: 250px; \n}\n\n.acf-page-header-container{\n    margin: 0 auto;\n    padding: 48px 24px;\n    display: flex;\n    flex-direction: column;\n    justify-content: end;\n    align-items: center;\n}\n\n.acf-page-header .overlay {\n    position: absolute;\n    top: 0;\n    left: 0;\n    right: 0;\n    bottom: 0;\n    background: linear-gradient(to top, var(--global-palette4), transparent);\n    z-index: 1;\n}\n\n.acf-page-header-container .image-wrapper{\n    position:relative;\n    height: 70px;\n    width: 70px;\n    background: var(--global-palette4);\n    border-radius: 50%;\n    z-index: 1;\n}\n\n.acf-page-header-container img{\n    position: absolute;\n    top: 50%;\n    left: 50%;\n    transform: translate(-50%, -50%);\n    max-width:40px;\n    z-index: 2;\n}\n\n.acf-page-header h1 {\n    display:block;\n    position: relative;\n    z-index: 2;\n    color:white;\n    text-align: center;\n}\n\n@media (min-width: 1025px) {\n    .acf-page-header-container{\n        width: 1290px;\n    }\n    \n}\n\n@media (max-width: 1024px) {\n    .acf-page-header-container {\n        align-self: end;\n    }\n    .acf-page-header .overlay {\n        background: linear-gradient(to top, var(--global-palette4), transparent);\n    }\n}\n\n@media (max-width: 768px) {\n    .acf-page-header .overlay {\n        background: linear-gradient(to top, var(--global-palette4), transparent);\n    }\n    .acf-page-header h1 {\n        font-size:28px;\n    }\n}\n\n<\/style>\n\n\n\n<style>.wp-block-kadence-advancedheading.kt-adv-heading18552_96f24b-db, .wp-block-kadence-advancedheading.kt-adv-heading18552_96f24b-db[data-kb-block=\"kb-adv-heading18552_96f24b-db\"]{font-style:normal;}.wp-block-kadence-advancedheading.kt-adv-heading18552_96f24b-db mark.kt-highlight, .wp-block-kadence-advancedheading.kt-adv-heading18552_96f24b-db[data-kb-block=\"kb-adv-heading18552_96f24b-db\"] mark.kt-highlight{font-style:normal;color:#f76a0c;-webkit-box-decoration-break:clone;box-decoration-break:clone;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}.wp-block-kadence-advancedheading.kt-adv-heading18552_96f24b-db img.kb-inline-image, .wp-block-kadence-advancedheading.kt-adv-heading18552_96f24b-db[data-kb-block=\"kb-adv-heading18552_96f24b-db\"] img.kb-inline-image{width:150px;vertical-align:baseline;}<\/style>\n<h2 class=\"kt-adv-heading18552_96f24b-db wp-block-kadence-advancedheading\" data-kb-block=\"kb-adv-heading18552_96f24b-db\"><strong><strong>Solu\u00e7\u00f5es inovadoras para o setor da sa\u00fade<\/strong><\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">O <strong><a href=\"http:\/\/data.europa.eu\/eli\/reg\/2017\/745\/oj\" target=\"_blank\" data-type=\"link\" data-id=\"http:\/\/data.europa.eu\/eli\/reg\/2017\/745\/oj\" rel=\"noreferrer noopener\"><a href=\"about:blank\">Regulamento 745\/2017<\/a><\/a> <\/strong>define como <strong>Dispositivo M\u00e9dico<\/strong> qualquer instrumento, aparelho, equipamento, software, implante, reagente, material ou outro artigo, destinado pelo fabricante a ser empregue em seres humanos, sozinho ou em combina\u00e7\u00e3o, para uma ou mais finalidades m\u00e9dicas espec\u00edficas.<\/p>\n\n\n<style>.wp-block-kadence-advancedheading.kt-adv-heading18552_8374cd-a3, .wp-block-kadence-advancedheading.kt-adv-heading18552_8374cd-a3[data-kb-block=\"kb-adv-heading18552_8374cd-a3\"]{font-style:normal;}.wp-block-kadence-advancedheading.kt-adv-heading18552_8374cd-a3 mark.kt-highlight, .wp-block-kadence-advancedheading.kt-adv-heading18552_8374cd-a3[data-kb-block=\"kb-adv-heading18552_8374cd-a3\"] mark.kt-highlight{font-style:normal;color:#f76a0c;-webkit-box-decoration-break:clone;box-decoration-break:clone;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}.wp-block-kadence-advancedheading.kt-adv-heading18552_8374cd-a3 img.kb-inline-image, .wp-block-kadence-advancedheading.kt-adv-heading18552_8374cd-a3[data-kb-block=\"kb-adv-heading18552_8374cd-a3\"] img.kb-inline-image{width:150px;vertical-align:baseline;}<\/style>\n<h2 class=\"kt-adv-heading18552_8374cd-a3 wp-block-kadence-advancedheading\" data-kb-block=\"kb-adv-heading18552_8374cd-a3\"><strong>O Regulamento (UE) 2017\/745<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">O Regulamento aplica-se desde 26 de maio de 2021, ap\u00f3s um per\u00edodo de transi\u00e7\u00e3o de quatro anos, pelo que os fabricantes que tenham introduzido novos dispositivos m\u00e9dicos no mercado a partir dessa data dever\u00e3o cumprir as disposi\u00e7\u00f5es presentes no <em>Medical Device Regulation <\/em>(MDR).