{"id":3219,"date":"2026-04-08T08:31:35","date_gmt":"2026-04-08T08:31:35","guid":{"rendered":"https:\/\/serviceshop.aedlab.nl\/?post_type=kennis&#038;p=3219"},"modified":"2026-04-15T14:16:16","modified_gmt":"2026-04-15T14:16:16","slug":"medical-device-regulation","status":"publish","type":"kennis","link":"https:\/\/serviceshop.aedlab.nl\/fr\/kennis\/medical-device-regulation\/","title":{"rendered":"R\u00e8glementation des dispositifs m\u00e9dicaux"},"content":{"rendered":"<section class=\"bde-section-3219-100 bde-section\">\n  \n  \n\t\n\n\n\n<div class=\"section-container\"><div class=\"bde-icon-list-3219-101 bde-icon-list\">\n<ul>\n  \n              \n    <li>\n                      \n            \n            \n\n    \n    \n    \n    \n    \n    <a class=\"breakdance-link bde-icon-list__item-wrapper\" href=\"https:\/\/serviceshop.aedlab.nl\/fr\/kennis-en-nieuws\/\" target=\"_self\" data-type=\"url\"  >\n\n      \n      <span class='bde-icon-list__icon'>\n        <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 512 512\"><!--! Font Awesome Pro 7.0.1 by @fontawesome - https:\/\/fontawesome.com License - https:\/\/fontawesome.com\/license (Commercial License) Copyright 2025 Fonticons, Inc. --><path fill=\"currentColor\" d=\"M4.7 244.7c-6.2 6.2-6.2 16.4 0 22.6l176 176c6.2 6.2 16.4 6.2 22.6 0s6.2-16.4 0-22.6L54.6 272 496 272c8.8 0 16-7.2 16-16s-7.2-16-16-16L54.6 240 203.3 91.3c6.2-6.2 6.2-16.4 0-22.6s-16.4-6.2-22.6 0l-176 176z\"\/><\/svg>\n      <\/span>\n      <span class='bde-icon-list__text' >\n      Consulter toutes les connaissances et actualit\u00e9s\n      <\/span>\n                  <\/a>\n\n      \n    <\/li>\n\n  <\/ul>\n\n<\/div><\/div>\n<\/section><section class=\"bde-section-3219-102 bde-section\">\n  \n  \n\t\n\n\n\n<div class=\"section-container\"><div class=\"bde-columns-3219-103 bde-columns\"><div class=\"bde-column-3219-104 bde-column\">\n  \n  \n\t\n\n\n\n<div class=\"bde-div-3219-105 bde-div\">\n  \n  \n\t\n\n\n\n<h1 class=\"bde-heading-3219-106 bde-heading\">\nR\u00e8glementation des dispositifs m\u00e9dicaux\n<\/h1><img decoding=\"async\" class=\"bde-image2-3219-107 bde-image2\" src=\"https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/MDR-AED-Partner.jpg\" loading=\"lazy\" srcset=\"https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/MDR-AED-Partner.jpg 1600w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/MDR-AED-Partner-300x209.jpg 300w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/MDR-AED-Partner-1024x712.jpg 1024w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/MDR-AED-Partner-768x534.jpg 768w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/MDR-AED-Partner-1536x1068.jpg 1536w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/MDR-AED-Partner-18x12.jpg 18w\" sizes=\"(max-width: 1600px) 100vw, 1600px\"><div class=\"bde-rich-text-3219-111 bde-rich-text breakdance-rich-text-styles\">\n<p><span style=\"font-weight: 400;\">De Medical Device Regulation (MDR) is een Europese wet voor medische hulpmiddelen. Deze wet zorgt dat medische hulpmiddelen die op de Europese markt worden aangeboden, veilig zijn voor pati\u00ebnten. De Nederlandse naam van deze wet is de <\/span><i><span style=\"font-weight: 400;\">Verordening Medische Hulpmiddelen<\/span><\/i><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Heb je een vraag of een bepaalde AED aan de MDR voldoet? Onze medewerkers kennen alle toestellen goed en geven je gratis advies. Je kunt hiervoor contact opnemen met onze <a href=\"https:\/\/serviceshop.aedlab.nl\/fr\/service-a-la-clientele\/\">Service \u00e0 la client\u00e8le<\/a>.<\/span><\/p>\n<\/div><div class=\"bde-post-loop-3219-124 bde-post-loop\"><div class=\"bde-loop bde-loop-grid ee-posts ee-posts-grid\">    <article class=\"bde-loop-item ee-post\">\n        <div class=\"bde-frequently-asked-questions-2803-101-3225-2803-1 bde-frequently-asked-questions bde-frequently-asked-questions-2803-101\">\n      <div class=\"bde-faq__item\">\n      <h3 class=\"bde-faq__title-tag\">\n       <button id=\"bde-faq-101-button-1\" aria-expanded=\"false\" aria-controls=\"bde-faq-101-1\" class=\"bde-faq__question js-faq-item\">\n          <span class=\"bde-faq__title\">Quand AED-Partner exp\u00e9diera-t-il ma commande ?<\/span>\n                           <div aria-hidden=\"true\" class=\"bde-faq__icon bde-faq__icon--inactive\">\n                                <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 384 512\"><!--! Font Awesome Pro 7.0.1 by @fontawesome - https:\/\/fontawesome.com License - https:\/\/fontawesome.com\/license (Commercial License) Copyright 2025 Fonticons, Inc. --><path fill=\"currentColor\" d=\"M180.7 363.3c6.2 6.2 16.4 6.2 22.6 0l160-160c6.2-6.2 6.2-16.4 0-22.6s-16.4-6.2-22.6 0L192 329.4 43.3 180.7c-6.2-6.2-16.4-6.2-22.6 0s-6.2 16.4 0 22.6l160 160z\"\/><\/svg>\n                            <\/div>\n         \t  <div aria-hidden=\"true\" class=\"bde-faq__icon bde-faq__icon--active\">\n                                <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 384 512\"><!--! Font Awesome Pro 7.0.1 by @fontawesome - https:\/\/fontawesome.com License - https:\/\/fontawesome.com\/license (Commercial License) Copyright 2025 Fonticons, Inc. --><path fill=\"currentColor\" d=\"M180.7 148.7c6.2-6.2 16.4-6.2 22.6 0l160 160c6.2 6.2 6.2 16.4 0 22.6s-16.4 6.2-22.6 0L192 182.6 43.3 331.3c-6.2 6.2-16.4 6.2-22.6 0s-6.2-16.4 0-22.6l160-160z\"\/><\/svg>\n                            <\/div>\n                  <\/button>\n      <\/h3>\n      <div role=\"region\" aria-labelledby=\"bde-faq-101-button-1\" id=\"bde-faq-101-1\" class=\"bde-faq__answer\">\n        <div class=\"bde-faq__answer-content\">\n            <div class=\"breakdance-rich-text-styles\">\n<p>Les commandes pass\u00e9es les jours ouvrables avant 16h00 sont exp\u00e9di\u00e9es le jour m\u00eame. AED-Partner s'efforce de livrer tous les produits de la boutique en ligne en stock. Si un produit n'est pas en stock, nous vous contacterons dans un d\u00e9lai d'un jour ouvrable.<\/p>\n<\/div>\n\n                    <\/div>\n      <\/div>\n    <\/div>\n  \n<\/div>    <\/article>\n    <article class=\"bde-loop-item ee-post\">\n        <div class=\"bde-frequently-asked-questions-2803-101-3221-2803-1 bde-frequently-asked-questions bde-frequently-asked-questions-2803-101\">\n      <div class=\"bde-faq__item\">\n      <h3 class=\"bde-faq__title-tag\">\n       <button id=\"bde-faq-101-button-1\" aria-expanded=\"false\" aria-controls=\"bde-faq-101-1\" class=\"bde-faq__question js-faq-item\">\n          <span class=\"bde-faq__title\">Comment puis-je retournerner un produit ?