{"id":3913,"date":"2026-05-25T09:13:56","date_gmt":"2026-05-25T06:13:56","guid":{"rendered":"http:\/\/sw-themes.com\/porto_dummy\/?post_type=event&p=3913"},"modified":"2026-06-22T12:21:00","modified_gmt":"2026-06-22T09:21:00","slug":"class-3-drug-device-combinations","status":"publish","type":"event","link":"https:\/\/demo.erayonetim.com\/en\/hizmetlerimiz\/sinif-3-ilacli-tibbi-cihazlar\/","title":{"rendered":"Class III Medical Devices"},"content":{"rendered":"
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\ud83d\udcc2 Class III Pharmaceutical Devices and DMF Consulting<\/h4>\n

\u0130la\u00e7 \u0130\u00e7eren T\u0131bbi Cihazlar\u0131n\u0131z \u0130\u00e7in Reg\u00fclasyon ve Dosya Haz\u0131rl\u0131k Deste\u011fi (MDR Ek VIII, Kural 14 & Madde 117)<\/h4>\n
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\ud83d\udccc Quick Facts Box:<\/h5>\n
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  • \ud83d\udd39 Does your device contain a medication that has a systemic effect?<\/li>\n
  • \ud83d\udd39 Is the pharmaceutical substance an integral part of the device?<\/li>\n
  • \ud83d\udd39 Is a consultation procedure required from the competent authority during the approval process?<\/li>\n<\/ul>\n<\/div>\n

    If your answer is \u201cyes,\u201d your product is likely a Class III medicinal device containing medication, which falls under Rule 14 of the MDR. Standard technical file preparation may be insufficient for these devices. Under MDR 2017\/745, medical devices that deliver or administer a drug in a way that produces a systemic effect are classified as Class III under Rule 14 and are subject to both medical device and drug regulations.<\/p>\n

    Era Management offers regulatory compliance strategy development, technical file preparation, and DMF (Drug Master File) support for your pharmaceutical medical devices.<\/p>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/div><\/div>

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    Our Scope of Services<\/h3>\n
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    • \u203a<\/span>Product class verification under Rule 14 of Annex VIII of the MDR.<\/li>\n
    • \u203a<\/span>Establishing a regulatory strategy regarding drug content (MD\u2013MP borderline)<\/li>\n
    • \u203a<\/span>EMA or national authority consultation procedure support<\/li>\n
    • \u203a<\/span>Preparation of necessary pharmaceutical quality and safety data for the drug component.<\/li>\n
    • \u203a<\/span>Preparation or procurement of the DMF (Drug Master File)<\/li>\n
    • \u203a<\/span>Managing collaboration processes with the manufacturer\/supplier of the active substance.<\/li>\n
    • \u203a<\/span>Integration of drug-related sections into the technical file (Annexes II and III).<\/li>\n
    • \u203a<\/span>Communication management with approved bodies and competent authorities.<\/li>\n<\/ul>\n<\/div>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/div>
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      DMF (Drug Master File) Support<\/h3>\n

      For drug-containing devices, data on the quality and safety of the active ingredient must be presented in a DMF (or equivalent data pack). We:<\/p>\n

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      • \u2022<\/span>We enable the use of an existing DMF in the appropriate format.<\/li>\n
      • \u2022<\/span>If it's missing, we'll prepare a new DMF on your behalf or coordinate with the manufacturer.<\/li>\n
      • \u2022<\/span>We manage confidential information sharing processes (LoA, restricted access partitions, etc.).<\/li>\n<\/ul>\n

        Why is this service important?<\/h3>\n
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        • \u2022 Drug-assisted devices are classified in the highest risk category under the MDR.<\/li>\n
        • \u2022 The competent authority consultation process (Article 117) complicates the product approval process.<\/li>\n
        • \u2022 Delay in the approval process due to incorrect or incomplete filing.<\/li>\n
        • \u2022 The difficulties of preparing a technical file without sufficient knowledge of pharmaceutical regulations.<\/li>\n<\/ul>\n<\/div>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/div><\/div>
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          \u2705 Why Era Management?<\/h3>\n
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          \u25cf<\/span>One of the rare consulting firms that takes a holistic approach to medical device and drug regulations.<\/div>\n
          \u25cf<\/span>Expert team familiar with DMF structure and pharmaceutical data requirements.<\/div>\n
          \u25cf<\/span>Strategic technical file management specific to CE certification processes.<\/div>\n
          \u25cf<\/span>Consultant team experienced in communication with approved bodies and authorities.<\/div>\n<\/div>\n
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          \ud83d\udcde Contact Us Now!<\/h4>\n

          \u27a1 Does your product fall under Rule 14?<\/p>\n

          \u27a1 Do you need to prepare for the consultation process?<\/p>\n

          \u27a1 What to do if there is no DMF? Consult with our experts to create a strategy tailored to your needs.<\/p>\n<\/div>\n<\/div>\n\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/div>

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          \"\"<\/div>\r\n\t\t<\/div>\r\n\t<\/div>\r\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n<\/div>","protected":false},"excerpt":{"rendered":"

          En y\u00fcksek risk grubunda yer alan ila\u00e7l\u0131 t\u0131bbi cihazlar\u0131n klinik de\u011ferlendirmeleri, tasar\u0131m onay s\u00fcre\u00e7leri ve reg\u00fclasyonel dosyalamalar\u0131 i\u00e7in en \u00fcst seviyede teknik uzmanl\u0131k ve rehberlik sunuyoruz.<\/p>","protected":false},"featured_media":4295,"menu_order":0,"template":"","class_list":["post-3913","event","type-event","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/demo.erayonetim.com\/en\/wp-json\/wp\/v2\/event\/3913","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/demo.erayonetim.com\/en\/wp-json\/wp\/v2\/event"}],"about":[{"href":"https:\/\/demo.erayonetim.com\/en\/wp-json\/wp\/v2\/types\/event"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/demo.erayonetim.com\/en\/wp-json\/wp\/v2\/media\/4295"}],"wp:attachment":[{"href":"https:\/\/demo.erayonetim.com\/en\/wp-json\/wp\/v2\/media?parent=3913"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}