{"id":29607,"date":"2021-04-19T15:42:24","date_gmt":"2021-04-19T13:42:24","guid":{"rendered":"http:\/\/website.creativephs.com\/?p=29607"},"modified":"2023-02-01T23:53:18","modified_gmt":"2023-02-01T21:53:18","slug":"the-new-medical-device-regulation","status":"publish","type":"post","link":"https:\/\/www.creativephs.com\/el\/2021\/04\/19\/the-new-medical-device-regulation\/","title":{"rendered":"The New Medical Device Regulation (MDR)"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row][vc_column]<div class=\"clearboth\"><\/div><style>#thegem-divider-69eff38a40526 {margin-top: -40px !important;}<\/style><div id=\"thegem-divider-69eff38a40526\" class=\"gem-divider  \" style=\"\" ><\/div>[\/vc_column][\/vc_row][vc_row][vc_column]<div class=\"clearboth\"><\/div><style>#thegem-divider-69eff38a4054c {margin-top: -40px !important;}<\/style><div id=\"thegem-divider-69eff38a4054c\" class=\"gem-divider  \" style=\"\" ><\/div>[vc_column_text]<\/p>\n<p style=\"text-align: justify;\"><a href=\"http:\/\/website.creativephs.com\/wp-content\/uploads\/2021\/04\/Medical-Devices-Newsletter.png\" target=\"_blank\" rel=\"noopener\"><img class=\"wp-image-29612 alignleft\" src=\"http:\/\/website.creativephs.com\/wp-content\/uploads\/2021\/04\/Medical-Devices-Newsletter-300x212.png\" alt=\"The new medical device regulation\" width=\"429\" height=\"303\" srcset=\"https:\/\/www.creativephs.com\/wp-content\/uploads\/2021\/04\/Medical-Devices-Newsletter-300x212.png 300w, https:\/\/www.creativephs.com\/wp-content\/uploads\/2021\/04\/Medical-Devices-Newsletter-1024x724.png 1024w, https:\/\/www.creativephs.com\/wp-content\/uploads\/2021\/04\/Medical-Devices-Newsletter-768x543.png 768w, https:\/\/www.creativephs.com\/wp-content\/uploads\/2021\/04\/Medical-Devices-Newsletter-1536x1086.png 1536w, https:\/\/www.creativephs.com\/wp-content\/uploads\/2021\/04\/Medical-Devices-Newsletter-2048x1448.png 2048w\" sizes=\"(max-width: 429px) 100vw, 429px\" \/><\/a><\/p>\n<p><strong>A Changing Landscape<\/strong><\/p>\n<p style=\"text-align: justify;\">Medical Device (MD) manufacturers are confronted with major changes in the EU\u2019s decades-old relevant regulatory framework. The Medical Device Regulation (MDR) entered into force on <strong>May 25th 2017<\/strong> will progressively replace the EU&#8217;s current Medical Devices Directive (93\/42\/EEC) and Active Implantable Medical Devices Directive (90\/385\/EEC) until <strong>May 26th 2021<\/strong> and <strong>May 2022<\/strong> respectively.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p style=\"text-align: justify;\"><strong>Get Ready for the New MDR<\/strong><\/p>\n<p style=\"text-align: justify;\"><em>ASK YOURSELF<\/em><\/p>\n<ul>\n<li>Are you fully aware and <strong>understand<\/strong> up- coming <strong>changes<\/strong>?<\/li>\n<li>Are you <strong>prepared to respond<\/strong> to the new requirements posed by the new MDR?<\/li>\n<li>What is the <strong>best approach<\/strong> for your <strong>product<\/strong> to be placed in the <strong>market<\/strong> under the new MDR?<\/li>\n<li>Are you clear on the little <strong>classification details<\/strong> that may have a big <strong>impact<\/strong> to your business ensuring continued <strong>marketability<\/strong>?<\/li>\n<li>New reporting <strong>EUDAMED<\/strong> requirements; Have you assigned the MD <strong>\u201cQualified Person\u201d<\/strong>?<\/li>\n<li>Are your unique MD <strong>identification and labelling procedures<\/strong> aligned with the new provisions?<\/li>\n<li>Are you ready to comply with the new <strong>technical documentation<\/strong> requirements?<\/li>\n<li>Have you considered assessing your current <strong>clinical evaluation adequacy<\/strong> for compliance with the new MDR?<\/li>\n<li>Have you evaluated the <strong>additional clinical data<\/strong> you may require for complying with the new MDR?<\/li>\n<li>Is your post <strong>marketing surveillance activities<\/strong> and <strong>PMS Plan<\/strong> adequately prepared as per the new MDR standards?<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>The deadline is approaching. Remember: All Medical Devices affected; old and new.