<\/p>\n\n\n<style>.wp-block-kadence-advancedheading.kt-adv-heading18552_006095-5d, .wp-block-kadence-advancedheading.kt-adv-heading18552_006095-5d[data-kb-block=\"kb-adv-heading18552_006095-5d\"]{font-style:normal;}.wp-block-kadence-advancedheading.kt-adv-heading18552_006095-5d mark.kt-highlight, .wp-block-kadence-advancedheading.kt-adv-heading18552_006095-5d[data-kb-block=\"kb-adv-heading18552_006095-5d\"] mark.kt-highlight{font-style:normal;color:#f76a0c;-webkit-box-decoration-break:clone;box-decoration-break:clone;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}.wp-block-kadence-advancedheading.kt-adv-heading18552_006095-5d img.kb-inline-image, .wp-block-kadence-advancedheading.kt-adv-heading18552_006095-5d[data-kb-block=\"kb-adv-heading18552_006095-5d\"] img.kb-inline-image{width:150px;vertical-align:baseline;}<\/style>\n<h2 class=\"kt-adv-heading18552_006095-5d wp-block-kadence-advancedheading\" data-kb-block=\"kb-adv-heading18552_006095-5d\"><strong><strong>Classifica\u00e7\u00e3o dos dispositivos m\u00e9dicos<\/strong><\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Para uma classifica\u00e7\u00e3o correta dos Dispositivos m\u00e9dicos, \u00e9 oportuno verificar a finalidade de uso e o mecanismo de a\u00e7\u00e3o.\u00a0<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Os Dispositivos m\u00e9dicos s\u00e3o classificados em classes de risco dependendo da dura\u00e7\u00e3o, modo e tipo de intera\u00e7\u00e3o com o corpo:<\/p>\n\n\n<style>.kt-accordion-id18552_5781bd-aa .kt-accordion-inner-wrap{column-gap:var(--global-kb-gap-md, 2rem);row-gap:0px;}.kt-accordion-id18552_5781bd-aa .kt-accordion-panel-inner{border-top:0px solid transparent;border-right:0px solid transparent;border-bottom:0px solid transparent;border-left:0px solid transparent;padding-top:var(--global-kb-spacing-sm, 1.5rem);padding-right:var(--global-kb-spacing-sm, 1.5rem);padding-bottom:var(--global-kb-spacing-sm, 1.5rem);padding-left:var(--global-kb-spacing-sm, 1.5rem);}.kt-accordion-id18552_5781bd-aa > .kt-accordion-inner-wrap > .wp-block-kadence-pane > .kt-accordion-header-wrap > .kt-blocks-accordion-header{border-top:1px solid #f2f2f2;border-right:1px solid #f2f2f2;border-bottom:1px solid #f2f2f2;border-left:1px solid #f2f2f2;border-top-left-radius:0px;border-top-right-radius:0px;border-bottom-right-radius:0px;border-bottom-left-radius:0px;background:#f2f2f2;color:#555555;padding-top:9px;padding-right:13px;padding-bottom:9px;padding-left:13px;}.kt-accordion-id18552_5781bd-aa:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle )  > .kt-accordion-inner-wrap > .wp-block-kadence-pane > .kt-accordion-header-wrap .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id18552_5781bd-aa:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle )  > .kt-accordion-inner-wrap > .wp-block-kadence-pane > .kt-accordion-header-wrap .kt-blocks-accordion-icon-trigger:before{background:#555555;}.kt-accordion-id18552_5781bd-aa:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-icon-trigger{background:#555555;}.kt-accordion-id18552_5781bd-aa:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id18552_5781bd-aa:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-icon-trigger:before{background:#f2f2f2;}.kt-accordion-id18552_5781bd-aa > .kt-accordion-inner-wrap > .wp-block-kadence-pane > .kt-accordion-header-wrap > .kt-blocks-accordion-header:hover, \n\t\t\t\tbody:not(.hide-focus-outline) .kt-accordion-id18552_5781bd-aa .kt-blocks-accordion-header:focus-visible{color:#444444;background:#eeeeee;border-top:1px solid #878787;border-right:1px solid #878787;border-bottom:1px solid #878787;border-left:1px solid #878787;}.kt-accordion-id18552_5781bd-aa:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-accordion-header-wrap .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id18552_5781bd-aa:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-accordion-header-wrap .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:before, body:not(.hide-focus-outline) .kt-accordion-id18552_5781bd-aa:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion--visible .kt-blocks-accordion-icon-trigger:after, body:not(.hide-focus-outline) .kt-accordion-id18552_5781bd-aa:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger:before{background:#444444;}.kt-accordion-id18552_5781bd-aa:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-accordion-header-wrap .