{"id":3216,"date":"2026-04-08T07:53:50","date_gmt":"2026-04-08T07:53:50","guid":{"rendered":"https:\/\/serviceshop.aedlab.nl\/?post_type=veelgestelde-vraag&#038;p=3216"},"modified":"2026-04-08T07:53:52","modified_gmt":"2026-04-08T07:53:52","slug":"9-belangrijke-veranderingen-door-de-mdr","status":"publish","type":"veelgestelde-vraag","link":"https:\/\/serviceshop.aedlab.nl\/fr\/veelgestelde-vraag\/9-belangrijke-veranderingen-door-de-mdr\/","title":{"rendered":"9 belangrijke veranderingen door de MDR"},"content":{"rendered":"<p><strong>1. Groter toepassingsbereik: <\/strong>meer medische hulpmiddelen vallen onder de nieuwe wetgeving.<\/p>\n\n\n\n<p><strong>2. Klinisch bewijs en documentatie:<\/strong> voor medische hulpmiddelen van klasse III, zoals automatische externe defibrillatoren (AED&#8217;s), gelden strengere eisen.<\/p>\n\n\n\n<p><strong>3. Systematische klinische beoordeling:<\/strong> fabrikanten van medische hulpmiddelen van klasse IIa en IIb moeten hun klinische gegevens evalueren en aantonen dat hun hulpmiddel veilig en effectief is.<\/p>\n\n\n\n<p><strong>4. Documentatie:<\/strong> striktere en duidelijkere eisen.<\/p>\n\n\n\n<p><strong>5. Traceerbaarheid:<\/strong> hulpmiddelen zijn beter traceerbaar via unieke identificatiecodes (UDI&#8217;s).<\/p>\n\n\n\n<p><strong>6. Toezicht door aangemelde instanties:<\/strong> de regels voor toezicht tijdens en na certificering zijn aangescherpt om risico&#8217;s van onveilige hulpmiddelen te verminderen. Er wordt meer en vaker getoetst.<\/p>\n\n\n\n<p><strong>7. Verantwoordelijke voor regelgeving (PRRC):<\/strong> elke fabrikant en gemachtigde moet een verantwoordelijke aanstellen die toeziet op naleving van de regelgeving.<\/p>\n\n\n\n<p><strong>8. Hernieuwde goedkeuring verplicht: <\/strong>voor alle hulpmiddelen moet opnieuw goedkeuring worden aangevraagd om ze onder de MDR in de handel te brengen.<\/p>\n\n\n\n<p><strong>9. Doorgeven van meldingen:<\/strong> ketendeelnemers moeten meldingen over leveringsonderbrekingen die zij van een Europese fabrikant ontvangen, doorgeven aan hun afnemers.<\/p>","protected":false},"featured_media":0,"template":"","meta":{"_acf_changed":false,"_breakdance_hide_in_design_set":false,"_breakdance_tags":""},"faq-categorie":[34],"class_list":["post-3216","veelgestelde-vraag","type-veelgestelde-vraag","status-publish","hentry","faq-categorie-mdr"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>9 belangrijke veranderingen door de MDR - AED-partner<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"9 belangrijke veranderingen door de MDR - AED-partner\" \/>\n<meta property=\"og:description\" content=\"1. Groter toepassingsbereik: meer medische hulpmiddelen vallen onder de nieuwe wetgeving. 2. Klinisch bewijs en documentatie: voor medische hulpmiddelen van klasse III, zoals automatische externe defibrillatoren (AED&#8217;s), gelden strengere eisen. 3. 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