{"id":859,"date":"2024-03-25T15:43:39","date_gmt":"2024-03-25T15:43:39","guid":{"rendered":"https:\/\/www.varodem.com\/?page_id=859"},"modified":"2025-04-05T14:00:58","modified_gmt":"2025-04-05T12:00:58","slug":"mdr","status":"publish","type":"page","link":"https:\/\/www.varodem.com\/nl\/mdr\/","title":{"rendered":"MDR"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"859\" class=\"elementor elementor-859\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-05d8ebb elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"05d8ebb\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-de8c6e0\" data-id=\"de8c6e0\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-da8a92f elementor-widget elementor-widget-text-editor\" data-id=\"da8a92f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Er zijn nieuwe regels voor medische hulpmiddelen (MDR). Het doel van deze nieuwe regels is de <strong>pati\u00ebntveiligheid<\/strong> in de Europese Unie te vergroten en ervoor te zorgen dat innovatieve medische hulpmiddelen beschikbaar blijven voor de pati\u00ebnt. Dit brengt grote veranderingen met zich mee.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-fd05459 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"fd05459\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-707db26\" data-id=\"707db26\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-74b6fa2 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"74b6fa2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-3a30776 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"3a30776\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-17a712c\" data-id=\"17a712c\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-02839b6 elementor-widget elementor-widget-heading\" data-id=\"02839b6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Waarom?<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0d83b6e elementor-widget elementor-widget-text-editor\" data-id=\"0d83b6e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Om de pati\u00ebntveiligheid te kunnen garanderen zijn er nieuwe, strengere, Europese regels om de veiligheid van medische hulpmiddelen te verbeteren. Deze regels gelden uiteraard ook in Nederland. De eisen aan medische hulpmiddelen om in aanmerking te komen voor markttoelating in de Europese Unie zijn strikter geworden.\u00a0Dat geldt ook voor de eisen die gesteld zijn aan instanties die verantwoordelijk zijn voor de markttoelating van hulpmiddelen (Notified Bodies) en aan fabrikanten, importeurs en distributeurs.<\/p><p>Er komen strengere regels voor het op de markt brengen van hulpmiddelen\u00a0 op producten die al op de markt zijn gebracht. Pleisters, kunstheupen en pacemakers, maar ook laboratorium- en zwangerschapstesten: allen behoren ze tot de medische hulpmiddelen en in-vitro diagnostica. Medische hulpmiddelen leveren een belangrijke bijdrage aan de kwaliteit van leven en de gezondheid van pati\u00ebnten. De nieuwe regelgeving schept daarom belangrijke voorwaarden voor een goedwerkende interne markt voor de 25.000 fabrikanten van medische hulpmiddelen in de Europese Unie.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-3f5df06 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"3f5df06\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ab8d2f0\" data-id=\"ab8d2f0\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3e07737 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"3e07737\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-78267db elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"78267db\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-eee7fdc\" data-id=\"eee7fdc\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-ed3b01f elementor-widget elementor-widget-heading\" data-id=\"ed3b01f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Wanneer?<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-95a3768 elementor-widget elementor-widget-text-editor\" data-id=\"95a3768\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Per <strong>26 mei 2021<\/strong> zal de Europese wet- en regelgeving, beter bekend als de Medical Device Directory (MDR) in werking treden. Hiermee komt de nu geldende MDD te vervallen. Deze nieuwe MDR geldt voor alle medische hulpmiddelen die binnen de Europese gemeenschap gemaakt, verhandelt en\/of verwerkt worden. Van scalpel, injectienaalden tot pacemakers, van contact lenzen tot prothese, voor al deze hulpmiddelen geldt dezelfde Europese wetgeving. De introductie van de MDR was oorspronkelijk gepland op 26 mei 2020 maar is, als gevolg van de wereldwijde Covid-19 pandemie uitgesteld tot mei 2021.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-6e8390d elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"6e8390d\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5ee5c50\" data-id=\"5ee5c50\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-bc70196 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"bc70196\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-450a24b elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"450a24b\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-8ce2f39\" data-id=\"8ce2f39\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-10c8fab elementor-widget elementor-widget-heading\" data-id=\"10c8fab\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Wat?<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e3f55c4 elementor-widget elementor-widget-text-editor\" data-id=\"e3f55c4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>De nieuwe wetgeving stelt strengere eisen aan de markttoelating van medische hulpmiddelen en wijst duidelijke verantwoordelijkheden aan voor alle economische deelnemers.