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger, body:not(.hide-focus-outline) .kt-accordion-id18552_5781bd-aa:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger{background:#444444;}.kt-accordion-id18552_5781bd-aa:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-accordion-header-wrap .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id18552_5781bd-aa:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-accordion-header-wrap .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:before, body:not(.hide-focus-outline) .kt-accordion-id18552_5781bd-aa:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger:after, body:not(.hide-focus-outline) .kt-accordion-id18552_5781bd-aa:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger:before{background:#eeeeee;}.kt-accordion-id18552_5781bd-aa .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible,\n\t\t\t\t.kt-accordion-id18552_5781bd-aa > .kt-accordion-inner-wrap > .wp-block-kadence-pane > .kt-accordion-header-wrap > .kt-blocks-accordion-header.kt-accordion-panel-active{color:#ffffff;background:#444444;border-top:1px solid #444444;border-right:1px solid #444444;border-bottom:1px solid #444444;border-left:1px solid #444444;}.kt-accordion-id18552_5781bd-aa:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle )  > .kt-accordion-inner-wrap > .wp-block-kadence-pane > .kt-accordion-header-wrap > .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id18552_5781bd-aa:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle )  > .kt-accordion-inner-wrap > .wp-block-kadence-pane > .kt-accordion-header-wrap > .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:before{background:#ffffff;}.kt-accordion-id18552_5781bd-aa:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger{background:#ffffff;}.kt-accordion-id18552_5781bd-aa:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id18552_5781bd-aa:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:before{background:#444444;}@media all and (max-width: 1024px){.kt-accordion-id18552_5781bd-aa .kt-accordion-panel-inner{border-top:0px solid transparent;border-right:0px solid transparent;border-bottom:0px solid transparent;border-left:0px solid transparent;}}@media all and (max-width: 1024px){.kt-accordion-id18552_5781bd-aa > .kt-accordion-inner-wrap > .wp-block-kadence-pane > .kt-accordion-header-wrap > .kt-blocks-accordion-header{border-top:1px solid #f2f2f2;border-right:1px solid #f2f2f2;border-bottom:1px solid #f2f2f2;border-left:1px solid #f2f2f2;}}@media all and (max-width: 1024px){.kt-accordion-id18552_5781bd-aa > .kt-accordion-inner-wrap > .wp-block-kadence-pane > .kt-accordion-header-wrap > .kt-blocks-accordion-header:hover, \n\t\t\t\tbody:not(.hide-focus-outline) .kt-accordion-id18552_5781bd-aa .kt-blocks-accordion-header:focus-visible{border-top:1px solid #878787;border-right:1px solid #878787;border-bottom:1px solid #878787;border-left:1px solid #878787;}}@media all and (max-width: 1024px){.kt-accordion-id18552_5781bd-aa .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible,\n\t\t\t\t.kt-accordion-id18552_5781bd-aa > .kt-accordion-inner-wrap > .wp-block-kadence-pane > .kt-accordion-header-wrap > .kt-blocks-accordion-header.kt-accordion-panel-active{border-top:1px solid #444444;border-right:1px solid #444444;border-bottom:1px solid #444444;border-left:1px solid #444444;}}@media all and (max-width: 767px){.kt-accordion-id18552_5781bd-aa .kt-accordion-inner-wrap{display:block;}.kt-accordion-id18552_5781bd-aa .kt-accordion-inner-wrap .kt-accordion-pane:not(:first-child){margin-top:0px;}.kt-accordion-id18552_5781bd-aa .kt-accordion-panel-inner{border-top:0px solid transparent;border-right:0px solid transparent;border-bottom:0px solid transparent;border-left:0px solid transparent;}.kt-accordion-id18552_5781bd-aa > .kt-accordion-inner-wrap > .wp-block-kadence-pane > .kt-accordion-header-wrap > .kt-blocks-accordion-header{border-top:1px solid #f2f2f2;border-right:1px solid #f2f2f2;border-bottom:1px solid #f2f2f2;border-left:1px solid #f2f2f2;}.kt-accordion-id18552_5781bd-aa > .kt-accordion-inner-wrap > .wp-block-kadence-pane > .kt-accordion-header-wrap > .kt-blocks-accordion-header:hover, \n\t\t\t\tbody:not(.hide-focus-outline) .kt-accordion-id18552_5781bd-aa .kt-blocks-accordion-header:focus-visible{border-top:1px solid #878787;border-right:1px solid #878787;border-bottom:1px solid #878787;border-left:1px solid #878787;}.kt-accordion-id18552_5781bd-aa .