<\/span>\n                           <div aria-hidden=\"true\" class=\"bde-faq__icon bde-faq__icon--inactive\">\n                                <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 384 512\"><!--! Font Awesome Pro 7.0.1 by @fontawesome - https:\/\/fontawesome.com License - https:\/\/fontawesome.com\/license (Commercial License) Copyright 2025 Fonticons, Inc. --><path fill=\"currentColor\" d=\"M180.7 363.3c6.2 6.2 16.4 6.2 22.6 0l160-160c6.2-6.2 6.2-16.4 0-22.6s-16.4-6.2-22.6 0L192 329.4 43.3 180.7c-6.2-6.2-16.4-6.2-22.6 0s-6.2 16.4 0 22.6l160 160z\"\/><\/svg>\n                            <\/div>\n         \t  <div aria-hidden=\"true\" class=\"bde-faq__icon bde-faq__icon--active\">\n                                <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 384 512\"><!--! Font Awesome Pro 7.0.1 by @fontawesome - https:\/\/fontawesome.com License - https:\/\/fontawesome.com\/license (Commercial License) Copyright 2025 Fonticons, Inc. --><path fill=\"currentColor\" d=\"M180.7 148.7c6.2-6.2 16.4-6.2 22.6 0l160 160c6.2 6.2 6.2 16.4 0 22.6s-16.4 6.2-22.6 0L192 182.6 43.3 331.3c-6.2 6.2-16.4 6.2-22.6 0s-6.2-16.4 0-22.6l160-160z\"\/><\/svg>\n                            <\/div>\n                  <\/button>\n      <\/h3>\n      <div role=\"region\" aria-labelledby=\"bde-faq-101-button-1\" id=\"bde-faq-101-1\" class=\"bde-faq__answer\">\n        <div class=\"bde-faq__answer-content\">\n            <div class=\"breakdance-rich-text-styles\">\n<p>Dans les 30 jours suivant la r\u00e9ception, vous pouvez retourner les produits non ouverts et inutilis\u00e9s. Tous les scell\u00e9s, emballages et cellophans doivent \u00eatre intacts.<\/p>\n\n\n\n<p>1. T\u00e9l\u00e9chargez le formulaire de retour et remplissez-le.<br>2. Envoyez le produit avec le formulaire de retour et la facture* \u00e0 l'adresse suivante :<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><\/li>\n<\/ol>\n\n\n\n<p>Partenaire DEA<br>Ekkersrijt 4301<br>5692 DJ Son<\/p>\n\n\n\n<p><em>Vous n'avez plus la facture ? Alors contactez notre <a href=\"https:\/\/serviceshop.serviceshop.aedlab.nl\/customer-service\/\">Service \u00e0 la client\u00e8le<\/a>.<\/em><\/p>\n\n\n\n<p>AED-Partner rembourse les frais d'exp\u00e9dition si vous retournez un produit en raison d'un d\u00e9faut de fabrication, de dommages de transport ou si vous avez re\u00e7u le mauvais produit. Dans tous les autres cas, nous ne pouvons malheureusement pas rembourser les frais d'exp\u00e9dition.<\/p>\n\n\n\n<p>Nous traitons les retours dans les 2 \u00e0 3 jours suivant leur r\u00e9ception. Nous vous remboursons ensuite le montant de l'achat dans un d\u00e9lai d'une semaine. Nous effectuons toujours le remboursement via le moyen de paiement utilis\u00e9 lors de l'achat. Par exemple, si vous avez utilis\u00e9 PayPal, nous cr\u00e9diterons le compte PayPal utilis\u00e9 du montant de l'achat.<\/p>\n\n\n\n<p>N'avez-vous pas encore re\u00e7u de remboursement apr\u00e8s une semaine ? Vous pouvez contacter notre <a href=\"https:\/\/serviceshop.aedlab.nl\/fr\/service-a-la-clientele\/\">Service \u00e0 la client\u00e8le<\/a>. Nous serons alors heureux de vous aider.<\/p>\n\n\n\n<p>Souhaitez-vous retourner une commande achet\u00e9e avec un code de r\u00e9duction ? Dans ce cas, nous vous demandons de le signaler \u00e0 notre <a href=\"https:\/\/serviceshop.aedlab.nl\/fr\/service-a-la-clientele\/\">Service \u00e0 la client\u00e8le<\/a>. Vous recevrez alors un nouveau code de r\u00e9duction.<\/p>\n\n\n\n<p><\/p>\n<\/div>\n\n                    <\/div>\n      <\/div>\n    <\/div>\n  \n<\/div>    <\/article>\n    <article class=\"bde-loop-item ee-post\">\n        <div class=\"bde-frequently-asked-questions-2803-101-3220-2803-1 bde-frequently-asked-questions bde-frequently-asked-questions-2803-101\">\n      <div class=\"bde-faq__item\">\n      <h3 class=\"bde-faq__title-tag\">\n       <button id=\"bde-faq-101-button-1\" aria-expanded=\"false\" aria-controls=\"bde-faq-101-1\" class=\"bde-faq__question js-faq-item\">\n          <span class=\"bde-faq__title\">Puis-je annuler ma commande ?<\/span>\n                           <div aria-hidden=\"true\" class=\"bde-faq__icon bde-faq__icon--inactive\">\n                                <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 384 512\"><!--! Font Awesome Pro 7.0.1 by @fontawesome - https:\/\/fontawesome.com License - https:\/\/fontawesome.com\/license (Commercial License) Copyright 2025 Fonticons, Inc. --><path fill=\"currentColor\" d=\"M180.7 363.3c6.2 6.2 16.4 6.2 22.6 0l160-160c6.2-6.2 6.2-16.4 0-22.6s-16.4-6.2-22.6 0L192 329.4 43.3 180.7c-6.2-6.2-16.4-6.2-22.6 0s-6.2 16.4 0 22.6l160 160z\"\/><\/svg>\n                            <\/div>\n         \t  <div aria-hidden=\"true\" class=\"bde-faq__icon bde-faq__icon--active\">\n                                <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 384 512\"><!--! Font Awesome Pro 7.0.1 by @fontawesome - https:\/\/fontawesome.com License - https:\/\/fontawesome.com\/license (Commercial License) Copyright 2025 Fonticons, Inc. --><path fill=\"currentColor\" d=\"M180.7 148.7c6.2-6.2 16.4-6.2 22.6 0l160 160c6.2 6.2 6.2 16.4 0 22.6s-16.4 6.2-22.6 0L192 182.6 43.3 331.3c-6.2 6.2-16.4 6.2-22.6 0s-6.2-16.4 0-22.6l160-160z\"\/><\/svg>\n                            <\/div>\n                  <\/button>\n      <\/h3>\n      <div role=\"region\" aria-labelledby=\"bde-faq-101-button-1\" id=\"bde-faq-101-1\" class=\"bde-faq__answer\">\n        <div class=\"bde-faq__answer-content\">\n            <div class=\"breakdance-rich-text-styles\">\n<p>Bien s\u00fbr, vous pouvez toujours annuler une commande.<\/p>\n\n\n\n<p>N'avez-vous pas encore re\u00e7u la commande? Alors vous pouvez par t\u00e9l\u00e9phone (<a href=\"tel:+31499490016\" type=\"tel\" id=\"tel:+31499490016\" target=\"_blank\" rel=\"noreferrer noopener\">+31 (0)499 49 00 16<\/a>) par courriel (<a href=\"mailto:info@aedpartner.nl\" target=\"_blank\" rel=\"noreferrer noopener\">info@aedpartner.nl<\/a>) contacter notre service client\u00e8le.<\/p>\n\n\n\n<p>Avez-vous d\u00e9j\u00e0 re\u00e7u la commande ? Vous pouvez alors retourner la commande gratuitement.<\/p>\n<\/div>\n\n                    <\/div>\n      <\/div>\n    <\/div>\n  \n<\/div>    <\/article>\n    <article class=\"bde-loop-item ee-post\">\n        <div class=\"bde-frequently-asked-questions-2803-101-3217-2803-1 bde-frequently-asked-questions bde-frequently-asked-questions-2803-101\">\n      <div class=\"bde-faq__item\">\n      <h3 class=\"bde-faq__title-tag\">\n       <button id=\"bde-faq-101-button-1\" aria-expanded=\"false\" aria-controls=\"bde-faq-101-1\" class=\"bde-faq__question js-faq-item\">\n          <span class=\"bde-faq__title\">Wat is de Verordening Medische Hulpmiddelen (MDR)?