{"id":611,"date":"2023-04-25T16:10:32","date_gmt":"2023-04-25T14:10:32","guid":{"rendered":"https:\/\/ceiso.fr\/en\/?p=611"},"modified":"2023-06-16T16:07:30","modified_gmt":"2023-06-16T14:07:30","slug":"obligations-of-economic-operators","status":"publish","type":"post","link":"https:\/\/ceiso.fr\/en\/e-learning\/obligations-of-economic-operators\/","title":{"rendered":"E-MDR-MOD-02 &#8211; Obligations of Economic Operators"},"content":{"rendered":"\n<div class=\"wp-block-group info-intro-container is-layout-constrained\"><div class=\"wp-block-group__inner-container\">\n<p class=\"info-intro ref\">REF. E-MDR-MOD-02 \u2013 E-LEARNING<\/p>\n\n\n\n<p class=\"info-intro pole\">EUROPEAN REGULATIONS<\/p>\n\n\n\n<p class=\"info-intro reglement\"><strong>REGULATION (EU) 2017\/745<\/strong><\/p>\n<\/div><\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-group description-block is-layout-constrained\"><div class=\"wp-block-group__inner-container\">\n<h2 class=\"wp-block-heading\">COURSE DESCRIPTION<\/h2>\n\n\n\n<p>The Obligations of Economic Operators module presents the parties who are governed by Regulation (EU) 2017\/745 and the obligations incumbent on economic operators active on the Medical Device (MD) market.<\/p>\n<\/div><\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"formation-info-container\">\n\t<div class=\"formation-info-block\">\n\t\t<h3>DURATION<\/h3>\n\t\t<p>37 minutes, including a 25-minute lesson and 12 minutes of quizzes<\/p>\n\t<\/div>\n\t<div class=\"formation-info-block with-img\">\n\t\t<img decoding=\"async\" src=\"https:\/\/ceiso.fr\/en\/wp-content\/uploads\/sites\/2\/2023\/04\/CEISO-icone_Formation-E-Learning.png\">\n\t\t<h3>E-LEARNING<\/h3>\n\t<\/div>\n        <div class=\"formation-info-block\">\n\t\t<h3>TECHNICAL PREREQUISITES<\/h3>\n\t\t<p>Computer and internet connection<\/p>\n\t<\/div>\n<\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-group formation-block is-layout-constrained\"><div class=\"wp-block-group__inner-container\">\n<h2 class=\"wp-block-heading\">METHODS USED<\/h2>\n\n\n\n<p>The module is composed of a lesson in the form of an interactive video with voice-off and learning activities. The module can be accessed 24\/7. Reminders are sent to monitor knowledge acquisition and avoid a break in the learning curve.<\/p>\n<\/div><\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-group formation-block is-layout-constrained\"><div class=\"wp-block-group__inner-container\">\n<h2 class=\"wp-block-heading\">TARGET TRAINEES<\/h2>\n\n\n\n<p>All individuals involved in the MD sector<\/p>\n<\/div><\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-group formation-block is-layout-constrained\"><div class=\"wp-block-group__inner-container\">\n<h2 class=\"wp-block-heading\">PREREQUISITES<\/h2>\n\n\n\n<p>Knowledge of the Regulation\u2019s main definitions and general principles (N.B. covered in the Overview module)<\/p>\n<\/div><\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-group formation-block is-layout-constrained\"><div class=\"wp-block-group__inner-container\">\n<h2 class=\"wp-block-heading\">ACCESS<\/h2>\n\n\n\n<p>The CEISO ACADEMY platform can be accessed for a period of two months within two business days at most of approval of your order.<\/p>\n<\/div><\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-group formation-block is-layout-constrained\"><div class=\"wp-block-group__inner-container\">\n<h2 class=\"wp-block-heading\">ADDITIONAL BENEFITS<\/h2>\n\n\n\n<p>Summary presentation of the regulation<\/p>\n\n\n\n<p>Support materials designed by experienced consultants-trainers<\/p>\n\n\n\n<p>Interactive lesson<\/p>\n\n\n\n<p>Short modules that can be accessed as often as required and autonomously<br>As an option, you may select Q&amp;A sessions with one of our consultants-trainers<\/p>\n<\/div><\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-group formation-block is-layout-constrained\"><div class=\"wp-block-group__inner-container\">\n<h2 class=\"wp-block-heading\">EDUCATIONAL GOALS<\/h2>\n\n\n\n<ul>\n<li>Become familiar with the economic operators on the medical device market<\/li>\n\n\n\n<li>Identify the obligations incumbent on each of these operators<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-group formation-block grey is-layout-constrained\"><div class=\"wp-block-group__inner-container\">\n<h2 class=\"wp-block-heading\">COURSE CONTENT<\/h2>\n\n\n\n<p><strong>Assistance with navigation\/Module objectives\/Presentation of the course content<\/strong><\/p>\n\n\n\n<ol>\n<li>Parties involved<\/li>\n\n\n\n<li>Manufacturer\u2019s obligations<\/li>\n\n\n\n<li>Authorized representative\u2019s obligations<\/li>\n\n\n\n<li>Importer\u2019s obligations<\/li>\n\n\n\n<li>Distributor\u2019s obligations<\/li>\n<\/ol>\n<\/div><\/div>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-group formation-block is-layout-constrained\"><div class=\"wp-block-group__inner-container\">\n<h2 class=\"wp-block-heading\">EVALUATION METHODS<\/h2>\n\n\n\n<ul>\n<li>Course evaluation quiz<\/li>\n\n\n\n<li>Satisfaction survey<\/li>\n\n\n\n<li>Attendance certificate<\/li>\n<\/ul>\n\n\n\n<p><em>This training is assessed based on each individual\u2019s acquisition of knowledge via a quiz at the end of the program <em>(success criteria &gt;= 80%).<\/em> If trainees pass the quiz, they receive their training certificate, as well as the corrected quiz, by email.<\/em><\/p>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>REF. E-MDR-MOD-02 \u2013 E-LEARNING EUROPEAN REGULATIONS REGULATION (EU) 2017\/745 COURSE DESCRIPTION The Obligations of Economic Operators module presents the parties who are governed by Regulation (EU) 2017\/745 and the obligations incumbent on economic operators active on the Medical Device (MD) market. DURATION 37 minutes, including a 25-minute lesson and 12 minutes of quizzes E-LEARNING TECHNICAL [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[8,10],"tags":[],"_links":{"self":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/611"}],"collection":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/comments?post=611"}],"version-history":[{"count":3,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/611\/revisions"}],"predecessor-version":[{"id":731,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/posts\/611\/revisions\/731"}],"wp:attachment":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/media?parent=611"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/categories?post=611"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/tags?post=611"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}