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible,\n\t\t\t\t.kt-accordion-id18552_5781bd-aa > .kt-accordion-inner-wrap > .wp-block-kadence-pane > .kt-accordion-header-wrap > .kt-blocks-accordion-header.kt-accordion-panel-active{border-top:1px solid #444444;border-right:1px solid #444444;border-bottom:1px solid #444444;border-left:1px solid #444444;}}<\/style>\n<div class=\"wp-block-kadence-accordion alignnone\"><div class=\"kt-accordion-wrap kt-accordion-id18552_5781bd-aa kt-accordion-has-3-panes kt-active-pane-0 kt-accordion-block kt-pane-header-alignment-left kt-accodion-icon-style-basic kt-accodion-icon-side-right\" style=\"max-width:none\"><div class=\"kt-accordion-inner-wrap\" data-allow-multiple-open=\"false\" data-start-open=\"none\">\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-1 kt-pane18552_29d5ca-78\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\"><strong>Classe I\u00a0<\/strong><\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<p class=\"wp-block-paragraph\"><strong>CLASSE I<\/strong> (com subclasses: I est\u00e9ril ou tamanho I): todos os dispositivos n\u00e3o invasivos com algumas exce\u00e7\u00f5es para os instrumentos cir\u00fargicos e para dispositivos invasivos em rela\u00e7\u00e3o com os orif\u00edcios do corpo \u2013 risco mais baixo.<\/p>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-2 kt-pane18552_18d1cf-af\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\"><strong>Classe II<\/strong><\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<p class=\"wp-block-paragraph\"><strong>CLASSE II<\/strong> (com subclasses IIa e IIb): dispositivos invasivos em rela\u00e7\u00e3o com os orif\u00edcios do corpo e de tipo cir\u00fargico, e dispositivos \u00e0 base de subst\u00e2ncia.<\/p>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-3 kt-pane18552_a2c36d-f5\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\"><strong>Classe III<\/strong><\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<p class=\"wp-block-paragraph\"><strong>CLASSE III<\/strong>: dispositivos invasivos de tipo cir\u00fargico e dispositivos \u00e0 base de subst\u00e2ncia.<\/p>\n<\/div><\/div><\/div>\n<\/div><\/div><\/div>\n\n\n<style>.wp-block-kadence-spacer.kt-block-spacer-18552_4a9fcc-7e .kt-block-spacer{height:60px;}.wp-block-kadence-spacer.kt-block-spacer-18552_4a9fcc-7e .kt-divider{border-top-width:1px;height:1px;border-top-color:#eee;width:80%;border-top-style:solid;}<\/style>\n<div class=\"wp-block-kadence-spacer aligncenter kt-block-spacer-18552_4a9fcc-7e\"><div class=\"kt-block-spacer kt-block-spacer-halign-center\"><\/div><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"main-regulatory-references-for-the-european-market\"><strong><strong>Principais refer\u00eancias<\/strong> <strong>normativas para o mercado europeu<\/strong><\/strong><\/h2>\n\n\n<style>.kt-accordion-id18552_2705c4-49 .kt-accordion-inner-wrap{column-gap:var(--global-kb-gap-md, 2rem);row-gap:0px;}.kt-accordion-id18552_2705c4-49 .kt-accordion-panel-inner{border-top:0px solid transparent;border-right:0px solid transparent;border-bottom:0px solid transparent;border-left:0px solid transparent;padding-top:var(--global-kb-spacing-sm, 1.5rem);padding-right:var(--global-kb-spacing-sm, 1.5rem);padding-bottom:var(--global-kb-spacing-sm, 1.5rem);padding-left:var(--global-kb-spacing-sm, 1.5rem);}.kt-accordion-id18552_2705c4-49 > .kt-accordion-inner-wrap > .wp-block-kadence-pane > .kt-accordion-header-wrap > .kt-blocks-accordion-header{border-top:1px solid #f2f2f2;border-right:1px solid #f2f2f2;border-bottom:1px solid #f2f2f2;border-left:1px solid #f2f2f2;border-top-left-radius:0px;border-top-right-radius:0px;border-bottom-right-radius:0px;border-bottom-left-radius:0px;background:#f2f2f2;color:#555555;padding-top:9px;padding-right:13px;padding-bottom:9px;padding-left:13px;}.kt-accordion-id18552_2705c4-49:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle )  > .kt-accordion-inner-wrap > .wp-block-kadence-pane > .kt-accordion-header-wrap .