<\/strong>[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Medical Device (MD) manufacturers are confronted with major changes in the EU\u2019s decades-old relevant regulatory framework. The Medical Device Regulation (MDR) entered into force on <strong>May 25th 2017<\/strong> will progressively replace the EU&#8217;s current Medical Devices Directive (93\/42\/EEC) and Active Implantable Medical Devices Directive (90\/385\/EEC) until May 26th 2021 and May 2022 respectively.<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_uf_show_specific_survey":0,"_uf_disable_surveys":false,"footnotes":""},"categories":[125],"tags":[],"class_list":{"0":"post-29607","1":"post","2":"type-post","3":"status-publish","4":"format-standard","6":"category-articles-el"},"aioseo_notices":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>The New Medical Device Regulation (MDR) - Creative Pharma &amp; HR Services<\/title>\n<meta name=\"robots\" content=\"noindex, follow\" \/>\n<meta property=\"og:locale\" content=\"el_GR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The New Medical Device Regulation (MDR) - Creative Pharma &amp; HR Services\" \/>\n<meta property=\"og:description\" content=\"Medical Device (MD) manufacturers are confronted with major changes in the EU\u2019s decades-old relevant regulatory framework. The Medical Device Regulation (MDR) entered into force on May 25th 2017 will progressively replace the EU&#039;s current Medical Devices Directive (93\/42\/EEC) and Active Implantable Medical Devices Directive (90\/385\/EEC) until May 26th 2021 and May 2022 respectively.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.creativephs.com\/el\/2021\/04\/19\/the-new-medical-device-regulation\/\" \/>\n<meta property=\"og:site_name\" content=\"Creative Pharma &amp; HR Services\" \/>\n<meta property=\"article:published_time\" content=\"2021-04-19T13:42:24+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-02-01T21:53:18+00:00\" \/>\n<meta property=\"og:image\" content=\"http:\/\/website.creativephs.com\/wp-content\/uploads\/2021\/04\/Medical-Devices-Newsletter-300x212.png\" \/>\n<meta name=\"author\" content=\"gtsakonas\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u03a3\u03c5\u03bd\u03c4\u03ac\u03c7\u03b8\u03b7\u03ba\u03b5 \u03b1\u03c0\u03cc\" \/>\n\t<meta name=\"twitter:data1\" content=\"gtsakonas\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u0395\u03ba\u03c4\u03b9\u03bc\u03ce\u03bc\u03b5\u03bd\u03bf\u03c2 \u03c7\u03c1\u03cc\u03bd\u03bf\u03c2 \u03b1\u03bd\u03ac\u03b3\u03bd\u03c9\u03c3\u03b7\u03c2\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 \u03bb\u03b5\u03c0\u03c4\u03ac\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.creativephs.com\/el\/2021\/04\/19\/the-new-medical-device-regulation\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.creativephs.com\/el\/2021\/04\/19\/the-new-medical-device-regulation\/\"},\"author\":{\"name\":\"gtsakonas\",\"@id\":\"https:\/\/www.creativephs.com\/el\/#\/schema\/person\/dcf47e316030bb89ec6c35889685f88f\"},\"headline\":\"The New Medical Device Regulation (MDR)\",\"datePublished\":\"2021-04-19T13:42:24+00:00\",\"dateModified\":\"2023-02-01T21:53:18+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.creativephs.com\/el\/2021\/04\/19\/the-new-medical-device-regulation\/\"},\"wordCount\":259,\"publisher\":{\"@id\":\"https:\/\/www.creativephs.com\/el\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.creativephs.com\/el\/2021\/04\/19\/the-new-medical-device-regulation\/#primaryimage\"},\"thumbnailUrl\":\"http:\/\/website.creativephs.com\/wp-content\/uploads\/2021\/04\/Medical-Devices-Newsletter-300x212.png\",\"articleSection\":[\"\u0386\u03c1\u03b8\u03c1\u03b1\"],\"inLanguage\":\"el\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.creativephs.com\/el\/2021\/04\/19\/the-new-medical-device-regulation\/\",\"url\":\"https:\/\/www.creativephs.com\/el\/2021\/04\/19\/the-new-medical-device-regulation\/\",\"name\":\"The New Medical Device Regulation (MDR) - Creative Pharma &amp; 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