\u00a0In de MDR zijn duidelijke regels opgenomen voor de fabrikanten om de kwaliteit, prestatie en veiligheid van hulpmiddelen te\u00a0bewaken na de markttoelating. Uitgangspunt is dat de fabrikant verantwoordelijk blijft voor de kwaliteit van zijn hulpmiddelen gedurende de gehele levenscyclus van het product. Gebreken met hulpmiddelen worden vaak pas na verloop van tijd duidelijk. Door de nieuwe regels kan bij incidenten sneller worden ingegrepen.<\/p><p>Ook kan de informatie over de prestaties van het product worden gebruikt voor productverbeteringen.\u00a0Fabrikanten, gemachtigden en andere marktpartijen krijgen ook andere duidelijke verantwoordelijkheden.\u00a0Tot slot komt er met de nieuwe regels meer duidelijkheid over wie aansprakelijk is als een hulpmiddel gebreken vertoont.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-3f802c1 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"3f802c1\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-bc9c9c8\" data-id=\"bc9c9c8\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-bd26874 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"bd26874\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-ca2f006 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"ca2f006\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-851a3e0\" data-id=\"851a3e0\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4eea086 elementor-widget elementor-widget-heading\" data-id=\"4eea086\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Wie?<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5ec66fb elementor-widget elementor-widget-text-editor\" data-id=\"5ec66fb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Voor het eerst heeft de MDR ook de distributeur als marktdeelnemer aangemerkt en verplichtingen opgelegd aan zijn rol. Deze zijn duidelijk omschreven in artikel 14 van de MDR \u201cVerplichtingen van de distributeur\u201d en kunnen worden onderverdeeld in zorgvuldigheidsplicht, controleplicht en informatieplicht.\u00a0<strong>Onze tip:\u00a0Ken de regelgeving in uw eigen branche. <\/strong>Binnen de constellatie van wet- en regelgeving van de MDR vervult Varodem de rol van <strong>fabrikant<\/strong>.\u00a0Bent u leverancier van een van de hieronder genoemde medische hulpmiddelen, dan vervult u de rol van <strong>distributeur<\/strong>.<\/p><p>Varodem is een fabrikant van medische hulpmiddelen. Al\u00a0onze producten zijn medische hulpmiddelen van risicoklasse <strong>I<\/strong>en behoren dus tot de <strong>laagste risicoklasse<\/strong>\u00a0volgens de MDR.\u00a0Als fabrikant van medische hulpmiddelen met een laag risico mogen wij zelf bepalen of de hulpmiddelen in overeenstemming zijn met de toepasselijke eisen van de verordening en de conformiteitsverklaring afgeven volgens bijlage VIII van de EU-verordening 2017\/745 betreffende medische hulpmiddelen.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-d94f401 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"d94f401\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-21149dd\" data-id=\"21149dd\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-0756d41 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"0756d41\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-6987e85 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"6987e85\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-649d80b\" data-id=\"649d80b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-0f87540 elementor-widget elementor-widget-heading\" data-id=\"0f87540\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Samenspel<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-645e7e1 elementor-widget elementor-widget-text-editor\" data-id=\"645e7e1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>In het samenspel tussen fabrikant en distributeur is een duidelijke set aan regels en verantwoordelijkheden opgenomen die elk de ruimte geeft een eigen rol te vervullen. Zo moet de distributeur, wanneer hij\/zij een product op de markt brengt, de nodige zorgvuldigheid betrachten in verband met de toepasselijke voorschriften van de MDR. Dit betekent dat in het kader van de bedrijfsactiviteiten rekening moet worden gehouden met de nieuwe eisen die voortvloeien uit de MDR, zoals de hieronder beschreven controle- en informatieplichten.\u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-6d71f3c elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"6d71f3c\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-502d933\" data-id=\"502d933\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-fcf4923 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"fcf4923\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-1dc3949 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"1dc3949\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-7e67f0b\" data-id=\"7e67f0b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-a939a40 elementor-widget elementor-widget-heading\" data-id=\"a939a40\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Wat doet Varodem?<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2d5856b elementor-widget elementor-widget-text-editor\" data-id=\"2d5856b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>CE-certificering<\/strong><br \/>Onze medische compressiehulpmiddelen zijn voorzien van een CE-certificering. Dit staat duidelijk aangegeven op onze productlabels en verpakkingsetiketten.<\/p><p><strong>EU-conformiteitsverklaring<\/strong><br \/>Varodem heeft de benodigde EU-conformiteitsverklaring (Declaration of Conformity) geregistreerd bij het Centrum voor Certificering. Dit is een noodzakelijke eis voor opname van onze producten op de <a href=\"http:\/\/www.lijstvanbernink.nl\/\" target=\"_blank\" rel=\"noopener\">Lijst van Bernink<\/a>, het kwaliteitsregister van de SEMH.