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id18552_2705c4-49:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle )  > .kt-accordion-inner-wrap > .wp-block-kadence-pane > .kt-accordion-header-wrap .kt-blocks-accordion-icon-trigger:before{background:#555555;}.kt-accordion-id18552_2705c4-49:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-icon-trigger{background:#555555;}.kt-accordion-id18552_2705c4-49:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id18552_2705c4-49:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-icon-trigger:before{background:#f2f2f2;}.kt-accordion-id18552_2705c4-49 > .kt-accordion-inner-wrap > .wp-block-kadence-pane > .kt-accordion-header-wrap > .kt-blocks-accordion-header:hover, \n\t\t\t\tbody:not(.hide-focus-outline) .kt-accordion-id18552_2705c4-49 .kt-blocks-accordion-header:focus-visible{color:#444444;background:#eeeeee;border-top:1px solid #878787;border-right:1px solid #878787;border-bottom:1px solid #878787;border-left:1px solid #878787;}.kt-accordion-id18552_2705c4-49:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-accordion-header-wrap .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id18552_2705c4-49:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-accordion-header-wrap .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:before, body:not(.hide-focus-outline) .kt-accordion-id18552_2705c4-49:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion--visible .kt-blocks-accordion-icon-trigger:after, body:not(.hide-focus-outline) .kt-accordion-id18552_2705c4-49:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle ) .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger:before{background:#444444;}.kt-accordion-id18552_2705c4-49:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-accordion-header-wrap .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger, body:not(.hide-focus-outline) .kt-accordion-id18552_2705c4-49:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger{background:#444444;}.kt-accordion-id18552_2705c4-49:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-accordion-header-wrap .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id18552_2705c4-49:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-accordion-header-wrap .kt-blocks-accordion-header:hover .kt-blocks-accordion-icon-trigger:before, body:not(.hide-focus-outline) .kt-accordion-id18552_2705c4-49:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger:after, body:not(.hide-focus-outline) .kt-accordion-id18552_2705c4-49:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible .kt-blocks-accordion-icon-trigger:before{background:#eeeeee;}.kt-accordion-id18552_2705c4-49 .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible,\n\t\t\t\t.kt-accordion-id18552_2705c4-49 > .kt-accordion-inner-wrap > .wp-block-kadence-pane > .kt-accordion-header-wrap > .kt-blocks-accordion-header.kt-accordion-panel-active{color:#ffffff;background:#444444;border-top:1px solid #444444;border-right:1px solid #444444;border-bottom:1px solid #444444;border-left:1px solid #444444;}.kt-accordion-id18552_2705c4-49:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle )  > .kt-accordion-inner-wrap > .wp-block-kadence-pane > .kt-accordion-header-wrap > .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id18552_2705c4-49:not( .kt-accodion-icon-style-basiccircle ):not( .kt-accodion-icon-style-xclosecircle ):not( .kt-accodion-icon-style-arrowcircle )  > .kt-accordion-inner-wrap > .wp-block-kadence-pane > .kt-accordion-header-wrap > .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:before{background:#ffffff;}.kt-accordion-id18552_2705c4-49:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger{background:#ffffff;}.kt-accordion-id18552_2705c4-49:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:after, .kt-accordion-id18552_2705c4-49:not( .kt-accodion-icon-style-basic ):not( .kt-accodion-icon-style-xclose ):not( .kt-accodion-icon-style-arrow ) .kt-blocks-accordion-header.kt-accordion-panel-active .kt-blocks-accordion-icon-trigger:before{background:#444444;}@media all and (max-width: 1024px){.kt-accordion-id18552_2705c4-49 .kt-accordion-panel-inner{border-top:0px solid transparent;border-right:0px solid transparent;border-bottom:0px solid transparent;border-left:0px solid transparent;}}@media all and (max-width: 1024px){.kt-accordion-id18552_2705c4-49 > .kt-accordion-inner-wrap > .wp-block-kadence-pane > .kt-accordion-header-wrap > .kt-blocks-accordion-header{border-top:1px solid #f2f2f2;border-right:1px solid #f2f2f2;border-bottom:1px solid #f2f2f2;border-left:1px solid #f2f2f2;}}@media all and (max-width: 1024px){.kt-accordion-id18552_2705c4-49 > .kt-accordion-inner-wrap > .wp-block-kadence-pane > .kt-accordion-header-wrap > .kt-blocks-accordion-header:hover, \n\t\t\t\tbody:not(.hide-focus-outline) .kt-accordion-id18552_2705c4-49 .kt-blocks-accordion-header:focus-visible{border-top:1px solid #878787;border-right:1px solid #878787;border-bottom:1px solid #878787;border-left:1px solid #878787;}}@media all and (max-width: 1024px){.kt-accordion-id18552_2705c4-49 .