{"id":3305,"date":"2025-06-10T15:37:53","date_gmt":"2025-06-10T12:07:53","guid":{"rendered":"https:\/\/iranhealth.org\/en\/?p=3305"},"modified":"2025-06-15T15:39:33","modified_gmt":"2025-06-15T12:09:33","slug":"three-step-ce-certification-process-for-medical-devices-with-focus-on-new-mdr-requirements","status":"publish","type":"post","link":"https:\/\/iranhealth.org\/en\/three-step-ce-certification-process-for-medical-devices-with-focus-on-new-mdr-requirements\/","title":{"rendered":"Three-Step CE Certification Process for Medical Devices with Focus on New MDR Requirements"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"3305\" class=\"elementor elementor-3305\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b2690e9 e-flex e-con-boxed e-con e-parent\" data-id=\"b2690e9\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-64a3b99 elementor-widget elementor-widget-heading\" data-id=\"64a3b99\" data-element_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\"><span>Three-Step CE Certification Process for Medical Devices with Focus on New MDR Requirements<\/span><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1cc6141 elementor-widget elementor-widget-text-editor\" data-id=\"1cc6141\" data-element_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 style=\"margin:0in;margin-bottom:.0001pt;text-align:justify\">June 10, 2025 \u2013 The CE certification process for\nmedical devices, particularly under the latest Medical Device Regulation (MDR)\nof the European Union, now follows a stringent three-phase approach. Diego Stivanella,\nRegional Manager of ECM, shared that their company, with over 20 years of\nglobal experience as a notified body, oversees certification processes for\nmanufacturers worldwide (excluding the US and China), ensuring compliance with\ninternational standards.<\/p><p style=\"margin:0in;margin-bottom:.0001pt;text-align:justify\">The three phases of CE certification under MDR are:<\/p><p style=\"margin:0in;margin-bottom:.0001pt;text-align:justify\"><strong>Phase One:<\/strong> Submission of\nthe initial application, collection of basic information, and signing of the\nagreement.<br>\n<strong>Phase Two:<\/strong> Provision of comprehensive\ndocumentation, detailed review of technical files, and notification of related\ncosts.<br>\n<strong>Phase Three:<\/strong> On-site audit and completion of the\nfinal conformity assessment. After a thorough review of all technical\ndocumentation and successful audit, the CE certificate is issued.<\/p><p style=\"margin:0in;margin-bottom:.0001pt;text-align:justify\">The issued certificate is valid for five years, with\nperiodic engineering reviews during this period to ensure continuous compliance\nwith updated requirements. These reviews are conducted under the supervision of\nEuropean authorities.<\/p><p style=\"margin:0in;margin-bottom:.0001pt;text-align:justify\">Stivanella emphasized that, compared to the previous Medical\nDevices Directive (MDD), the MDR has introduced stricter requirements, more\nannexes, and a much greater focus on rigorous testing and product safety. For\ninstance, while the term \u201csafety\u201d appeared only 40 times in the MDD, it is\nreferenced over 290 times in the MDR. As a result, the MDR certification\nprocess can take up to four times longer than under MDD.<\/p><p style=\"margin:0in;margin-bottom:.0001pt;text-align:justify\">Products certified under MDD must be re-evaluated and\nupdated to meet MDR requirements for new certification. Stivanella highlighted\nthat understanding these changes is crucial for sustained and successful entry\ninto international markets, and ECM offers tailored strategies to expedite\ncertification when immediate market entry is required.<\/p><p style=\"margin:0in;margin-bottom:.0001pt;text-align:justify\">The goal remains to help manufacturers enter global\nmarkets quickly and safely by ensuring that all products comply with the latest\nEuropean standards, supporting long-term market access and patient safety.<\/p><p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n<\/p><p class=\"MsoNormal\">&nbsp;<\/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\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Three-Step CE Certification Process for Medical Devices with Focus on New MDR Requirements June 10, &#8230; <a class=\"cz_readmore\" href=\"https:\/\/iranhealth.org\/en\/three-step-ce-certification-process-for-medical-devices-with-focus-on-new-mdr-requirements\/\"><i class=\"fa czico-063-menu-2\" aria-hidden=\"true\"><\/i><span>Read More<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[16],"tags":[102,82],"class_list":["post-3305","post","type-post","status-publish","format-standard","hentry","category-news","tag-2025-jun-10","tag-iranhealth2025"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v24.3 (Yoast SEO v26.6) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Three-Step CE Certification Process for Medical Devices with Focus on New MDR Requirements - Iranhealth International Exhibition<\/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:\/\/iranhealth.org\/en\/three-step-ce-certification-process-for-medical-devices-with-focus-on-new-mdr-requirements\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Three-Step CE Certification Process for Medical Devices with Focus on New MDR Requirements\" \/>\n<meta property=\"og:description\" content=\"Three-Step CE Certification Process for Medical Devices with Focus on New MDR Requirements June 10, ... 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