<\/span>\n                           <div aria-hidden=\"true\" class=\"bde-faq__icon bde-faq__icon--inactive\">\n                                <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 384 512\"><!--! Font Awesome Pro 7.0.1 by @fontawesome - https:\/\/fontawesome.com License - https:\/\/fontawesome.com\/license (Commercial License) Copyright 2025 Fonticons, Inc. --><path fill=\"currentColor\" d=\"M180.7 363.3c6.2 6.2 16.4 6.2 22.6 0l160-160c6.2-6.2 6.2-16.4 0-22.6s-16.4-6.2-22.6 0L192 329.4 43.3 180.7c-6.2-6.2-16.4-6.2-22.6 0s-6.2 16.4 0 22.6l160 160z\"\/><\/svg>\n                            <\/div>\n         \t  <div aria-hidden=\"true\" class=\"bde-faq__icon bde-faq__icon--active\">\n                                <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 384 512\"><!--! Font Awesome Pro 7.0.1 by @fontawesome - https:\/\/fontawesome.com License - https:\/\/fontawesome.com\/license (Commercial License) Copyright 2025 Fonticons, Inc. --><path fill=\"currentColor\" d=\"M180.7 148.7c6.2-6.2 16.4-6.2 22.6 0l160 160c6.2 6.2 6.2 16.4 0 22.6s-16.4 6.2-22.6 0L192 182.6 43.3 331.3c-6.2 6.2-16.4 6.2-22.6 0s-6.2-16.4 0-22.6l160-160z\"\/><\/svg>\n                            <\/div>\n                  <\/button>\n      <\/h3>\n      <div role=\"region\" aria-labelledby=\"bde-faq-101-button-1\" id=\"bde-faq-101-1\" class=\"bde-faq__answer\">\n        <div class=\"bde-faq__answer-content\">\n            <div class=\"breakdance-rich-text-styles\">\n<p>De Verordening (EU) 2017\/745 betreffende Medische Hulpmiddelen is een Europese wet die in alle EU-landen geldt. Deze wet zorgt ervoor dat medische hulpmiddelen die op de Europese markt worden aangeboden, veilig zijn voor pati\u00ebnten.<\/p>\n\n\n\n<p>Deze wet wordt in de volksmond ook wel de MDR genoemd. Deze afkorting komt van de Engelse naam van deze wet: <em>R\u00e8glementation des dispositifs m\u00e9dicaux<\/em>. Alleen producten die hieraan voldoen, krijgen een MDR-certificaat.<\/p>\n\n\n\n<p>Op dit moment hebben sommige AED\u2019s nog een oud certificaat (MDD). Deze AED&#8217;s mogen nog verkocht worden tot 31 december 2027. Na 31 december 2027 mogen alleen AED&#8217;s met een nieuw certificaat (MDR) verkocht worden.<\/p>\n\n\n\n<p><em>Heb jij een AED met een MDD-certificaat? Dan mag je deze ook na 31 december 2027 blijven gebruiken.<\/em><\/p>\n\n\n\n<p><\/p>\n<\/div>\n\n                    <\/div>\n      <\/div>\n    <\/div>\n  \n<\/div>    <\/article>\n    <article class=\"bde-loop-item ee-post\">\n        <div class=\"bde-frequently-asked-questions-2803-101-3216-2803-1 bde-frequently-asked-questions bde-frequently-asked-questions-2803-101\">\n      <div class=\"bde-faq__item\">\n      <h3 class=\"bde-faq__title-tag\">\n       <button id=\"bde-faq-101-button-1\" aria-expanded=\"false\" aria-controls=\"bde-faq-101-1\" class=\"bde-faq__question js-faq-item\">\n          <span class=\"bde-faq__title\">9 belangrijke veranderingen door de MDR<\/span>\n                           <div aria-hidden=\"true\" class=\"bde-faq__icon bde-faq__icon--inactive\">\n                                <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 384 512\"><!--! Font Awesome Pro 7.0.1 by @fontawesome - https:\/\/fontawesome.com License - https:\/\/fontawesome.com\/license (Commercial License) Copyright 2025 Fonticons, Inc. --><path fill=\"currentColor\" d=\"M180.7 363.3c6.2 6.2 16.4 6.2 22.6 0l160-160c6.2-6.2 6.2-16.4 0-22.6s-16.4-6.2-22.6 0L192 329.4 43.3 180.7c-6.2-6.2-16.4-6.2-22.6 0s-6.2 16.4 0 22.6l160 160z\"\/><\/svg>\n                            <\/div>\n         \t  <div aria-hidden=\"true\" class=\"bde-faq__icon bde-faq__icon--active\">\n                                <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 384 512\"><!--! Font Awesome Pro 7.0.1 by @fontawesome - https:\/\/fontawesome.com License - https:\/\/fontawesome.com\/license (Commercial License) Copyright 2025 Fonticons, Inc. --><path fill=\"currentColor\" d=\"M180.7 148.7c6.2-6.2 16.4-6.2 22.6 0l160 160c6.2 6.2 6.2 16.4 0 22.6s-16.4 6.2-22.6 0L192 182.6 43.3 331.3c-6.2 6.2-16.4 6.2-22.6 0s-6.2-16.4 0-22.6l160-160z\"\/><\/svg>\n                            <\/div>\n                  <\/button>\n      <\/h3>\n      <div role=\"region\" aria-labelledby=\"bde-faq-101-button-1\" id=\"bde-faq-101-1\" class=\"bde-faq__answer\">\n        <div class=\"bde-faq__answer-content\">\n            <div class=\"breakdance-rich-text-styles\">\n<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>\n<\/div>\n\n                    <\/div>\n      <\/div>\n    <\/div>\n  \n<\/div>    <\/article>\n    <article class=\"bde-loop-item ee-post\">\n        <div class=\"bde-frequently-asked-questions-2803-101-3215-2803-1 bde-frequently-asked-questions bde-frequently-asked-questions-2803-101\">\n      <div class=\"bde-faq__item\">\n      <h3 class=\"bde-faq__title-tag\">\n       <button id=\"bde-faq-101-button-1\" aria-expanded=\"false\" aria-controls=\"bde-faq-101-1\" class=\"bde-faq__question js-faq-item\">\n          <span class=\"bde-faq__title\">Wat is het verschil tussen de MDR en de MDD?<\/span>\n                           <div aria-hidden=\"true\" class=\"bde-faq__icon bde-faq__icon--inactive\">\n                                <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 384 512\"><!--! Font Awesome Pro 7.0.1 by @fontawesome - https:\/\/fontawesome.com License - https:\/\/fontawesome.com\/license (Commercial License) Copyright 2025 Fonticons, Inc. --><path fill=\"currentColor\" d=\"M180.7 363.3c6.2 6.2 16.4 6.2 22.6 0l160-160c6.2-6.2 6.2-16.4 0-22.6s-16.4-6.2-22.6 0L192 329.4 43.3 180.7c-6.2-6.2-16.4-6.2-22.6 0s-6.2 16.4 0 22.6l160 160z\"\/><\/svg>\n                            <\/div>\n         \t  <div aria-hidden=\"true\" class=\"bde-faq__icon bde-faq__icon--active\">\n                                <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 384 512\"><!--! Font Awesome Pro 7.0.1 by @fontawesome - https:\/\/fontawesome.com License - https:\/\/fontawesome.com\/license (Commercial License) Copyright 2025 Fonticons, Inc. --><path fill=\"currentColor\" d=\"M180.7 148.7c6.2-6.2 16.4-6.2 22.6 0l160 160c6.2 6.2 6.2 16.4 0 22.6s-16.4 6.2-22.6 0L192 182.6 43.3 331.3c-6.2 6.2-16.4 6.2-22.6 0s-6.2-16.4 0-22.6l160-160z\"\/><\/svg>\n                            <\/div>\n                  <\/button>\n      <\/h3>\n      <div role=\"region\" aria-labelledby=\"bde-faq-101-button-1\" id=\"bde-faq-101-1\" class=\"bde-faq__answer\">\n        <div class=\"bde-faq__answer-content\">\n            <div class=\"breakdance-rich-text-styles\">\n<p>De MDR vervangt de MDD: de Medical Device Directive (<em>Richtlijn Medische Hulpmiddelen<\/em>). De MDD was een leidraad, wat betekende dat landen naast de MDD nog nationale wetgeving nodig hadden. Bij de MDR werkt dat anders. De MDR is een verordening: een wet die in alle EU-landen direct vanaf de ingangsdatum geldig en bindend is. Zo gelden overal dezelfde regels en standaarden.