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible,\n\t\t\t\t.kt-accordion-id18552_2705c4-49 > .kt-accordion-inner-wrap > .wp-block-kadence-pane > .kt-accordion-header-wrap > .kt-blocks-accordion-header.kt-accordion-panel-active{border-top:1px solid #444444;border-right:1px solid #444444;border-bottom:1px solid #444444;border-left:1px solid #444444;}}@media all and (max-width: 767px){.kt-accordion-id18552_2705c4-49 .kt-accordion-inner-wrap{display:block;}.kt-accordion-id18552_2705c4-49 .kt-accordion-inner-wrap .kt-accordion-pane:not(:first-child){margin-top:0px;}.kt-accordion-id18552_2705c4-49 .kt-accordion-panel-inner{border-top:0px solid transparent;border-right:0px solid transparent;border-bottom:0px solid transparent;border-left:0px solid transparent;}.kt-accordion-id18552_2705c4-49 > .kt-accordion-inner-wrap > .wp-block-kadence-pane > .kt-accordion-header-wrap > .kt-blocks-accordion-header{border-top:1px solid #f2f2f2;border-right:1px solid #f2f2f2;border-bottom:1px solid #f2f2f2;border-left:1px solid #f2f2f2;}.kt-accordion-id18552_2705c4-49 > .kt-accordion-inner-wrap > .wp-block-kadence-pane > .kt-accordion-header-wrap > .kt-blocks-accordion-header:hover, \n\t\t\t\tbody:not(.hide-focus-outline) .kt-accordion-id18552_2705c4-49 .kt-blocks-accordion-header:focus-visible{border-top:1px solid #878787;border-right:1px solid #878787;border-bottom:1px solid #878787;border-left:1px solid #878787;}.kt-accordion-id18552_2705c4-49 .kt-accordion-header-wrap .kt-blocks-accordion-header:focus-visible,\n\t\t\t\t.kt-accordion-id18552_2705c4-49 > .kt-accordion-inner-wrap > .wp-block-kadence-pane > .kt-accordion-header-wrap > .kt-blocks-accordion-header.kt-accordion-panel-active{border-top:1px solid #444444;border-right:1px solid #444444;border-bottom:1px solid #444444;border-left:1px solid #444444;}}<\/style>\n<div class=\"wp-block-kadence-accordion alignnone\"><div class=\"kt-accordion-wrap kt-accordion-id18552_2705c4-49 kt-accordion-has-9-panes kt-active-pane-0 kt-accordion-block kt-pane-header-alignment-left kt-accodion-icon-style-basic kt-accodion-icon-side-right\" style=\"max-width:none\"><div class=\"kt-accordion-inner-wrap\" data-allow-multiple-open=\"false\" data-start-open=\"none\">\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-1 kt-pane18552_7cdd4c-cd\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\"><strong>Regulamento (UE) 2017\/745<\/strong><\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<p class=\"wp-block-paragraph\"><strong>Regulamento (UE) 2017\/745<\/strong> do Parlamento Europeu e do Conselho, de 5 de abril de 2017, sobre os dispositivos m\u00e9dicos \u2013 altera a diretiva 2001\/83\/CE, o regulamento (CE) n.\u00ba 178\/2002 e o regulamento (CE) n.\u00ba 1223\/2009 e substitui as diretivas do Conselho 90\/385\/CEE e 93\/42\/CEE, a partir de maio de 2021.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Valida\u00e7\u00e3o do reprocessamento de dispositivo m\u00e9dico single-use e reutiliz\u00e1veis.<\/li>\n\n\n\n<li>Avalia\u00e7\u00e3o do risco.<\/li>\n\n\n\n<li>Regras de classifica\u00e7\u00e3o.<\/li>\n\n\n\n<li>Instru\u00e7\u00f5es de uso e rotulagem para todos os DM.<\/li>\n\n\n\n<li>Valida\u00e7\u00e3o da embalagem (agora mais controlada pelos Organismos Notificados).<\/li>\n\n\n\n<li>Estabilidade.<\/li>\n\n\n\n<li>Carateriza\u00e7\u00e3o do material.<\/li>\n\n\n\n<li>Novos requisitos para a vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o.<\/li>\n\n\n\n<li>Valida\u00e7\u00e3o do transporte.<\/li>\n<\/ul>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-2 kt-pane18552_60d001-6d\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\"><strong>ISO 13485:2016 \u2013 Controlo de qualidade\u00a0<\/strong><\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<p class=\"wp-block-paragraph\"><strong>ISO 13485:2016 \u2013 Controlo de qualidade<\/strong> inclui novos requisitos e uma defini\u00e7\u00e3o dos sistemas de barreira est\u00e9reis que fazem refer\u00eancia \u00e0 ISO 11607. Os novos requisitos para a embalagem incluem a conserva\u00e7\u00e3o dos dispositivo m\u00e9dico atrav\u00e9s da prote\u00e7\u00e3o \u201cdo produto contra altera\u00e7\u00f5es, contamina\u00e7\u00f5es ou danos se exposto \u00e0s condi\u00e7\u00f5es e aos riscos previstos durante o processamento, o armazenamento, a manipula\u00e7\u00e3o e a distribui\u00e7\u00e3o, projetando e construindo embalagens e recipientes de transporte adequados\u201d. Existem tamb\u00e9m requisitos para prevenir a contamina\u00e7\u00e3o de dispositivos est\u00e9reis com part\u00edculas durante a montagem e a embalagem.