{"id":664,"date":"2022-08-10T15:05:43","date_gmt":"2022-08-10T13:05:43","guid":{"rendered":"https:\/\/www.biotopmedical.nl\/technical-documentation\/in-vitro-diagnostic-devices-regulations\/"},"modified":"2023-06-15T11:57:06","modified_gmt":"2023-06-15T09:57:06","slug":"wetgeving-medische-hulpmiddelen-voor-in-vitrodiagnostiek","status":"publish","type":"page","link":"https:\/\/www.biotopmedical.nl\/nl\/technische-documentatie\/wetgeving-medische-hulpmiddelen-voor-in-vitrodiagnostiek\/","title":{"rendered":"Wetgeving medische hulpmiddelen voor in-vitrodiagnostiek"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row full_width=&#8221;stretch_row&#8221; equal_height=&#8221;yes&#8221; css=&#8221;.vc_custom_1662038703013{padding-top: 0px !important;padding-bottom: 0px !important;}&#8221; el_class=&#8221;sidebar-row&#8221;][vc_column width=&#8221;1\/4&#8243; col_color=&#8221;bg_lightpurple&#8221; el_class=&#8221;left-sidebar&#8221;]\r\n        <div class=\"sd-block-menu  marginbottom-40px\r\n        \">\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h3 class=\"sd-block-title-htag  marginbottom-0px align-left color-black\r\n            \">Technical Documentation File<\/h3>\r\n        <\/div><ul><li class=\"menu-item\">\r\n                    <a href=\"https:\/\/www.biotopmedical.nl\/technical-documentation\/medical-device-risk-management\/\">Medical device risk management<span class=\"expand\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/span><\/a><\/li><li class=\"menu-item\">\r\n                    <a href=\"https:\/\/www.biotopmedical.nl\/technical-documentation\/clinical-evaluation-mdr\/\">Clinical Evaluation &#038; MDR<span class=\"expand\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/span><\/a><\/li><li class=\"menu-item\">\r\n                    <a href=\"https:\/\/www.biotopmedical.nl\/technical-documentation\/systematic-literature-searches\/\">Systematic Literature Searches<span class=\"expand\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/span><\/a><\/li><li class=\"menu-item\">\r\n                    <a href=\"https:\/\/www.biotopmedical.nl\/technical-documentation\/biological-safety-assessment\/\">Biological Evaluation<span class=\"expand\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/span><\/a><\/li><li class=\"menu-item\">\r\n                    <a href=\"https:\/\/www.biotopmedical.nl\/technical-documentation\/other\/\">Other<span class=\"expand\"><svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewBox=\"0 0 256 512\"><path fill=\"currentColor\" d=\"M64 448c-8.188 0-16.38-3.125-22.62-9.375c-12.5-12.5-12.5-32.75 0-45.25L178.8 256L41.38 118.6c-12.5-12.5-12.5-32.75 0-45.25s32.75-12.5 45.25 0l160 160c12.5 12.5 12.5 32.75 0 45.25l-160 160C80.38 444.9 72.19 448 64 448z\"\/><\/svg><\/span><\/a><\/li><\/ul>\r\n        <\/div>\r\n        <div class=\"sd-block-image  align-center marginbottom-40px snake-icon\r\n        \"><img decoding=\"async\" title=\"\" alt=\"\" src=\"https:\/\/www.biotopmedical.nl\/wp-content\/uploads\/2022\/08\/snake-icon-v2-1.svg\" width=\"600\" height=\"500\">\r\n        <\/div>[vc_row_inner][vc_column_inner col_color=&#8221;bg_white&#8221;]\r\n        <div class=\"sd-block-text  marginbottom-0px color-black\r\n        \">\r\n            <p>Voor rechtstreeks contact belt u<br \/>\n<a href=\"tel:+31715280112\">+31 (0)71 528 01 12<\/a><strong><br \/>\n<\/strong><\/p>\n\r\n        <\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=&#8221;1\/12&#8243;][\/vc_column][vc_column css_animation=&#8221;fadeInUp&#8221; width=&#8221;2\/3&#8243; el_class=&#8221;right-sidebar&#8221;]\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h2 class=\"sd-block-title-htag  