<\/p>\n\n\n\n<p>Alleen producten die aan de MDR voldoen, krijgen een MDR-certificaat. Op dit moment hebben sommige AED\u2019s nog een oud certificaat (MDD). Deze AED&#8217;s mogen nog verkocht worden tot 31 december 2027. Na 31 december 2027 mogen alleen AED&#8217;s met een nieuw certificaat (MDR) verkocht worden.<\/p>\n\n\n\n<p><em>Heb jij een AED met een MDD-certificaat? Dan mag je deze ook na 31 december 2027 blijven gebruiken.<\/em><\/p>\n<\/div>\n\n                    <\/div>\n      <\/div>\n    <\/div>\n  \n<\/div>    <\/article>\n    <article class=\"bde-loop-item ee-post\">\n        <div class=\"bde-frequently-asked-questions-2803-101-3214-2803-1 bde-frequently-asked-questions bde-frequently-asked-questions-2803-101\">\n      <div class=\"bde-faq__item\">\n      <h3 class=\"bde-faq__title-tag\">\n       <button id=\"bde-faq-101-button-1\" aria-expanded=\"false\" aria-controls=\"bde-faq-101-1\" class=\"bde-faq__question js-faq-item\">\n          <span class=\"bde-faq__title\">Belangrijke data rondom de MDR<\/span>\n                           <div aria-hidden=\"true\" class=\"bde-faq__icon bde-faq__icon--inactive\">\n                                <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 384 512\"><!--! Font Awesome Pro 7.0.1 by @fontawesome - https:\/\/fontawesome.com License - https:\/\/fontawesome.com\/license (Commercial License) Copyright 2025 Fonticons, Inc. --><path fill=\"currentColor\" d=\"M180.7 363.3c6.2 6.2 16.4 6.2 22.6 0l160-160c6.2-6.2 6.2-16.4 0-22.6s-16.4-6.2-22.6 0L192 329.4 43.3 180.7c-6.2-6.2-16.4-6.2-22.6 0s-6.2 16.4 0 22.6l160 160z\"\/><\/svg>\n                            <\/div>\n         \t  <div aria-hidden=\"true\" class=\"bde-faq__icon bde-faq__icon--active\">\n                                <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 384 512\"><!--! Font Awesome Pro 7.0.1 by @fontawesome - https:\/\/fontawesome.com License - https:\/\/fontawesome.com\/license (Commercial License) Copyright 2025 Fonticons, Inc. --><path fill=\"currentColor\" d=\"M180.7 148.7c6.2-6.2 16.4-6.2 22.6 0l160 160c6.2 6.2 6.2 16.4 0 22.6s-16.4 6.2-22.6 0L192 182.6 43.3 331.3c-6.2 6.2-16.4 6.2-22.6 0s-6.2-16.4 0-22.6l160-160z\"\/><\/svg>\n                            <\/div>\n                  <\/button>\n      <\/h3>\n      <div role=\"region\" aria-labelledby=\"bde-faq-101-button-1\" id=\"bde-faq-101-1\" class=\"bde-faq__answer\">\n        <div class=\"bde-faq__answer-content\">\n            <div class=\"breakdance-rich-text-styles\">\n<p><strong>5 april 2017<\/strong><br>Verordening (EU) 2017\/745 werd gepubliceerd.<\/p>\n\n\n\n<p><strong>24 april 2020<\/strong><br>Vanwege de coronapandemie werd de ingangsdatum uitgesteld tot 26 mei 2021.<\/p>\n\n\n\n<p><strong>15 maart 2023<\/strong><br>Verordening 2023\/607 trad in werking vanwege capaciteitstekorten bij de aangemelde instanties. Medische hulpmiddelen die v\u00f3\u00f3r 26 mei 2021 al op de markt werden verkocht met een MDD-certificaat, mogen onder bepaalde voorwaarden nog zonder MDR-certificering worden verkocht. Zo kregen aangemelde instanties meer tijd om medische hulpmiddelen te herbeoordelen. Fabrikanten die gebruik wilden maken van deze uitstelperiode, moesten hun hulpmiddel v\u00f3\u00f3r 26 mei 2024 bij een aangemelde instantie aangeboden en gecontracteerd hebben voor herbeoordeling.<\/p>\n\n\n\n<p>De aangemelde instantie verplicht zich de hulpmiddelen binnen een gestelde termijn te beoordelen. Voor producten in hogere risicoklassen, zoals AED&#8217;s, geldt 31 december 2027 als uiterste herbeoordelingsdatum. Voor producten in lagere risicoklassen is dat 31 december 2028.<\/p>\n\n\n\n<p><strong>26 mei 2024<br><\/strong>Hulpmiddelen zonder MDR-certificaat of verlengd MDD-certificaat, mogen niet meer op de markt aangeboden worden.<\/p>\n\n\n\n<p><strong>10 januari 2025<br><\/strong>Verordening 2024\/1860 treedt in werking<br>Fabrikanten zijn verplicht leveringsonderbrekingen van hulpmiddelen te melden. Ontvang je deze melding van de fabrikant, geef deze dan door aan de ketendeelnemers na jou.<\/p>\n\n\n\n<p><strong>31 december 2027<br><\/strong>Hulpmiddelen in de hogere risicoklassen zonder geldig MDR-certificaat mogen niet meer verkocht worden.<\/p>\n\n\n\n<p><strong>31 december 2028<br><\/strong>Hulpmiddelen in de lagere risicoklassen zonder geldig MDR-certificaat mogen niet meer verkocht worden.<\/p>\n<\/div>\n\n                    <\/div>\n      <\/div>\n    <\/div>\n  \n<\/div>    <\/article>\n    <article class=\"bde-loop-item ee-post\">\n        <div class=\"bde-frequently-asked-questions-2803-101-3213-2803-1 bde-frequently-asked-questions bde-frequently-asked-questions-2803-101\">\n      <div class=\"bde-faq__item\">\n      <h3 class=\"bde-faq__title-tag\">\n       <button id=\"bde-faq-101-button-1\" aria-expanded=\"false\" aria-controls=\"bde-faq-101-1\" class=\"bde-faq__question js-faq-item\">\n          <span class=\"bde-faq__title\">Wat merk je als marktdeelnemer van de MDR?<\/span>\n                           <div aria-hidden=\"true\" class=\"bde-faq__icon bde-faq__icon--inactive\">\n                                <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 384 512\"><!--! Font Awesome Pro 7.0.1 by @fontawesome - https:\/\/fontawesome.com License - https:\/\/fontawesome.com\/license (Commercial License) Copyright 2025 Fonticons, Inc. --><path fill=\"currentColor\" d=\"M180.7 363.3c6.2 6.2 16.4 6.2 22.6 0l160-160c6.2-6.2 6.2-16.4 0-22.6s-16.4-6.2-22.6 0L192 329.4 43.3 180.7c-6.2-6.2-16.4-6.2-22.6 0s-6.2 16.4 0 22.6l160 160z\"\/><\/svg>\n                            <\/div>\n         \t  <div aria-hidden=\"true\" class=\"bde-faq__icon bde-faq__icon--active\">\n                                <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 384 512\"><!