{"id":8756,"date":"2024-10-03T10:22:13","date_gmt":"2024-10-03T08:22:13","guid":{"rendered":"https:\/\/www.entecerma.it\/ecm-issues-its-first-mdr-certificate-under-article-22\/"},"modified":"2024-10-03T10:40:59","modified_gmt":"2024-10-03T08:40:59","slug":"ecm-issues-its-first-mdr-certificate-under-article-22","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/ecm-issues-its-first-mdr-certificate-under-article-22\/","title":{"rendered":"ECM issues its first MDR Certificate under Article 22"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\"><strong><em>ECM Medical Devices Division reaches an important milestone in the compliance of systems and procedure packs with the first certificate issued under Article 22 of the MDR.<\/em><\/strong><\/h2>\n\n<p>We are proud to announce that <strong>ECM Notified Body 128<\/strong>2 has recently issued its <strong>first certificate under Article 22 of Regulation MDR 2017\/745<\/strong>, related to <strong>systems and procedure packs<\/strong>. This achievement marks a significant step forward in our commitment to ensuring the compliance of medical devices according to the highest safety and quality standards.<\/p>\n\n<div style=\"height:26px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h3 class=\"wp-block-heading has-text-color has-link-color wp-elements-cf2e6bf18ac4fe387cd3209ae8226236\" style=\"color:#085f9b\"><strong>MDR ARTICLE 22 \u2013 SYSTEMS AND PROCEDURE PACKS<\/strong><\/h3>\n\n<p><strong>Article 22<\/strong> of the <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=celex%3A32017R0745\" target=\"_blank\" rel=\"noopener\"><strong>MDR Regulation<\/strong><\/a> establishes the specific requirements and procedures for combining CE-marked medical devices with other devices or products, in a manner that is compatible with their intended purpose and within the limits of use specified by manufacturers, to place them on the market as a <strong>system or procedure pack<\/strong>. The goal is to ensure that these devices, once assembled as system or procedure pack, maintain mutual compatibility and safety in use. This includes, among other aspects, the <strong>verification of sterilization<\/strong> according to the manufacturer&#8217;s instructions.<\/p>\n\n<div style=\"height:26px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h3 class=\"wp-block-heading has-text-color has-link-color wp-elements-bc695af1ccdf0bcd748dc7d3a9264d93\" style=\"color:#085f9b\"><strong>THE ECM&#8217;S ROLE IN ASSESSING SAFETY AND COMPLIANCE<\/strong><\/h3>\n\n<p>As <a href=\"https:\/\/www.entecerma.it\/en\/activities\/certifications\/product-and-service\/medical-devices-regulation-eu-2017-745\/\" target=\"_blank\" rel=\"noopener\"><strong>Notified Body No. 1282<\/strong><\/a>, we worked to verify that system or procedure pack\u00a0met the requirements set out in the MDR regulation. Our team ensured that <strong>sterilization<\/strong> was carried out correctly in compliance with the relevant standards and issued the <strong>EU Certificate<\/strong> under Regulation 2017\/745.<\/p>\n\n<p>The issuance of this first certificate under Article 22 is another step in our ongoing work in <strong>MDR certification<\/strong>, where we continue to issue certificates. Our commitment is to ensure that every device certified by ECM meets regulatory requirements, providing <strong>safety and reliabilit<\/strong>y to end users. With our expertise and competence, we are the ideal partner for manufacturers looking to start the conformity assessment process in compliance with the new EU regulations.<\/p>\n\n<p><strong>If you would like more information<\/strong> on the devices we can certify, take a look <a href=\"https:\/\/webgate.ec.europa.eu\/single-market-compliance-space\/notified-bodies\/notifications\/319592?organizationVersion=7\" target=\"_blank\" rel=\"noopener\">here<\/a>.<\/p>\n\n<p>You can contact us anytime to learn more about our MDR certification activities! Send an email to our Sales Department:&#13;\nDiego Stevanella <a href=\"mailto:diego.s@entecerma.it\" target=\"_blank\" rel=\"noreferrer noopener\">diego.s@entecerma.it<\/a> &#8211; Marzia Pellegrini <a href=\"mailto:marzia.p@entecerma.it\" target=\"_blank\" rel=\"noreferrer noopener\">marzia.p@entecerma.it<\/a><\/p>\n\n<p><strong><em>Are you interested in starting the certification process but unsure where to begin?<\/em><\/strong>&#13;\nCheck out our <a href=\"https:\/\/www.entecerma.it\/wp-content\/uploads\/2024\/10\/Infographic_Structured-Dialogue-service_ECM.pdf\" target=\"_blank\" rel=\"noopener\">Structured Dialogue<\/a> service and contact us for more information!<\/p>\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>ECM Medical Devices Division reaches an important milestone in the compliance of systems and procedure&#8230;<\/p>\n","protected":false},"author":2,"featured_media":8754,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2],"tags":[942,282,944,1472,913,128,1471,1166,569,123,1470,888,1473,180,1474],"class_list":["post-8756","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-certificazione-dispositivi-medici-en","tag-dispositivi-medici-en","tag-eu-certificate-en","tag-kit-procedurali-en","tag-mdr-en","tag-mdr-2017-745-en","tag-mdr-art-22-en","tag-mdr-notified-body-en","tag-medical-device-certification-en","tag-medical-devices-en","tag-medical-devices-re-en","tag-notified-body-1282-en","tag-procedure-packs-en","tag-regulatory-affairs-en","tag-sterilization-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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