{"id":3540,"date":"2025-06-12T10:48:15","date_gmt":"2025-06-12T10:48:15","guid":{"rendered":"https:\/\/operonstrategist.com\/en-nl\/?p=3540"},"modified":"2025-07-02T09:12:25","modified_gmt":"2025-07-02T09:12:25","slug":"ce-marking-for-software-as-a-medical-device-samd-in-the-netherlands","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/en-nl\/ce-marking-for-software-as-a-medical-device-samd-in-the-netherlands\/","title":{"rendered":"CE Marking for Software as a Medical Device (SaMD) in the Netherlands"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"3540\" class=\"elementor elementor-3540\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6da65d3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6da65d3\" 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-81d2d42\" data-id=\"81d2d42\" 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-df8e2c0 elementor-widget elementor-widget-heading\" data-id=\"df8e2c0\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Introduction\n\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ba04bcf elementor-widget elementor-widget-text-editor\" data-id=\"ba04bcf\" 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 data-start=\"498\" data-end=\"859\">As digital healthcare solutions evolve, Software as a Medical Device (SaMD) has become a crucial innovation in modern medicine. Whether it&#8217;s a diagnostic app, AI-based imaging software, or a remote monitoring tool, if you&#8217;re planning to launch SaMD in the European Union (EU)\u2014particularly in the Netherlands\u2014you need to ensure CE Marking compliance.<\/p><p data-start=\"861\" data-end=\"1048\">In this blog, we\u2019ll break down what CE Marking means for SaMD, the regulatory steps involved, and how to bring your medical software to market in the Netherlands smoothly and compliantly.<\/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 class=\"elementor-section elementor-top-section elementor-element elementor-element-db4dbab elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"db4dbab\" 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-8ee2aad\" data-id=\"8ee2aad\" 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-53b72e0 elementor-widget elementor-widget-heading\" data-id=\"53b72e0\" 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<h2 class=\"elementor-heading-title elementor-size-default\">What is CE Marking?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1026359 elementor-widget elementor-widget-text-editor\" data-id=\"1026359\" 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 data-start=\"1080\" data-end=\"1364\">CE Marking is a certification mark that confirms a product\u2019s compliance with EU safety, health, and environmental protection standards. For medical devices, including SaMD, it indicates that the product meets the Medical Device Regulation (EU) 2017\/745 (MDR) requirements.<\/p><p data-start=\"1366\" data-end=\"1481\">Without CE Marking, you cannot legally market or sell your medical device in the EU, including the Netherlands.<\/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 class=\"elementor-section elementor-top-section elementor-element elementor-element-e352427 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"e352427\" 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-2f0dda0\" data-id=\"2f0dda0\" 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-180385a elementor-widget elementor-widget-heading\" data-id=\"180385a\" 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<h2 class=\"elementor-heading-title elementor-size-default\">What is Software as a Medical Device (SaMD)?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-dc98abd elementor-widget elementor-widget-text-editor\" data-id=\"dc98abd\" 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 data-start=\"1538\" data-end=\"1720\">Software as a Medical Device refers to software that is intended to be used for medical purposes without being part of a hardware medical device. This includes software that:<\/p><ul><li data-start=\"1724\" data-end=\"1765\">Diagnoses or monitors a medical condition<\/li><li data-start=\"1768\" data-end=\"1800\">Provides therapy recommendations<\/li><li data-start=\"1803\" data-end=\"1855\">Analyses or processes medical images or patient data<\/li><\/ul><p data-start=\"1857\" data-end=\"1993\">If your software performs any medical function, it likely qualifies as SaMD under the EU MDR and must go through the CE Marking process.