--! Font Awesome Pro 7.0.1 by @fontawesome - https:\/\/fontawesome.com License - https:\/\/fontawesome.com\/license (Commercial License) Copyright 2025 Fonticons, Inc. --><path fill=\"currentColor\" d=\"M180.7 148.7c6.2-6.2 16.4-6.2 22.6 0l160 160c6.2 6.2 6.2 16.4 0 22.6s-16.4 6.2-22.6 0L192 182.6 43.3 331.3c-6.2 6.2-16.4 6.2-22.6 0s-6.2-16.4 0-22.6l160-160z\"\/><\/svg>\n                            <\/div>\n                  <\/button>\n      <\/h3>\n      <div role=\"region\" aria-labelledby=\"bde-faq-101-button-1\" id=\"bde-faq-101-1\" class=\"bde-faq__answer\">\n        <div class=\"bde-faq__answer-content\">\n            <div class=\"breakdance-rich-text-styles\">\n<p>De nieuwe MDR-voorschriften zijn vooral van invloed op marktdeelnemers: fabrikanten, gemachtigden, importeurs en distributeurs van medische hulpmiddelen. Onder distributeur verstaat de wet iedereen die medische hulpmiddelen verkoopt of beschikbaar stelt op de markt. Resellers van AED-Partner vallen hier ook onder.<\/p>\n\n\n\n<p>Alle marktdeelnemers moeten ervoor zorgen dat de hulpmiddelen die zij aanbieden aan de MDR-voorschriften voldoen. Jouw verplichtingen als marktdeelnemer zijn afhankelijk van jouw rol in de keten. Een uitgebreide uitleg over de verplichtingen vind je in de <a href=\"https:\/\/health.ec.europa.eu\/document\/download\/37879254-c7d6-487b-8fd9-06496e771465_nl\" target=\"_blank\" rel=\"noreferrer noopener\">offici\u00eble publicatie van de Europese Unie<\/a>.<\/p>\n<\/div>\n\n                    <\/div>\n      <\/div>\n    <\/div>\n  \n<\/div>    <\/article>\n    <article class=\"bde-loop-item ee-post\">\n        <div class=\"bde-frequently-asked-questions-2803-101-3212-2803-1 bde-frequently-asked-questions bde-frequently-asked-questions-2803-101\">\n      <div class=\"bde-faq__item\">\n      <h3 class=\"bde-faq__title-tag\">\n       <button id=\"bde-faq-101-button-1\" aria-expanded=\"false\" aria-controls=\"bde-faq-101-1\" class=\"bde-faq__question js-faq-item\">\n          <span class=\"bde-faq__title\">Wat merk je als reseller van de MDR?<\/span>\n                           <div aria-hidden=\"true\" class=\"bde-faq__icon bde-faq__icon--inactive\">\n                                <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 384 512\"><!--! Font Awesome Pro 7.0.1 by @fontawesome - https:\/\/fontawesome.com License - https:\/\/fontawesome.com\/license (Commercial License) Copyright 2025 Fonticons, Inc. --><path fill=\"currentColor\" d=\"M180.7 363.3c6.2 6.2 16.4 6.2 22.6 0l160-160c6.2-6.2 6.2-16.4 0-22.6s-16.4-6.2-22.6 0L192 329.4 43.3 180.7c-6.2-6.2-16.4-6.2-22.6 0s-6.2 16.4 0 22.6l160 160z\"\/><\/svg>\n                            <\/div>\n         \t  <div aria-hidden=\"true\" class=\"bde-faq__icon bde-faq__icon--active\">\n                                <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 384 512\"><!--! Font Awesome Pro 7.0.1 by @fontawesome - https:\/\/fontawesome.com License - https:\/\/fontawesome.com\/license (Commercial License) Copyright 2025 Fonticons, Inc. --><path fill=\"currentColor\" d=\"M180.7 148.7c6.2-6.2 16.4-6.2 22.6 0l160 160c6.2 6.2 6.2 16.4 0 22.6s-16.4 6.2-22.6 0L192 182.6 43.3 331.3c-6.2 6.2-16.4 6.2-22.6 0s-6.2-16.4 0-22.6l160-160z\"\/><\/svg>\n                            <\/div>\n                  <\/button>\n      <\/h3>\n      <div role=\"region\" aria-labelledby=\"bde-faq-101-button-1\" id=\"bde-faq-101-1\" class=\"bde-faq__answer\">\n        <div class=\"bde-faq__answer-content\">\n            <div class=\"breakdance-rich-text-styles\">\n<p>AED-Partner voldoet aan de MDR. Koop je als reseller medische hulpmiddelen bij ons voor wederverkoop? Dan gelden voor jou dezelfde verplichtingen als voor AED-Partner.<\/p>\n\n\n\n<p>Een greep uit die verplichtingen:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Bevestigen dat hulpmiddelen aan de MDR-voorschriften voldoen: staat er een CE-markering op het product, is er een conformiteitsverklaring van de fabrikant, en heeft het hulpmiddel een UDI (unieke identificatiecode)?<\/li>\n\n\n\n<li>Registers bijhouden voor onder meer klachten en incidenten.<\/li>\n\n\n\n<li>De hulpmiddelen die je verkoopt traceren: registreer aan wie je ze verkoopt, zodat je ze kunt opsporen. Hierbij gelden wettelijke bewaartermijnen voor documentatie.<\/li>\n\n\n\n<li>Medische hulpmiddelen opslaan en transporteren volgens de condities die de fabrikant opgeeft.<\/li>\n\n\n\n<li>Non-conformiteiten melden bij jouw toeleverancier. Jouw toeleverancier deelt deze informatie vervolgens met de marktdeelnemer(s) eerder in de keten.<\/li>\n\n\n\n<li>Meewerken aan corrigerende veiligheidsacties (FSCA) van de fabrikant, controles van autoriteiten en aangemelde instanties.<\/li>\n<\/ul>\n\n\n\n<p>Een uitgebreide uitleg bij alle verplichtingen vind je in de <a href=\"https:\/\/health.ec.europa.eu\/document\/download\/37879254-c7d6-487b-8fd9-06496e771465_nl\" target=\"_blank\" rel=\"noreferrer noopener\">offici\u00eble publicatie van de Europese Unie<\/a>.<\/p>\n<\/div>\n\n                    <\/div>\n      <\/div>\n    <\/div>\n  \n<\/div>    <\/article>\n    <article class=\"bde-loop-item ee-post\">\n        <div class=\"bde-frequently-asked-questions-2803-101-3211-2803-1 bde-frequently-asked-questions bde-frequently-asked-questions-2803-101\">\n      <div class=\"bde-faq__item\">\n      <h3 class=\"bde-faq__title-tag\">\n       <button id=\"bde-faq-101-button-1\" aria-expanded=\"false\" aria-controls=\"bde-faq-101-1\" class=\"bde-faq__question js-faq-item\">\n          <span class=\"bde-faq__title\">Wat merk je als eindklant van de MDR?<\/span>\n                           <div aria-hidden=\"true\" class=\"bde-faq__icon bde-faq__icon--inactive\">\n                                <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 384 512\"><!--! Font Awesome Pro 7.0.1 by @fontawesome - https:\/\/fontawesome.com License - https:\/\/fontawesome.com\/license (Commercial License) Copyright 2025 Fonticons, Inc. --><path fill=\"currentColor\" d=\"M180.7 363.3c6.2 6.2 16.4 6.2 22.6 0l160-160c6.2-6.2 6.2-16.4 0-22.6s-16.4-6.2-22.6 0L192 329.4 43.3 180.7c-6.2-6.2-16.4-6.2-22.6 0s-6.2 16.4 0 22.6l160 160z\"\/><\/svg>\n                            <\/div>\n         \t  <div aria-hidden=\"true\" class=\"bde-faq__icon bde-faq__icon--active\">\n                                <svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 384 512\"><!--! Font Awesome Pro 7.0.1 by @fontawesome - https:\/\/fontawesome.com License - https:\/\/fontawesome.com\/license (Commercial License) Copyright 2025 Fonticons, Inc. --><path fill=\"currentColor\" d=\"M180.7 148.7c6.2-6.2 16.4-6.2 22.6 0l160 160c6.2 6.2 6.2 16.4 0 22.6s-16.4 6.2-22.6 0L192 182.6 43.3 331.3c-6.2 6.2-16.4 6.2-22.6 0s-6.2-16.4 0-22.6l160-160z\"\/><\/svg>\n                            <\/div>\n                  <\/button>\n      <\/h3>\n      <div role=\"region\" aria-labelledby=\"bde-faq-101-button-1\" id=\"bde-faq-101-1\" class=\"bde-faq__answer\">\n        <div class=\"bde-faq__answer-content\">\n            <div class=\"breakdance-rich-text-styles\">\n<p>Koop of heb je een AED voor eigen gebruik? Dan verandert er door de MDR niets. Wel kun je merken dat sommige merken of modellen AED&#8217;s niet meer te koop zijn. Dit gebeurt omdat niet alle producten aan de nieuwe regels voldoen.