{"id":2096,"date":"2024-09-16T09:33:23","date_gmt":"2024-09-16T09:33:23","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=2096"},"modified":"2024-10-18T07:04:35","modified_gmt":"2024-10-18T07:04:35","slug":"%f0%9f%9a%a8-countdown-for-mdr-certification-imminent-deadline-for-legacy-devices","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/%f0%9f%9a%a8-countdown-for-mdr-certification-imminent-deadline-for-legacy-devices\/","title":{"rendered":"\ud83d\udea8 Countdown for MDR Certification: Imminent Deadline for Legacy Devices!"},"content":{"rendered":"

If your medical device is not yet fully compliant with the <\/span>Medical Devices Regulation (MDR)<\/b><\/span>, retaining \u00ablegacy device\u00bb status is crucial to continue placing your products on the EU market. <\/span>Article 120<\/b><\/span> of the <\/span>MDR <\/b><\/span>outlines key deadlines that must be met.<\/span><\/p>\n

\ud83d\udcc5 Upcoming Deadline<\/b>: 26 September 2024<\/p>\n

By 26 September 2024, you must have a written agreement with a notified body to obtain MDR CE certification<\/b> for your legacy devices. By 26 May 2024, you should have submitted an application to the notified body, which needs to be formalized with this written agreement.<\/p>\n

\ud83d\udd0d Key Requirements to Maintain Legacy Device Status<\/b>:<\/p>\n

    \n
  • MDR Application<\/b>: Submit by 26 May 2024.<\/li>\n
  • Quality Management System (QMS)<\/b>: Must be in place by 26 May 2024.<\/li>\n
  • Ongoing Compliance<\/b>: The device must comply with the applicable Directive and must not undergo significant changes in design or intended use.<\/li>\n
  • Safety and Surveillance<\/b>: The device must not present unacceptable risks and must comply with MDR requirements for post-market surveillance.<\/li>\n<\/ul>\n

    \ud83d\udd04 What to Expect After 26 September 2024<\/b>: Only the notified body for MDR certification<\/b> will be authorized to perform surveillance activities. The \u00aboutgoing\u00bb notified body will collaborate with the MDR<\/b> notified body to ensure a smooth transition of surveillance activities.<\/p>\n

    \ud83d\udcde Need assistance with these requirements?<\/b> Contact us for personalized support and ensure your devices are compliant and ready for the future.<\/p>\n

    #MedicalDevices #MDRCompliance #LegacyDevices #RegulatoryUpdates #Healthcare #MedicalDeviceRegulation #DeviceCertification #EURegulations<\/p>\n<\/div>

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    \n Rate this<\/span>\n <\/div>\n <\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"gallery","meta":{"_acf_changed":false,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-2096","post","type-post","status-publish","format-gallery","hentry","category-sin-categorizar","post_format-post-format-gallery"],"acf":[],"yoast_head":"\n\ud83d\udea8 Countdown for MDR Certification: Imminent Deadline for Legacy Devices! | CMC Medical Devices<\/title>\n<meta name=\"robots\" content=\"noindex, follow\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\ud83d\udea8 Countdown for MDR Certification: Imminent Deadline for Legacy Devices! | CMC Medical Devices\" \/>\n<meta property=\"og:url\" content=\"https:\/\/cmcmedicaldevices.com\/es\/\ud83d\udea8-countdown-for-mdr-certification-imminent-deadline-for-legacy-devices\/\" \/>\n<meta property=\"og:site_name\" content=\"CMC Medical Devices\" \/>\n<meta property=\"article:published_time\" content=\"2024-09-16T09:33:23+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-10-18T07:04:35+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2024\/06\/Logo-SEO-CMC.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"675\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"author\" content=\"Admin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Admin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/cmcmedicaldevices.com\/es\/%f0%9f%9a%a8-countdown-for-mdr-certification-imminent-deadline-for-legacy-devices\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/cmcmedicaldevices.com\/es\/%f0%9f%9a%a8-countdown-for-mdr-certification-imminent-deadline-for-legacy-devices\/\"},\"author\":{\"name\":\"Admin\",\"@id\":\"https:\/\/cmcmedicaldevices.com\/#\/schema\/person\/053251251c0ef9624cec28df99b802cf\"},\"headline\":\"\ud83d\udea8 Countdown for MDR Certification: Imminent Deadline for Legacy Devices!\",\"datePublished\":\"2024-09-16T09:33:23+00:00\",\"dateModified\":\"2024-10-18T07:04:35+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/cmcmedicaldevices.com\/es\/%f0%9f%9a%a8-countdown-for-mdr-certification-imminent-deadline-for-legacy-devices\/\"},\"wordCount\":874,\"publisher\":{\"@id\":\"https:\/\/cmcmedicaldevices.com\/#organization\"},\"articleSection\":[\"Sin categorizar\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/cmcmedicaldevices.com\/es\/%f0%9f%9a%a8-countdown-for-mdr-certification-imminent-deadline-for-legacy-devices\/\",\"url\":\"https:\/\/cmcmedicaldevices.com\/es\/%f0%9f%9a%a8-countdown-for-mdr-certification-imminent-deadline-for-legacy-devices\/\",\"name\":\"\ud83d\udea8 Countdown for MDR Certification: Imminent Deadline for Legacy Devices! 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