<\/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 class=\"elementor-section elementor-top-section elementor-element elementor-element-2dabda5 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2dabda5\" 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-36d4498\" data-id=\"36d4498\" 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-10fa941 elementor-widget elementor-widget-heading\" data-id=\"10fa941\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Why CE Marking Matters for SaMD in the Netherlands\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d2f2d3e elementor-widget elementor-widget-text-editor\" data-id=\"d2f2d3e\" 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 data-start=\"2056\" data-end=\"2239\">The Netherlands is a hub for digital health startups and medical technology innovation. However, to gain market access, manufacturers must navigate strict regulatory pathways.<\/p><p data-start=\"2241\" data-end=\"2269\">CE Marking for SaMD ensures:<\/p><ul><li data-start=\"2273\" data-end=\"2328\">Legal market entry in the Netherlands and across the EU<\/li><li data-start=\"2331\" data-end=\"2382\">Increased trust from healthcare providers and users<\/li><li data-start=\"2385\" data-end=\"2418\">Reduced legal and financial risks<\/li><\/ul>\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 class=\"elementor-section elementor-top-section elementor-element elementor-element-d33b982 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"d33b982\" 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-bd601d7\" data-id=\"bd601d7\" 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-b67cee9 elementor-widget elementor-widget-heading\" data-id=\"b67cee9\" 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<h2 class=\"elementor-heading-title elementor-size-default\">CE Marking Process for Software as a Medical Device (SaMD)\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8c7c009 elementor-widget elementor-widget-text-editor\" data-id=\"8c7c009\" 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<h6 data-start=\"2489\" data-end=\"2538\">1. Determine Classification Under EU MDR<\/h6><p data-start=\"2539\" data-end=\"2712\">Under MDR, SaMD is classified based on risk level into Class I, IIa, IIb, or III. Most SaMDs fall under Class IIa or higher, requiring Notified Body involvement.<\/p><h6 data-start=\"2714\" data-end=\"2760\">2. Define the Intended Use and Claims<\/h6><p data-start=\"2761\" data-end=\"2932\">Clearly define the intended use, target users, and medical claims of your software. This forms the basis for classification, clinical evaluation, and labeling.<\/p><h6 data-start=\"2934\" data-end=\"2975\">3. Conduct a Clinical Evaluation<\/h6><p data-start=\"2976\" data-end=\"3136\">Prepare a Clinical Evaluation Report (CER) using clinical data, literature reviews, and\/or studies demonstrating safety and performance of the software.<\/p><h6 data-start=\"3138\" data-end=\"3193\">4. Implement a Quality Management System (QMS)<\/h6><p data-start=\"3194\" data-end=\"3320\">CE Marking for SaMD requires a robust QMS such as <a href=\"https:\/\/operonstrategist.com\/services\/turnkey-project\/quality-management-system\/iso-13485\/\">ISO 13485<\/a> to manage development, risk, and post-market surveillance.<\/p><h6 data-start=\"3322\" data-end=\"3357\">5. Perform Risk Management<\/h6><p data-start=\"3358\" data-end=\"3501\">Conduct risk analysis in accordance with ISO 14971, identifying potential hazards, evaluating risks, and implementing control measures.<\/p><h6 data-start=\"3503\" data-end=\"3550\">6. Technical Documentation Preparation<\/h6><p data-start=\"3551\" data-end=\"3615\">Compile comprehensive technical documentation that includes:<\/p><ul><li data-start=\"3619\" data-end=\"3651\">Software design and architecture<\/li><li data-start=\"3654\" data-end=\"3676\">Cybersecurity measures<\/li><li data-start=\"3679\" data-end=\"3711\">Verification and validation data<\/li><li data-start=\"3714\" data-end=\"3753\">Labeling and Instructions for Use (IFU)<\/li><\/ul><h6 data-start=\"3755\" data-end=\"3826\">7. Appoint an EU Authorized Representative (If Outside the EU)<\/h6><p data-start=\"3827\" data-end=\"3968\">Non-EU manufacturers must appoint a Dutch or EU-based Authorized Representative to act as a legal liaison with EU regulatory authorities.<\/p><h6 data-start=\"3970\" data-end=\"4021\">8. Involve a Notified Body (If Applicable)<\/h6><p data-start=\"4022\" data-end=\"4141\">For Class IIa and higher SaMDs, submit your technical file to a Notified Body for review and conformity assessment.<\/p><h6 data-start=\"4143\" data-end=\"4196\">9. Declaration of Conformity &amp; Affix CE Mark<\/h6><p data-start=\"4197\" data-end=\"4369\">Once your product complies with all relevant requirements, issue a Declaration of Conformity (DoC) and affix the CE Mark on your software product and documentation.