<\/p>\n\n\n\n<p><em>Na 31 december 2027 mogen AED\u2019s zonder MDR-certificaat niet meer verkocht worden. Heb jij als eindklant een AED met een MDD-certificaat? Dan mag je deze ook na 31 december 2027 blijven gebruiken.<\/em><\/p>\n\n\n\n<p>Koop je een AED en verkoop je deze door aan iemand anders? Dan verkoop je een medisch hulpmiddel. Alle MDR-verplichtingen die voor AED-Partner als verkoper gelden, gelden dan ook voor jou als reseller.<\/p>\n\n\n\n<p>Heb je een vraag over jouw AED en de MDR? Onze medewerkers kennen de toestellen goed en geven je gratis advies. Je kunt hiervoor contact opnemen met onze <a href=\"https:\/\/serviceshop.serviceshop.aedlab.nl\/customer-service\/\">Service \u00e0 la client\u00e8le<\/a>.<\/p>\n\n\n\n<p><\/p>\n<\/div>\n\n                    <\/div>\n      <\/div>\n    <\/div>\n  \n<\/div>    <\/article>\n<\/div>\r\n<\/div>\n<\/div>\n<\/div><div class=\"bde-column-3219-120 bde-column\">\n  \n  \n\t\n\n\n\n<h3 class=\"bde-heading-3219-121 bde-heading\">\nLisez aussi :\n<\/h3><div class=\"bde-post-list-3219-122 bde-post-list\"><div class=\"bde-loop bde-loop-grid ee-posts ee-posts-grid\">    <article class=\"bde-loop-item ee-post\">\n                                <a class=\"bde-loop-item__image-link ee-post-image-link\" href=\"https:\/\/serviceshop.aedlab.nl\/fr\/kennis\/aed-onderhoud-wat-moet-je-doen-en-hoe-vaak\/\" aria-label=\"Entretien du DAE : que faire et \u00e0 quelle fr\u00e9quence ?\">\n                <div class=\"bde-loop-item__image ee-post-image\">\n                    <img loading=\"lazy\" decoding=\"async\" width=\"1200\" height=\"808\" src=\"https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/AED-Partner_servicemedewerker4-1.jpg\" class=\"attachment-full size-full wp-post-image\" alt=\"\" srcset=\"https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/AED-Partner_servicemedewerker4-1.jpg 1200w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/AED-Partner_servicemedewerker4-1-300x202.jpg 300w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/AED-Partner_servicemedewerker4-1-1024x689.jpg 1024w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/AED-Partner_servicemedewerker4-1-768x517.jpg 768w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/AED-Partner_servicemedewerker4-1-18x12.jpg 18w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/>                <\/div>\n            <\/a>\n        \n        \n        <div class=\"bde-loop-item__wrap ee-post-wrap\">\n            \n                            <h3 class=\"ee-post-title\">\n                    <a class=\"bde-loop-item__title-link ee-post-title-link\" href=\"https:\/\/serviceshop.aedlab.nl\/fr\/kennis\/aed-onderhoud-wat-moet-je-doen-en-hoe-vaak\/\" >\n                        Entretien du DAE : que faire et \u00e0 quelle fr\u00e9quence ?                    <\/a>\n                <\/h3>\n                            <div class=\"bde-loop-item__post-meta ee-post-meta\">\n                                                                                <span class=\"bde-loop-item__meta-date bde-loop-item__meta-item ee-post-meta-date ee-post-meta-item\">\n                                    16 avril 2026                                <\/span>\n                                                \n                <\/div>\n            \n            \n        <\/div>\n\n    <\/article>\n\n    <article class=\"bde-loop-item ee-post\">\n                                <a class=\"bde-loop-item__image-link ee-post-image-link\" href=\"https:\/\/serviceshop.aedlab.nl\/fr\/kennis\/waar-staat-aed-voor\/\" aria-label=\"D\u00e9fibrillateur Automatis\u00e9 Externe\">\n                <div class=\"bde-loop-item__image ee-post-image\">\n                    <img loading=\"lazy\" decoding=\"async\" width=\"1200\" height=\"800\" src=\"https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2025\/11\/AED-Partner-onderwijs.jpg\" class=\"attachment-full size-full wp-post-image\" alt=\"\" srcset=\"https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2025\/11\/AED-Partner-onderwijs.jpg 1200w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2025\/11\/AED-Partner-onderwijs-300x200.jpg 300w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2025\/11\/AED-Partner-onderwijs-1024x683.jpg 1024w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2025\/11\/AED-Partner-onderwijs-768x512.jpg 768w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2025\/11\/AED-Partner-onderwijs-18x12.jpg 18w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/>                <\/div>\n            <\/a>\n        \n        \n        <div class=\"bde-loop-item__wrap ee-post-wrap\">\n            \n                            <h3 class=\"ee-post-title\">\n                    <a class=\"bde-loop-item__title-link ee-post-title-link\" href=\"https:\/\/serviceshop.aedlab.nl\/fr\/kennis\/waar-staat-aed-voor\/\" >\n                        D\u00e9fibrillateur Automatis\u00e9 Externe                    <\/a>\n                <\/h3>\n                            <div class=\"bde-loop-item__post-meta ee-post-meta\">\n                                                                                <span class=\"bde-loop-item__meta-date bde-loop-item__meta-item ee-post-meta-date ee-post-meta-item\">\n                                    16 avril 2026                                <\/span>\n                                                \n                <\/div>\n            \n            \n        <\/div>\n\n    <\/article>\n\n    <article class=\"bde-loop-item ee-post\">\n                                <a class=\"bde-loop-item__image-link ee-post-image-link\" href=\"https:\/\/serviceshop.aedlab.nl\/fr\/kennis\/wat-kost-een-aed\/\" aria-label=\"Quel est le co\u00fbt d&#039;un DEA ?\">\n                <div class=\"bde-loop-item__image ee-post-image\">\n                    <img loading=\"lazy\" decoding=\"async\" width=\"1200\" height=\"800\" src=\"https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2025\/11\/AED-Partner-sport4.jpg\" class=\"attachment-full size-full wp-post-image\" alt=\"\" srcset=\"https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2025\/11\/AED-Partner-sport4.jpg 1200w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2025\/11\/AED-Partner-sport4-300x200.jpg 300w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2025\/11\/AED-Partner-sport4-1024x683.jpg 1024w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2025\/11\/AED-Partner-sport4-768x512.jpg 768w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2025\/11\/AED-Partner-sport4-18x12.jpg 18w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/>                <\/div>\n            <\/a>\n        \n        \n        <div class=\"bde-loop-item__wrap ee-post-wrap\">\n            \n                            <h3 class=\"ee-post-title\">\n                    <a class=\"bde-loop-item__title-link ee-post-title-link\" href=\"https:\/\/serviceshop.aedlab.nl\/fr\/kennis\/wat-kost-een-aed\/\" >\n                        Quel est le co\u00fbt d'un DEA ?                    <\/a>\n                <\/h3>\n                            <div class=\"bde-loop-item__post-meta ee-post-meta\">\n                                                                                <span class=\"bde-loop-item__meta-date bde-loop-item__meta-item ee-post-meta-date ee-post-meta-item\">\n                                    16 avril 2026                                <\/span>\n                                                \n                <\/div>\n            \n            \n        <\/div>\n\n    <\/article>\n\n    <article class=\"bde-loop-item ee-post\">\n                                <a class=\"bde-loop-item__image-link ee-post-image-link\" href=\"https:\/\/serviceshop.aedlab.nl\/fr\/kennis\/wanneer-moet-je-de-batterij-van-een-aed-vervangen\/\" aria-label=\"Quand faut-il remplacer la batterie d&#039;un DAE ?\">\n                <div class=\"bde-loop-item__image ee-post-image\">\n                    <img loading=\"lazy\" decoding=\"async\" width=\"1573\" height=\"1080\" src=\"https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/AED-Partner_servicemedewerker3.jpg\" class=\"attachment-full size-full wp-post-image\" alt=\"\" srcset=\"https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/AED-Partner_servicemedewerker3.jpg 1573w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/AED-Partner_servicemedewerker3-300x206.jpg 300w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/AED-Partner_servicemedewerker3-1024x703.jpg 1024w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/AED-Partner_servicemedewerker3-768x527.jpg 768w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/AED-Partner_servicemedewerker3-1536x1055.jpg 1536w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/AED-Partner_servicemedewerker3-18x12.jpg 18w\" sizes=\"auto, (max-width: 1573px) 100vw, 1573px\" \/>                <\/div>\n            <\/a>\n        \n        \n        <div class=\"bde-loop-item__wrap ee-post-wrap\">\n            \n                            <h3 class=\"ee-post-title\">\n                    <a class=\"bde-loop-item__title-link ee-post-title-link\" href=\"https:\/\/serviceshop.aedlab.nl\/fr\/kennis\/wanneer-moet-je-de-batterij-van-een-aed-vervangen\/\" >\n                        Quand faut-il remplacer la batterie d'un DAE ?                    <\/a>\n                <\/h3>\n                            <div class=\"bde-loop-item__post-meta ee-post-meta\">\n                                                                                <span class=\"bde-loop-item__meta-date bde-loop-item__meta-item ee-post-meta-date ee-post-meta-item\">\n                                    16 avril 2026                                <\/span>\n                                                \n                <\/div>\n            \n            \n        <\/div>\n\n    <\/article>\n\n<\/div><\/div><div class=\"bde-post-list-3219-123 bde-post-list\"><div class=\"breakdance-swiper-wrapper\" data-swiper-id=\"123\"><div class=\"swiper\"><div class=\"bde-loop bde-loop-slider ee-posts ee-posts-slider swiper-wrapper\">    <article class=\"bde-loop-item ee-post swiper-slide\">\n                                <a class=\"bde-loop-item__image-link ee-post-image-link\" href=\"https:\/\/serviceshop.aedlab.nl\/fr\/kennis\/aed-onderhoud-wat-moet-je-doen-en-hoe-vaak\/\" aria-label=\"Entretien du DAE : que faire et \u00e0 quelle fr\u00e9quence ?\">\n                <div class=\"bde-loop-item__image ee-post-image\">\n                    <img loading=\"lazy\" decoding=\"async\" width=\"1200\" height=\"808\" src=\"https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/AED-Partner_servicemedewerker4-1.jpg\" class=\"attachment-full size-full wp-post-image\" alt=\"\" srcset=\"https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/AED-Partner_servicemedewerker4-1.jpg 1200w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/AED-Partner_servicemedewerker4-1-300x202.jpg 300w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/AED-Partner_servicemedewerker4-1-1024x689.jpg 1024w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/AED-Partner_servicemedewerker4-1-768x517.jpg 768w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/AED-Partner_servicemedewerker4-1-18x12.jpg 18w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/>                <\/div>\n            <\/a>\n        \n        \n        <div class=\"bde-loop-item__wrap ee-post-wrap\">\n            \n                            <h3 class=\"ee-post-title\">\n                    <a class=\"bde-loop-item__title-link ee-post-title-link\" href=\"https:\/\/serviceshop.aedlab.nl\/fr\/kennis\/aed-onderhoud-wat-moet-je-doen-en-hoe-vaak\/\" >\n                        Entretien du DAE : que faire et \u00e0 quelle fr\u00e9quence ?                    <\/a>\n                <\/h3>\n                            <div class=\"bde-loop-item__post-meta ee-post-meta\">\n                                                                                <span class=\"bde-loop-item__meta-date bde-loop-item__meta-item ee-post-meta-date ee-post-meta-item\">\n                                    16 avril 2026                                <\/span>\n                                                \n                <\/div>\n            \n            \n        <\/div>\n\n    <\/article>\n\n    <article class=\"bde-loop-item ee-post swiper-slide\">\n                                <a class=\"bde-loop-item__image-link ee-post-image-link\" href=\"https:\/\/serviceshop.aedlab.nl\/fr\/kennis\/waar-staat-aed-voor\/\" aria-label=\"D\u00e9fibrillateur Automatis\u00e9 Externe\">\n                <div class=\"bde-loop-item__image ee-post-image\">\n                    <img loading=\"lazy\" decoding=\"async\" width=\"1200\" height=\"800\" src=\"https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2025\/11\/AED-Partner-onderwijs.jpg\" class=\"attachment-full size-full wp-post-image\" alt=\"\" srcset=\"https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2025\/11\/AED-Partner-onderwijs.jpg 