\u00a0<\/p>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-3 kt-pane18552_3e3b44-6b\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\"><strong>ISO 14971:2007 \u2013 Avalia\u00e7\u00e3o de risco\u00a0<\/strong><\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<p class=\"wp-block-paragraph\"><strong>ISO 14971:2007 \u2013 Avalia\u00e7\u00e3o de risco<\/strong> especifica um processo que visa identificar os perigos associados aos dispositivos m\u00e9dicos, incluindo os dispositivos m\u00e9dicos de diagn\u00f3stico <strong><em>in vitro<\/em><\/strong> (IVD), para estimar e avaliar os riscos, control\u00e1-los e monitorizar a sua efic\u00e1cia. Os requisitos da ISO 14971:2007 s\u00e3o aplic\u00e1veis a todas as fases do ciclo de vida de um dispositivo m\u00e9dico.<\/p>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-4 kt-pane18552_ae4155-87\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\"><strong>ISO 10993-1:2018<\/strong><\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<p class=\"wp-block-paragraph\"><strong>ISO 10993-1:2018<\/strong> \u2013<em> <strong>Biological evaluation of medical devices, Part 1: Evaluation and testing within a risk management process.<\/strong><\/em> <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">O documento especifica:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Os princ\u00edpios gerais que regem a avalia\u00e7\u00e3o biol\u00f3gica dos dispositivos m\u00e9dicos no \u00e2mbito de um processo de gest\u00e3o de risco.<\/li>\n\n\n\n<li>A categoriza\u00e7\u00e3o geral dos dispositivos m\u00e9dicos com base na natureza e dura\u00e7\u00e3o do contacto com o corpo.<\/li>\n\n\n\n<li>A avalia\u00e7\u00e3o dos dados pertinentes existentes de todas as fontes.<\/li>\n\n\n\n<li>A identifica\u00e7\u00e3o das lacunas no conjunto de dados dispon\u00edveis com base numa an\u00e1lise de risco.<\/li>\n\n\n\n<li>A identifica\u00e7\u00e3o de dados adicionais necess\u00e1rios para analisar a seguran\u00e7a biol\u00f3gica do dispositivo m\u00e9dico.<\/li>\n\n\n\n<li>A avalia\u00e7\u00e3o da seguran\u00e7a biol\u00f3gica do dispositivo m\u00e9dico.<\/li>\n<\/ul>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-5 kt-pane18552_fbb32d-7e\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\"><strong>ISO 10993-18:2020\u00a0<\/strong><\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<p class=\"wp-block-paragraph\"><strong>ISO 10993-18:2020<\/strong> \u2013 <em><strong>Biological evaluation of medical devices, Part 18: Chemical characterization of medical device materials within a risk management process.<\/strong>\u00a0<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">O documento especifica uma estrutura para a identifica\u00e7\u00e3o e, se necess\u00e1rio, a quantifica\u00e7\u00e3o dos constituintes de um dispositivo m\u00e9dico, permitindo a identifica\u00e7\u00e3o dos riscos biol\u00f3gicos e a estimativa e controlo dos riscos biol\u00f3gicos dos constituintes do material, utilizando uma abordagem geralmente gradual para a carateriza\u00e7\u00e3o qu\u00edmica.<\/p>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-6 kt-pane18552_fd3c70-b6\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\">\u00a0<strong>ISO 14155:2011 &#8211; Estudos cl\u00ednicos<\/strong>\u00a0<\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<p class=\"wp-block-paragraph\"><strong>ISO 14155:2011<\/strong> \u2013 Os <strong>estudos cl\u00ednicos<\/strong> dizem respeito \u00e0 boa pr\u00e1tica cl\u00ednica para a conce\u00e7\u00e3o, a condu\u00e7\u00e3o, o registo e a notifica\u00e7\u00e3o das investiga\u00e7\u00f5es cl\u00ednicas realizadas em seres humanos para avaliar a seguran\u00e7a ou o desempenho dos dispositivos m\u00e9dicos para fins normativos.