{"id":2171,"date":"2019-11-06T09:30:00","date_gmt":"2019-11-06T08:30:00","guid":{"rendered":"https:\/\/www.entecerma.it\/increased-attention-towards-the-new-mdr-the-26-may-2020-is-coming\/"},"modified":"2019-11-06T09:30:00","modified_gmt":"2019-11-06T08:30:00","slug":"increased-attention-towards-the-new-mdr-the-26-may-2020-is-coming","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/increased-attention-towards-the-new-mdr-the-26-may-2020-is-coming\/","title":{"rendered":"INCREASED ATTENTION TOWARDS THE NEW MDR, THE 26 MAY 2020 IS COMING"},"content":{"rendered":"<p>Last October, our Technical Manager <em>Eng. Vanessa Biavati<\/em>, and our Clinical Expert\u00a0<em>Dr.<\/em>\u00a0<em>Marianna Mastroroberto<\/em>, took part in the\u00a0<strong>MDR Clinical Data Training<\/strong>\u00a0organized by\u00a0<strong>Team NB<\/strong> &#8211; the association that brings together the major European Notified Bodies for medical devices.<\/p>\n<p>The meeting, focused on the new requirements of\u00a0<strong>Regulation (EU) 2017\/745<\/strong>\u00a0for\u00a0<strong>clinical evaluation<\/strong>, was a key moment of dialogue and discussion in order to achieve a better harmonization between the notified bodies involved in sharing the application of the new regulation.<\/p>\n<p>ECM is a member of the NB Team, a prestigious recognition that means to become part of an internationally recognized organization, where members work together to clarify and bring their opinion on the main regulatory issues.<\/p>\n<p><a href=\"http:\/\/www.team-nb.org\/\" target=\"_blank\" rel=\"noopener noreferrer\"><strong>Team NB<\/strong><\/a>\u00a0&#8211; the\u00a0<em>European Association of Notified Bodies for Medical Devices<\/em> &#8211; was founded in 2001 and currently has 26 members from 14 different countries, who cooperate with the purpose of promoting <strong>trasparency<\/strong> and <strong>communication<\/strong>\u00a0between Notified Bodies, to provide constant update and discussion at the regulatory level. The association aims to support the innovation and continuous development of the medical devices sector, through the guarantees of\u00a0<strong>quality<\/strong>,\u00a0<strong>safety<\/strong>\u00a0and\u00a0<strong>effectiveness<\/strong>\u00a0ensured by certification.<\/p>\n<p>Being part of Team NB means participating in moments of exchange fundamental for a better understanding of the regulatory landscape, dealing with interlocutors of high competence and experience. The regulatory changes that will be introduced by the new\u00a0<strong>MDR 2017\/745<\/strong>\u00a0require constant\u00a0<strong>updating<\/strong>, supported by open dialogue with institutions and other stakeholders.<\/p>\n<p>The certification of medical devices is an essential element for manufacturers to maintain high\u00a0<strong>confidence<\/strong>\u00a0in their products. Therefore, it is essential to choose a Notified Body that &#8211; in addition to the proven skills resulting from accreditation &#8211; is aware of the regulatory evolution, in order to ensure high standards of\u00a0<strong>reliability<\/strong>\u00a0and\u00a0<strong>safety<\/strong>.<\/p>\n<p>ECM is working with commitment and dedication on the necessary activities to obtain as soon as possible the accreditation as Notified Body for the MDR. Given the increasing knowledge it is acquiring, ECM invites manufacturers and medical devices professionals to prepare for the incoming changes by\u00a0<strong>contacting us<\/strong>: ECM Sales Manager\u00a0<strong>Antonio Balassone<\/strong>\u00a0&#8211;\u00a0<a href=\"mailto:antonio@entecerma.it\">antonio@entecerma.it<\/a>\u00a0| mob. +39 393 2471040<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Last October, our Technical Manager Eng. Vanessa Biavati, and our Clinical Expert\u00a0Dr.\u00a0Marianna Mastroroberto, took part&#8230;<\/p>\n","protected":false},"author":2,"featured_media":2169,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2],"tags":[128,123,127],"class_list":["post-2171","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-mdr-2017-745-en","tag-medical-devices-en","tag-regulation-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>INCREASED ATTENTION TOWARDS THE NEW MDR, THE 26 MAY 2020 IS COMING - Ente Certificazione Macchine<\/title>\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\/increased-attention-towards-the-new-mdr-the-26-may-2020-is-coming\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"INCREASED ATTENTION TOWARDS THE NEW MDR, THE 26 MAY 2020 IS COMING - Ente Certificazione Macchine\" \/>\n<meta property=\"og:description\" content=\"Last October, our Technical Manager Eng. 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