1200w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2025\/11\/AED-Partner-onderwijs-300x200.jpg 300w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2025\/11\/AED-Partner-onderwijs-1024x683.jpg 1024w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2025\/11\/AED-Partner-onderwijs-768x512.jpg 768w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2025\/11\/AED-Partner-onderwijs-18x12.jpg 18w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/>                <\/div>\n            <\/a>\n        \n        \n        <div class=\"bde-loop-item__wrap ee-post-wrap\">\n            \n                            <h3 class=\"ee-post-title\">\n                    <a class=\"bde-loop-item__title-link ee-post-title-link\" href=\"https:\/\/serviceshop.aedlab.nl\/fr\/kennis\/waar-staat-aed-voor\/\" >\n                        D\u00e9fibrillateur Automatis\u00e9 Externe                    <\/a>\n                <\/h3>\n                            <div class=\"bde-loop-item__post-meta ee-post-meta\">\n                                                                                <span class=\"bde-loop-item__meta-date bde-loop-item__meta-item ee-post-meta-date ee-post-meta-item\">\n                                    16 avril 2026                                <\/span>\n                                                \n                <\/div>\n            \n            \n        <\/div>\n\n    <\/article>\n\n    <article class=\"bde-loop-item ee-post swiper-slide\">\n                                <a class=\"bde-loop-item__image-link ee-post-image-link\" href=\"https:\/\/serviceshop.aedlab.nl\/fr\/kennis\/wat-kost-een-aed\/\" aria-label=\"Quel est le co\u00fbt d&#039;un DEA ?\">\n                <div class=\"bde-loop-item__image ee-post-image\">\n                    <img loading=\"lazy\" decoding=\"async\" width=\"1200\" height=\"800\" src=\"https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2025\/11\/AED-Partner-sport4.jpg\" class=\"attachment-full size-full wp-post-image\" alt=\"\" srcset=\"https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2025\/11\/AED-Partner-sport4.jpg 1200w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2025\/11\/AED-Partner-sport4-300x200.jpg 300w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2025\/11\/AED-Partner-sport4-1024x683.jpg 1024w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2025\/11\/AED-Partner-sport4-768x512.jpg 768w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2025\/11\/AED-Partner-sport4-18x12.jpg 18w\" sizes=\"auto, (max-width: 1200px) 100vw, 1200px\" \/>                <\/div>\n            <\/a>\n        \n        \n        <div class=\"bde-loop-item__wrap ee-post-wrap\">\n            \n                            <h3 class=\"ee-post-title\">\n                    <a class=\"bde-loop-item__title-link ee-post-title-link\" href=\"https:\/\/serviceshop.aedlab.nl\/fr\/kennis\/wat-kost-een-aed\/\" >\n                        Quel est le co\u00fbt d'un DEA ?                    <\/a>\n                <\/h3>\n                            <div class=\"bde-loop-item__post-meta ee-post-meta\">\n                                                                                <span class=\"bde-loop-item__meta-date bde-loop-item__meta-item ee-post-meta-date ee-post-meta-item\">\n                                    16 avril 2026                                <\/span>\n                                                \n                <\/div>\n            \n            \n        <\/div>\n\n    <\/article>\n\n    <article class=\"bde-loop-item ee-post swiper-slide\">\n                                <a class=\"bde-loop-item__image-link ee-post-image-link\" href=\"https:\/\/serviceshop.aedlab.nl\/fr\/kennis\/medical-device-regulation\/\" aria-label=\"R\u00e8glementation des dispositifs m\u00e9dicaux\">\n                <div class=\"bde-loop-item__image ee-post-image\">\n                    <img loading=\"lazy\" decoding=\"async\" width=\"1600\" height=\"1112\" src=\"https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/MDR-AED-Partner.jpg\" class=\"attachment-full size-full wp-post-image\" alt=\"\" srcset=\"https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/MDR-AED-Partner.jpg 1600w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/MDR-AED-Partner-300x209.jpg 300w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/MDR-AED-Partner-1024x712.jpg 1024w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/MDR-AED-Partner-768x534.jpg 768w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/MDR-AED-Partner-1536x1068.jpg 1536w, https:\/\/serviceshop.aedlab.nl\/wp-content\/uploads\/2026\/04\/MDR-AED-Partner-18x12.jpg 18w\" sizes=\"auto, (max-width: 1600px) 100vw, 1600px\" \/>                <\/div>\n            <\/a>\n        \n        \n        <div class=\"bde-loop-item__wrap ee-post-wrap\">\n            \n                            <h3 class=\"ee-post-title\">\n                    <a class=\"bde-loop-item__title-link ee-post-title-link\" href=\"https:\/\/serviceshop.aedlab.nl\/fr\/kennis\/medical-device-regulation\/\" >\n                        R\u00e8glementation des dispositifs m\u00e9dicaux                    <\/a>\n                <\/h3>\n                            <div class=\"bde-loop-item__post-meta ee-post-meta\">\n                                                                                <span class=\"bde-loop-item__meta-date bde-loop-item__meta-item ee-post-meta-date ee-post-meta-item\">\n                                    avril 8, 2026                                <\/span>\n                                                \n                <\/div>\n            \n            \n        <\/div>\n\n    <\/article>\n\n<\/div><\/div>\n    \n    \n<\/div><\/div>\n<\/div><\/div><\/div>\n<\/section>","protected":false},"featured_media":3224,"template":"","meta":{"_acf_changed":true,"_breakdance_hide_in_design_set":false,"_breakdance_tags":""},"soort":[2],"class_list":["post-3219","kennis","type-kennis","status-publish","has-post-thumbnail","hentry","soort-kennis"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Medical Device Regulation - 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=\"Medical Device Regulation - AED-partner\" \/>\n<meta property=\"og:description\" content=\"Bekijk alle kennis &amp; nieuws Medical Device Regulation De Medical Device Regulation (MDR) is een Europese wet voor medische hulpmiddelen. Deze wet zorgt dat medische hulpmiddelen die op de Europese markt worden aangeboden, veilig zijn voor pati\u00ebnten. De Nederlandse naam van deze wet is de Verordening Medische Hulpmiddelen. 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