marginbottom-20px align-left color-purple bg bg-lightpurple font-middle\r\n            \">Technische documentatie<\/h2>\r\n        <\/div>\r\n        <div class=\"sd-block-title  align-left\">\r\n            <h1 class=\"sd-block-title-htag  marginbottom-20px align-left color-white bg bg-purple font-middle\r\n            \">Wetgeving medische hulpmiddelen voor in-vitrodiagnostiek (IVDR)<\/h1>\r\n        <\/div>[vc_row_inner content_placement=&#8221;middle&#8221;][vc_column_inner width=&#8221;2\/3&#8243;]\r\n        <div class=\"sd-block-text  marginbottom-20px\r\n        \">\r\n            <p>De Europese wetgeving betreffende medische hulpmiddelen voor in-vitrodiagnostiek, Verordening EU 2017\/746 &#8216;IVDR&#8217;, is in mei 2017 in werking getreden. Deze wetgeving heeft richtlijn 98\/79\/EG &#8216;IVDD&#8217; ingetrokken met een overgangsperiode van vijf jaar om naleving te bereiken en is van kracht sinds mei 2022. Volledige naleving van de regelgeving is verplicht voor fabrikanten die hun producten op de Europese markt willen brengen.<\/p>\n\r\n        <\/div>[\/vc_column_inner][vc_column_inner width=&#8221;1\/3&#8243;]\r\n        <div class=\"sd-block-image  align-center marginbottom-40px\r\n        \"><img decoding=\"async\" title=\"\" alt=\"\" src=\"https:\/\/www.biotopmedical.nl\/wp-content\/uploads\/2022\/11\/ivdr_regulations.jpg\" width=\"600\" height=\"500\">\r\n        <\/div>[\/vc_column_inner][\/vc_row_inner]\r\n        <div class=\"sd-block-text  marginbottom-20px\r\n        \">\r\n            <p>Fabrikanten zijn verplicht om \u200b\u200btechnische documentatie op te stellen die bestaat uit zeer gedetailleerde productinformatie. Deze documentatie moet worden opgesteld in overeenstemming met de regelgeving, normen die van toepassing zijn en andere relevante begeleidingsdocumenten. Bovendien moet deze documentatie regelmatig worden onderhouden en bijgewerkt.<\/p>\n\r\n        <\/div>\r\n        <div class=\"sd-block-text  marginbottom-20px\r\n        \">\r\n            <p>Vanwege de complexiteit van de taak en de grote hoeveelheid documenten die moet worden voorbereid, kan het samenstellen van de technische documentatie overweldigend zijn. BioTop Medical kan deze verantwoordelijkheid van u overnemen.<\/p>\n\r\n        <\/div>\r\n        <div class=\"sd-block-button  marginbottom-40px style-solid color-purple\">\r\n            <a href=\"https:\/\/www.biotopmedical.nl\/nl\/neem-contact-met-ons-op\/\" title=\"Neem contact op\">Neem contact op<\/a>\r\n        <\/div>[\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row full_width=&#8221;stretch_row&#8221; equal_height=&#8221;yes&#8221; css=&#8221;.vc_custom_1662038703013{padding-top: 0px !important;padding-bottom: 0px !important;}&#8221; el_class=&#8221;sidebar-row&#8221;][vc_column width=&#8221;1\/4&#8243; col_color=&#8221;bg_lightpurple&#8221; el_class=&#8221;left-sidebar&#8221;][vc_row_inner][vc_column_inner col_color=&#8221;bg_white&#8221;][\/vc_column_inner][\/vc_row_inner][\/vc_column][vc_column width=&#8221;1\/12&#8243;][\/vc_column][vc_column css_animation=&#8221;fadeInUp&#8221; width=&#8221;2\/3&#8243; el_class=&#8221;right-sidebar&#8221;][vc_row_inner content_placement=&#8221;middle&#8221;][vc_column_inner width=&#8221;2\/3&#8243;][\/vc_column_inner][vc_column_inner width=&#8221;1\/3&#8243;][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":663,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-664","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Wetgeving medische hulpmiddelen voor in-vitrodiagnostiek | BioTop Medical<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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