<\/p><p><a href=\"https:\/\/media-service.juzo.de\/exports\/Varodem\/326943.pdf\" target=\"_blank\" rel=\"noopener\">Declaration of Conformity &#8211; Duits \/ Engels<\/a><br \/><a href=\"https:\/\/media-service.juzo.de\/exports\/Varodem\/326945.pdf\" target=\"_blank\" rel=\"noopener\">Declaration of Conformity &#8211; Nederlands \/ Engels<\/a><br \/><a href=\"https:\/\/media-service.juzo.de\/exports\/Varodem\/326944.pdf\" target=\"_blank\" rel=\"noopener\">Declaration of Conformity &#8211; Frans \/ Engels<\/a><br \/><a href=\"https:\/\/media-service.juzo.de\/exports\/Varodem\/354729.pdf\" target=\"_blank\" rel=\"noopener\">Declaration of Conformity &#8211; Duits \/ Engels<\/a> (VaroLiner)<br \/><a href=\"https:\/\/media-service.juzo.de\/exports\/Varodem\/354730.pdf\" target=\"_blank\" rel=\"noopener\">Declaration of Conformity &#8211; Nederlands \/ Engels<\/a> (VaroLiner)<br \/><a href=\"https:\/\/media-service.juzo.de\/exports\/Varodem\/334641.pdf\" target=\"_blank\" rel=\"noopener\">Declaration of Conformity &#8211; Frans \/ Engels<\/a> (VaroLiner)<\/p><p><strong>Etikettering en productinformatie<br \/><\/strong>Al onze productlabels en verpakkingsetiketten zijn voorzien van de juiste informatie (MDR conform) Zo treft u ook de verplichte UDI code aan (op de verpakkingsetiketten).<\/p><p><strong>RAL certificering<\/strong><br \/>Alle therapeutische elastische kousen van Varodem zijn RAL gecertificeerd. Hiertoe is Varodem lid van de <a href=\"https:\/\/www.gzg-kompressionsstruempfe.de\/\" target=\"_blank\" rel=\"noopener\">G\u00fctenzeichengemeinschaft Medizinische Kompressionsstr\u00fcmpfe<\/a>. Deze tests zijn uitgevoerd bij het Duitse testinstituut <a href=\"https:\/\/www.hohenstein.com\/en\/\" target=\"_blank\" rel=\"noopener\">Hohenstein<\/a>.<\/p><p><strong>Productinformatie<br \/><\/strong>Productinformatie waaronder gebruikstoepassingen, medische indicatie, de houdbaarheid, de opslagcondities en onderhoudsinformatie treft u aan in de gebruiksaanwijzing die u bij elk compressiehulpmiddel aantreft.<\/p><p><strong>Archief<br \/><\/strong>Zoals de wet- en regelgeving aangeeft, dienen ook van de Varodem producten die niet meer verkrijgbaar zijn, beschikbaar te blijven. Hier treft u deze bestanden aan:<a href=\"https:\/\/media-service.juzo.de\/exports\/Varodem\/326942.pdf\" target=\"_blank\" rel=\"noopener\"> Progress 1 XT<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-25edd53 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"25edd53\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-97719a7\" data-id=\"97719a7\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-393eb1f elementor-widget elementor-widget-spacer\" data-id=\"393eb1f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Er zijn nieuwe regels voor medische hulpmiddelen (MDR). Het doel van deze nieuwe regels is de pati\u00ebntveiligheid in de Europese&hellip;<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-859","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.8 (Yoast SEO v26.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>MDR - Varodem<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.varodem.com\/nl\/mdr\/\" \/>\n<meta property=\"og:locale\" content=\"nl_NL\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MDR\" \/>\n<meta property=\"og:description\" content=\"Er zijn nieuwe regels voor medische hulpmiddelen (MDR). Het doel van deze nieuwe regels is de pati\u00ebntveiligheid in de Europese&hellip;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.varodem.com\/nl\/mdr\/\" \/>\n<meta property=\"og:site_name\" content=\"Varodem\" \/>\n<meta property=\"article:modified_time\" content=\"2025-04-05T12:00:58+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Geschatte leestijd\" \/>\n\t<meta name=\"twitter:data1\" content=\"5 minuten\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.varodem.com\/nl\/mdr\/\",\"url\":\"https:\/\/www.varodem.com\/nl\/mdr\/\",\"name\":\"MDR - Varodem\",\"isPartOf\":{\"@id\":\"https:\/\/www.varodem.com\/nl\/#website\"},\"datePublished\":\"2024-03-25T15:43:39+00:00\",\"dateModified\":\"2025-04-05T12:00:58+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/www.varodem.com\/nl\/mdr\/#breadcrumb\"},\"inLanguage\":\"nl-NL\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.varodem.com\/nl\/mdr\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.varodem.com\/nl\/mdr\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.varodem.com\/nl\/home\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"MDR\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.varodem.com\/nl\/#website\",\"url\":\"https:\/\/www.varodem.com\/nl\/\",\"name\":\"Varodem\",\"description\":\"All about people!\",\"publisher\":{\"@id\":\"https:\/\/www.varodem.com\/nl\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.varodem.com\/nl\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"nl-NL\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.varodem.com\/nl\/#organization\",\"name\":\"Varodem\",\"url\":\"https:\/\/www.varodem.com\/nl\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"nl-NL\",\"@id\":\"https:\/\/www.varodem.com\/nl\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.varodem.com\/wp-content\/uploads\/2024\/01\/logo.svg\",\"contentUrl\":\"https:\/\/www.varodem.com\/wp-content\/uploads\/2024\/01\/logo.svg\",\"caption\":\"Varodem\"},\"image\":{\"@id\":\"https:\/\/www.varodem.com\/nl\/#\/schema\/logo\/image\/\"}}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"MDR - Varodem","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.varodem.com\/nl\/mdr\/","og_locale":"nl_NL","og_type":"article","og_title":"MDR","og_description":"Er zijn nieuwe regels voor medische hulpmiddelen (MDR). 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