{"id":6118,"date":"2022-11-11T11:40:11","date_gmt":"2022-11-11T10:40:11","guid":{"rendered":"https:\/\/www.entecerma.it\/activities\/certifications\/product-and-service\/medical-devices-regulation-eu-2017-745\/"},"modified":"2026-03-09T11:27:20","modified_gmt":"2026-03-09T10:27:20","slug":"medical-devices-regulation-eu-2017-745","status":"publish","type":"page","link":"https:\/\/www.entecerma.it\/en\/activities\/certifications\/product-and-service\/medical-devices-regulation-eu-2017-745\/","title":{"rendered":"Medical Devices Regulation (EU) 2017\/745"},"content":{"rendered":"\n<p><strong>Ente Certificazione Macchine <\/strong>is <strong><mark class=\"has-inline-color\" style=\"background-color: rgba(0, 0, 0, 0); color: #085a9d;\">Notified Body No. 1282 <\/mark><\/strong>for the European Medical Devices Regulation 2017\/745 (MDR), designated by the Italian Ministry of Health, with publication of the notification on the European Commission&#8217;s NANDO portal on 14 October 2022.<\/p>\n\n<p><strong><em>The list of accreditations and devices falling within the scope of ECM can be consulted on the European Commission&#8217;s <\/em><\/strong><a href=\"https:\/\/ec.europa.eu\/growth\/tools-databases\/nando\/index.cfm?fuseaction=notifiedbody.notifiedbody&amp;refe_cd=EPOS%5F50158\" target=\"_blank\" rel=\"noopener\"><strong><em>Nando Information System<\/em><\/strong><\/a><strong><em>.<\/em><\/strong><\/p>\n\n<p>View the <a href=\"https:\/\/www.entecerma.it\/wp-content\/uploads\/2024\/12\/All.1-Tariffario-Certificazioni-MDR_rev.06_copia-pubblica.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">ECM price list of conformity activities under MDR<\/a>.<\/p>\n\n<p>See the <a href=\"https:\/\/www.entecerma.it\/wp-content\/uploads\/2025\/04\/RG_MDR-Regolamento-di-certificazione-MDR-rev05.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Regulations for Medical Device Certification (MDR)<\/a>.<\/p>\n\n<div style=\"height:16px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"wp-block-heading has-text-align-center has-white-color has-text-color has-background\" style=\"background-color:#085f9b\"><strong>THE REGULATION (EU) 2017\/745<\/strong><\/h2>\n\n<p><strong><mark class=\"has-inline-color\" style=\"background-color: rgba(0, 0, 0, 0); color: #085a9d;\">Regulation (EU) 2017\/745 (MDR)<\/mark><\/strong>, which replaces Directives 93\/42\/EEC (MDD) and 90\/385\/EEC (AIMD), entered into force on 25 May 2017. After a transition period, <strong>as of<\/strong> <strong>26 May 2021<\/strong> the MDR applies to all manufacturers wishing to place their medical devices on the EU market.<\/p>\n\n<p>As of<strong> 27 May 2024<\/strong>, the MDR will be fully applicable to all medical devices, which can only be placed on the market with a valid EU certificate issued under the MDR.<\/p>\n\n<p>Regulation (EU) 2017\/745 imposes <strong>stringent compliance requirements<\/strong> aimed to ensure high standards of quality and safety and includes some significant differences from previous directives, including:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Extension of scope and\u00a0<strong>new classification criteria<\/strong>\u00a0(to also include devices that do not have an intended medical purpose);<\/li>\n\n\n\n<li>Definition of economic operators and related\u00a0<strong>duties<\/strong>;<\/li>\n\n\n\n<li>The manufacturer must establish a Person Responsible for Compliance (<strong>PRRC<\/strong>);<\/li>\n\n\n\n<li>New rules on traceability (<strong>UDI<\/strong>) and registration of medical devices (<strong>Eudamed<\/strong>);<\/li>\n\n\n\n<li>Stricter and more precise requirements regarding<strong>\u00a0technical documentation<\/strong>\u00a0and\u00a0<strong>clinical\u00a0<\/strong>evaluations and investigations;<\/li>\n\n\n\n<li>Increased post-market surveillance and\u00a0<strong>follow-up<\/strong>\u00a0obligations.<\/li>\n<\/ul>\n\n<div style=\"height:16px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"wp-block-heading has-text-align-center has-white-color has-text-color has-background\" style=\"background-color:#085f9b\"><strong>CLASSIFICATION AND CONFORMITY ASSESSMENT PROCEDURE<\/strong><\/h2>\n\n<p>Medical devices are divided into <strong>4 classes<\/strong> depending on their intended use and the risk they involve:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Class I devices (low\/medium risk), including Is \u2013 sterile, Im \u2013 measuring, IR \u2013 reusable;<\/li>\n\n\n\n<li>Class IIa devices (medium risk)<\/li>\n\n\n\n<li>Class IIb devices (medium\/high risk)<\/li>\n\n\n\n<li>Class III devices (high risk).