{"id":4090,"date":"2021-05-05T12:03:03","date_gmt":"2021-05-05T10:03:03","guid":{"rendered":"https:\/\/www.entecerma.it\/mdr-2017-745-article-120-provisions-on-the-marketing-of-devices-and-validity-of-ec-certificates\/"},"modified":"2021-05-05T12:19:02","modified_gmt":"2021-05-05T10:19:02","slug":"mdr-2017-745-article-120-provisions-on-the-marketing-of-devices-and-validity-of-ec-certificates","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/mdr-2017-745-article-120-provisions-on-the-marketing-of-devices-and-validity-of-ec-certificates\/","title":{"rendered":"MDR 2017\/745 &#8211; Article 120: Provisions on the marketing of devices and validity of EC certificates"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\" style=\"font-size:25px\"><strong>Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017\/745 (MDR) states that devices which have a valid certificate issued by a Notified Body under the Medical Devices Directive 93\/42\/EEC (MDD) may be placed on the market or put into service after the date of application of the MDR,<em>\u00a0under certain conditions and no later than 26 May 2024.<\/em><\/strong><\/h2>\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p>These conditions imply the following:<\/p>\n\n<ul class=\"wp-block-list\"><li><strong>NO<\/strong> <strong>significant changes in the design and intended purpose<\/strong> of a device must be made after the date of application of the MDR \u2013 expected on 26 May 2021;<\/li><\/ul>\n\n<ul class=\"wp-block-list\"><li>in case of changes that are not significant with regard to design or intended purpose, <strong>the required surveillance or documental assessment MUST<\/strong> be carried out by the <strong>Notified Body that issued the certificate.<\/strong><\/li><\/ul>\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h4 class=\"wp-block-heading\" style=\"font-size:22px\"><strong><em><span class=\"has-inline-color\" style=\"color: #085f9b;\">WHAT MANUFACTURERS MUST DO<\/span><\/em><\/strong><\/h4>\n\n<p>Manufacturers must <strong>adjust their change notification procedures<\/strong>, in accordance with the principles outlined in MDR Art. 120. The adjusted procedures will be <strong>subject to notified body assessment <\/strong>within their surveillance activities according to MDR Art. 120(3).<\/p>\n\n<p style=\"font-size:21px\"><strong><u>It is important to highlight that no issuing of new MDD certificates, including modified, amended or supplemented certificates, is allowed under MDR Article 120(3).<\/u><\/strong><\/p>\n\n<p>If the manufacturer wishes to make a \u201c<em>significant change in design or intended purpose<\/em>\u201d under MDR Article 120(3), the implementation of such a change would prevent the manufacturer from continuing to place that device on the market under the Directives.<\/p>\n\n<p>In line with agreed arrangements for notification of changes between the manufacturer and the notified body according to the MDD (e.g. accepted regulation, approved procedures) <strong>changes and their implementation will be verified by the notified body<\/strong> as part of the surveillance activities, or following a manufacturer\u2019s submission for prior approval. The outcome of this verification will determine whether a certificate in accordance with MDD remains valid according to Article 120 MDR.<\/p>\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p class=\"has-background has-medium-font-size\" style=\"background-color:#e9e9e9\"><strong><span class=\"has-inline-color has-vivid-red-color\">ATTENTION!<\/span> Manufacturers are NOT allowed to make significant changes in design or in the intended purpose<\/strong>. Hence, <strong>all the changes must be communicated to the Notified Body before their implementation<\/strong>, that will determine whether the changes are significant.<\/p>\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<hr class=\"wp-block-separator is-style-wide\"\/>\n\n<p><strong>For more information<\/strong>, please contact our Sales Manager:<\/p>\n\n<p><em>Antonio Balassone<\/em> email <a href=\"mailto:antonio@entecerma.it\">antonio@entecerma.it<\/a>\u00a0| mob. (+39) 393 2471040<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017\/745 (MDR) states that devices&#8230;<\/p>\n","protected":false},"author":2,"featured_media":4081,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2],"tags":[406,517,282,128,404,123,185],"class_list":["post-4090","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-articolo-120-mdr-en","tag-destinazione-duso-en","tag-dispositivi-medici-en","tag-mdr-2017-745-en","tag-medical-device-regulation-en","tag-medical-devices-en","tag-organismo-notificato-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>MDR 2017\/745 - Article 120: Provisions on the marketing of devices and validity of EC certificates - Ente Certificazione Macchine<\/title>\n<meta name=\"description\" content=\"Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017\/745 (MDR) states that devices which have a valid certificate issued by a Notified Body under the Medical Devices Directive 93\/42\/EEC (MDD) may be placed on the market or put into service after the date of application of the MDR under certain conditions and no later than 26 May 2024.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.entecerma.it\/en\/mdr-2017-745-article-120-provisions-on-the-marketing-of-devices-and-validity-of-ec-certificates\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MDR 2017\/745 - Article 120: Provisions on the marketing of devices and validity of EC certificates - Ente Certificazione Macchine\" \/>\n<meta property=\"og:description\" content=\"Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017\/745 (MDR) states that devices which have a valid certificate issued by a Notified Body under the Medical Devices Directive 93\/42\/EEC (MDD) may be placed on the market or put into service after the date of application of the MDR under certain conditions and no later than 26 May 2024.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.entecerma.it\/en\/mdr-2017-745-article-120-provisions-on-the-marketing-of-devices-and-validity-of-ec-certificates\/\" \/>\n<meta property=\"og:site_name\" content=\"Ente Certificazione Macchine\" \/>\n<meta property=\"article:published_time\" content=\"2021-05-05T10:03:03+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-05-05T10:19:02+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.entecerma.it\/wp-content\/uploads\/2021\/05\/2021.05.05_MDR-2017745-Articolo-120-disposizioni-sulla-commercializzazione-dei-dispositivi-e-la-validita-dei-certificati-CE.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1600\" \/>\n\t<meta property=\"og:image:height\" content=\"900\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"entecerma\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"entecerma\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/mdr-2017-745-article-120-provisions-on-the-marketing-of-devices-and-validity-of-ec-certificates\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/mdr-2017-745-article-120-provisions-on-the-marketing-of-devices-and-validity-of-ec-certificates\\\/\"},\"author\":{\"name\":\"entecerma\",\"@id\":\"https:\\\/\\\/www.entecerma.it\\\/en\\\/#\\\/schema\\\/person\\\/b2c76707e5a5c46c1c3cf1e617980f5e\"},\"headline\":\"MDR 2017\\\/745 &#8211; 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