<\/p>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-7 kt-pane18552_0ac2c0-dd\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\"><strong>MEDDEV 2.7\/1 &#8211; <strong>Avalia\u00e7\u00f5es cl\u00ednicas<\/strong>\u00a0<\/strong><\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<p class=\"wp-block-paragraph\">As <strong>avalia\u00e7\u00f5es cl\u00ednicas<\/strong> promovem uma abordagem comum \u00e0 avalia\u00e7\u00e3o cl\u00ednica para os dispositivos m\u00e9dicos regulados pelas diretivas 90\/385\/CEE e 93\/42\/CEE. A dura\u00e7\u00e3o e o \u00e2mbito das avalia\u00e7\u00f5es cl\u00ednicas devem ser flex\u00edveis e adequados \u00e0 natureza, \u00e0 finalidade de uso e aos riscos do dispositivo em quest\u00e3o.<\/p>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-8 kt-pane18552_36b216-92\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\"><strong>EMA GUIDELINE DDCs (2019)<\/strong><\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<p class=\"wp-block-paragraph\">O dossi\u00ea do produto medicinal deve incluir uma avalia\u00e7\u00e3o completa do impacto do dispositivo no perfil do produto alvo de qualidade (QTTP), nos atributos cr\u00edticos de qualidade (CQA) e na estrat\u00e9gia global de controlo do produto medicinal.<\/p>\n<\/div><\/div><\/div>\n\n\n\n<div class=\"wp-block-kadence-pane kt-accordion-pane kt-accordion-pane-9 kt-pane18552_ec79bd-c4\"><div class=\"kt-accordion-header-wrap\"><button class=\"kt-blocks-accordion-header kt-acccordion-button-label-show\" type=\"button\"><span class=\"kt-blocks-accordion-title-wrap\"><span class=\"kt-blocks-accordion-title\"><strong>ISO espec\u00edficas\u00a0<\/strong><\/span><\/span><span class=\"kt-blocks-accordion-icon-trigger\"><\/span><\/button><\/div><div class=\"kt-accordion-panel kt-accordion-panel-hidden\"><div class=\"kt-accordion-panel-inner\">\n<p class=\"wp-block-paragraph\"><strong>ISO espec\u00edficas<\/strong>, dependendo da natureza do dispositivo.<\/p>\n<\/div><\/div><\/div>\n<\/div><\/div><\/div>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Solu\u00e7\u00f5es inovadoras para o setor da sa\u00fade O Regulamento 745\/2017 define como Dispositivo M\u00e9dico qualquer instrumento, aparelho, equipamento, software, implante, reagente, material ou outro artigo, destinado pelo fabricante a ser empregue em seres humanos, sozinho ou em combina\u00e7\u00e3o, para uma ou mais finalidades m\u00e9dicas espec\u00edficas. O Regulamento (UE) 2017\/745 O Regulamento aplica-se desde 26 de&#8230;<\/p>\n","protected":false},"author":16,"featured_media":19790,"parent":18535,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"service-page-pharma-blue.php","meta":{"_acf_changed":false,"_kad_blocks_custom_css":"","_kad_blocks_head_custom_js":"","_kad_blocks_body_custom_js":"","_kad_blocks_footer_custom_js":"","_kad_post_transparent":"","_kad_post_title":"","_kad_post_layout":"","_kad_post_sidebar_id":"","_kad_post_content_style":"","_kad_post_vertical_padding":"","_kad_post_feature":"","_kad_post_feature_position":"","_kad_post_header":false,"_kad_post_footer":false,"_kad_post_classname":"","footnotes":""},"folder":[1758],"class_list":["post-18552","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"taxonomy_info":[],"featured_image_src_large":["https:\/\/www.merieuxnutrisciences.com\/wp-content\/uploads\/2022\/05\/medical-devices.png",1024,299,false],"author_info":{"display_name":"Rui Nogueira","author_link":"https:\/\/www.merieuxnutrisciences.com\/pt\/author\/rui\/"},"comment_info":0,"_links":{"self":[{"href":"https:\/\/www.merieuxnutrisciences.com\/pt\/wp-json\/wp\/v2\/pages\/18552","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.merieuxnutrisciences.com\/pt\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.merieuxnutrisciences.com\/pt\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/pt\/wp-json\/wp\/v2\/users\/16"}],"replies":[{"embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/pt\/wp-json\/wp\/v2\/comments?post=18552"}],"version-history":[{"count":10,"href":"https:\/\/www.merieuxnutrisciences.com\/pt\/wp-json\/wp\/v2\/pages\/18552\/revisions"}],"predecessor-version":[{"id":225810,"href":"https:\/\/www.merieuxnutrisciences.com\/pt\/wp-json\/wp\/v2\/pages\/18552\/revisions\/225810"}],"up":[{"embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/pt\/wp-json\/wp\/v2\/pages\/18535"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/pt\/wp-json\/wp\/v2\/media\/19790"}],"wp:attachment":[{"href":"https:\/\/www.merieuxnutrisciences.com\/pt\/wp-json\/wp\/v2\/media?parent=18552"}],"wp:term":[{"taxonomy":"folder","embeddable":true,"href":"https:\/\/www.merieuxnutrisciences.com\/pt\/wp-json\/wp\/v2\/folder?post=18552"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}