<\/li>\n<\/ul>\n\n<p>Classification is carried out by the Manufacturer according to the criteria of Annex VIII of the MDR.<\/p>\n\n<p>Class I devices, excluding Is, Im and IR, do not require the intervention of the Notified Body and can be self-certified by the manufacturer. For all other risk classes (Is, Im, IR, IIa, IIb and III), the intervention of the Notified Body is required. <\/p>\n\n<p>The procedure for obtaining the <strong>EU Certificate<\/strong> differs depending on the <strong>risk class<\/strong> of the device.<\/p>\n\n<div style=\"height:16px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"wp-block-heading has-text-align-center has-white-color has-text-color has-background\" style=\"background-color:#085f9b\"><strong>THE ECM SERVICES<\/strong><\/h2>\n\n<p><strong>ECM Medical Devices Division<\/strong> is a team of experts in testing, regulatory assessment and quality auditing, able to provide certification services according to the MDR Regulation.<\/p>\n\n<p>Operating as <strong>Notified Body No. 1282<\/strong>, Ente Certificazione Macchine provides medical device manufacturers with a <strong>conformity assessment service for EU certification<\/strong> according to <strong>Regulation (EU) 2017\/745<\/strong>.<br\/><br\/>The <strong><mark class=\"has-inline-color\" style=\"background-color: rgba(0, 0, 0, 0); color: #085a9d;\">EU Certification process<\/mark><\/strong>\u00a0consists of several steps:<\/p>\n\n<ol class=\"wp-block-list\">\n<li><strong>Review<\/strong>\u00a0of technical\u00a0<strong>documentation<\/strong>\u00a0(including clinical evaluation) and Management System documentation;<\/li>\n\n\n\n<li><strong>Onsite Audit<\/strong>\u00a0to verify the Management System processes;<\/li>\n\n\n\n<li><strong>Final review<\/strong>\u00a0of all the evidence collected for the verification of the requirements of the Regulation;<\/li>\n\n\n\n<li><strong>Issue of the EU Certificate<\/strong>.<\/li>\n<\/ol>\n\n<p>ECM also carries out<strong> Structured Dialogue<\/strong> activities with the manufacturer, a formalized exchange that promotes transparency, clarity, and efficiency throughout the entire conformity assessment process.<\/p>\n\n<p>In addition, ECM provides the medical device market with the following services:<\/p>\n\n<ul class=\"wp-block-list\">\n<li><strong>Quality Management System Audit and Certification<\/strong>\u00a0according to the\u00a0<strong>ISO 13485<\/strong>\u00a0standard;<\/li>\n\n\n\n<li><strong>Testing services<\/strong>\u00a0as an ISO 17025 accredited Testing Laboratory.<\/li>\n<\/ul>\n\n<div style=\"height:14px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"wp-block-heading has-text-align-center has-white-color has-text-color has-background\" style=\"background-color:#085f9b\"><strong>REQUEST AN OFFER<\/strong><\/h2>\n\n<p>To request a quotation, you can download and fill out the form <a href=\"https:\/\/www.entecerma.it\/wp-content\/uploads\/2026\/03\/MDR_07_M00-Raccolta-dati-preliminari-MD-rev.10.docx\">Preliminary Data collection for medical device certification \u2013 MDR 2017\/745<\/a>\u00a0and see the document\u00a0<a href=\"https:\/\/www.entecerma.it\/wp-content\/uploads\/2024\/09\/MDR_07_All.to-1-Descrizione-e-presentazione-della-domanda-di-certificazione-rev.2_ITA_ENG.pdf\" target=\"_blank\" rel=\"noopener\">Description and submission of the medical device certification application \u2013 MDR 2017\/745<\/a>.<\/p>\n\n<p>To submit the completed<em>&#8220;Preliminary Data collection form for medical device certification \u2013 MDR 2017\/745&#8221;<\/em> and to request any information about our services for the medical device sector, you can contact our offices at <a href=\"mailto:info@entecerma.it\">info@entecerma.it<\/a> or reach out to our Sales Division: Diego Stevanella &#8211; <a href=\"mailto:diego.s@entecerma.it\">diego.s@entecerma.it<\/a> and Marzia Pellegrini &#8211; <a href=\"mailto:marzia.p@entecerma.it\">marzia.p@entecerma.it<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Ente Certificazione Macchine is Notified Body No. 1282 for the European Medical Devices Regulation 2017\/745&#8230;<\/p>\n","protected":false},"author":2,"featured_media":5258,"parent":565,"menu_order":48,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-6118","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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