<\/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 class=\"elementor-section elementor-top-section elementor-element elementor-element-08bc03e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"08bc03e\" 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-e1d6f6c\" data-id=\"e1d6f6c\" 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-b0966ba elementor-widget elementor-widget-heading\" data-id=\"b0966ba\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Post-Market Requirements in the Netherlands\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-890b260 elementor-widget elementor-widget-text-editor\" data-id=\"890b260\" 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 data-start=\"4425\" data-end=\"4522\">After obtaining CE Marking, you must comply with ongoing post-market surveillance, including:<\/p><ul><li data-start=\"4526\" data-end=\"4563\">Periodic Safety Update Reports (PSUR)<\/li><li data-start=\"4566\" data-end=\"4585\">Vigilance reporting<\/li><li data-start=\"4588\" data-end=\"4637\">Software updates and change control documentation<\/li><li data-start=\"4640\" data-end=\"4679\">User feedback and complaints management<\/li><\/ul>\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 class=\"elementor-section elementor-top-section elementor-element elementor-element-bde6d0f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"bde6d0f\" 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-1c0cf3d\" data-id=\"1c0cf3d\" 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-bb9b143 elementor-widget elementor-widget-heading\" data-id=\"bb9b143\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Common Challenges in CE Marking for SaMD<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-570f95e elementor-widget elementor-widget-text-editor\" data-id=\"570f95e\" 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<ul><li data-start=\"4734\" data-end=\"4786\">Interpreting MDR classification rules for software<\/li><li data-start=\"4789\" data-end=\"4854\">Demonstrating clinical performance without physical interaction<\/li><li data-start=\"4857\" data-end=\"4919\">Keeping up with evolving cybersecurity and AI\/ML regulations<\/li><li data-start=\"4922\" data-end=\"4975\">Managing frequent software updates and change control<\/li><\/ul><p data-start=\"4977\" data-end=\"5113\">Working with a regulatory consultant experienced in <a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/ce-marking\/\">CE Marking<\/a> for SaMD in the Netherlands can help you navigate these complexities.<\/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 class=\"elementor-section elementor-top-section elementor-element elementor-element-e217ed1 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"e217ed1\" 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-025b11b\" data-id=\"025b11b\" 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-456b534 elementor-widget elementor-widget-heading\" data-id=\"456b534\" 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<h2 class=\"elementor-heading-title elementor-size-default\">How Operon Strategist Can Help<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-46ad380 elementor-widget elementor-widget-text-editor\" data-id=\"46ad380\" 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 data-start=\"5156\" data-end=\"5356\">At Operon Strategist, we specialize in guiding SaMD manufacturers through the CE Marking process, ensuring compliance with MDR and smooth market entry in the Netherlands and across the EU.<\/p><p data-start=\"5358\" data-end=\"5379\"><strong>Our services include:<\/strong><\/p><ul><li data-start=\"5383\" data-end=\"5428\">SaMD classification and regulatory strategy<\/li><li data-start=\"5431\" data-end=\"5469\">Technical file and <a href=\"https:\/\/operonstrategist.com\/services\/turnkey-project\/quality-management-system\/\">QMS<\/a> documentation<\/li><li data-start=\"5472\" data-end=\"5501\">Clinical evaluation support<\/li><li data-start=\"5504\" data-end=\"5532\">Notified Body coordination<\/li><li data-start=\"5535\" data-end=\"5568\">Post-market compliance assistance<\/li><\/ul><p data-start=\"5906\" data-end=\"6060\">If you&#8217;re ready to start the <a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/ce-marking\/\">CE Marking<\/a> process for your SaMD, <a class=\"\" href=\"https:\/\/operonstrategist.com\/contact-us\/\" target=\"_new\" rel=\"noopener\" data-start=\"5969\" data-end=\"6025\">contact our experts<\/a> for end-to-end regulatory support.<\/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<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Introduction As digital healthcare solutions evolve, Software as a Medical Device (SaMD) has become a crucial innovation in modern medicine. Whether it&#8217;s a diagnostic app, AI-based imaging software, or a remote monitoring tool, if you&#8217;re planning to launch SaMD in the European Union (EU)\u2014particularly in the Netherlands\u2014you need to ensure CE Marking compliance. 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