{"id":127858,"date":"2025-07-04T13:26:44","date_gmt":"2025-07-04T11:26:44","guid":{"rendered":"https:\/\/lightweb.dev\/s\/key2compliance\/?post_type=product&#038;p=127858"},"modified":"2026-04-14T15:28:45","modified_gmt":"2026-04-14T13:28:45","slug":"introduction-to-ivdr-fundamentals-of-ivdr-and-ivd-ce-marking","status":"publish","type":"product","link":"https:\/\/lightweb.dev\/s\/key2compliance\/product\/introduction-to-ivdr-fundamentals-of-ivdr-and-ivd-ce-marking\/","title":{"rendered":"Introduction to IVDR &#8211; Fundamentals of IVDR and CE-marking of IVDs &#8211; Course"},"content":{"rendered":"<hr \/>\n<p>This is Part 1 of 3 in our IVDR training series \u201cMastering IVDR Compliance: From Fundamentals to Post-Market\u00a0Excellence\u201d.<br \/>\n(Click the titles below for information)<\/p>\n<ol>\n<li><a href=\"https:\/\/lightweb.dev\/s\/key2compliance\/product\/introduction-to-ivdr-fundamentals-of-ivdr-and-ivd-ce-marking\/\" rel=\"\">Introduction to IVDR &#8211; Fundamentals of IVDR and CE-marking of IVDs<\/a><\/li>\n<li><a href=\"https:\/\/lightweb.dev\/s\/key2compliance\/product\/ce-marking-risk-classification-of-ivds-technical-documentation\/\" rel=\"\">CE-marking \u2013 Risk classification of IVDs &amp; Technical Documentation<\/a><\/li>\n<li><a href=\"https:\/\/lightweb.dev\/s\/key2compliance\/product\/ivdr-performance-evaluation-risk-management-post-market-surveillance-and-pmpf\/\" rel=\"\">IVDR Performance Evaluation, Risk Management, incl Post-Market Surveillance and PMPF<\/a><\/li>\n<\/ol>\n<p>Special Bundle price for all 3 parts: 1250 Euro\u00a0 \u00a0<strong><a href=\"https:\/\/lightweb.dev\/s\/key2compliance\/product\/ivdr-training-series\/\">Order the bundle here \u2192<\/a><\/strong><br \/>\nNote. All parts are stand-alone, and you can attend one or more of them.<\/p>\n<hr \/>\n<p>The new EU regulation on In Vitro Diagnostic Regulation (IVDR 2017\/746) is reshaping the entire IVD industry with stricter requirements, risk-based classification and enhanced post-market obligations. Demonstrating compliance for CE-marking of IVD devices has become more rigorous and there is no room for shortcuts.<\/p>\n<p>If you are in the IVD industry, this training series is your gateway to understanding the IVDR and the CE-marking process.<\/p>\n<p>Take the opportunity to gain clarity and confidence, IVDR isn\u2019t optional\u2014 it\u2019s mission-critical.<\/p>\n<h3>Course description<\/h3>\n<p>This\u00a0course\u00a0is the first\u00a0of three\u00a0modules\u00a0in our new IVDR training series\u00a0\u201cMastering IVDR Compliance: From Fundamentals to Post-Market Excellence\u201d.<\/p>\n<p>This first course provides a comprehensive introduction to IVDR giving you an overall understanding of the fundamentals, requirements, and practical implications for CE-marking of IVDs.<\/p>\n<p>You will learn the scope, structure, and key principles of IVDR to understand its impact on new and existing IVD\u00b4s. Through interactive lecture sessions, real-world examples, and expert guidance, you will gain knowledge and practical insights into the implementation of IVDR and requirements for the CE-marking.<\/p>\n<p>Whether you\u2019re new to IVDR or seeking a solid refresher, you\u2019ll gain valuable knowledge and insights to navigate the regulation in your daily work.<\/p>\n<h3>Learning Outcomes\/Benefits<\/h3>\n<ul>\n<li>Increase your understanding of IVDR and principles for CE-marking of IVDs<\/li>\n<li>Gain skills in qualification IVD\u00b4s to understand the difference from accessories, RUO, Lab equipment and test methods<\/li>\n<li>Increase your understanding of the new risk classification and how to apply the classification rules<\/li>\n<li>Interpret and apply the General Safety and Performance Requirements (Annex I)<\/li>\n<li>Describe the principles of a quality management system and how ISO 13485 supports in compliance with IVDR<\/li>\n<li>Describe the principles of conformity assessment and get some best practice<\/li>\n<\/ul>\n<h3>Course Content<\/h3>\n<ul>\n<li>Key elements of IVDR and main changes from IVDD<\/li>\n<li>CE-marking road map<\/li>\n<li>IVDs, accessories, methods, laboratory equipment or RUO \u2013 what is what?<\/li>\n<li>New approach for risk classification of IVD\u00b4s<\/li>\n<li>General Safety and Performance Requirements &#8211; The backbone of IVDR<\/li>\n<li>Quality management and alignment with ISO 13485<\/li>\n<li>Overview of Technical Documentation<\/li>\n<li>Conformity assessment and Notified Body scrutiny<\/li>\n<\/ul>\n<h3>Target Audience<\/h3>\n<p>This course is ideal for professionals\u00a0within the IVD industry\u00a0and\u00a0IVD related research\u00a0such as:<\/p>\n<ul>\n<li>Regulatory Affairs managers\/specialists<\/li>\n<li>Quality Assurance managers\/ specialists<\/li>\n<li>Clinical\/Medical Affairs managers<\/li>\n<li>Development managers\/engineers<\/li>\n<li>Production managers\/staff<\/li>\n<\/ul>\n<h3>Prerequisites<\/h3>\n<p>No prior expert knowledge of the IVDR is\u00a0required, but a basic understanding of\u00a0development or production of\u00a0IVD\u00b4s, medical devices\u00a0or\u00a0other products in a\u00a0regulatory\u00a0controlled industry\u00a0will help participants get the most out of the course.<\/p>\n<p>Examples of such experience are,<\/p>\n<ul>\n<li>Basic understanding of IVDR, IVDD, MDR or MDD<\/li>\n<li>Basic understanding of quality management e.g. ISO 13485, GMP, GLP<\/li>\n<li>Experience from IVD, medical device or pharma industry e.g development or production<\/li>\n<li>Experience of e.g. methods, tests, software, instruments for IVD or related research<\/li>\n<li>Experience from Clinical\/Medical affairs for IVD\u00b4s or medical devices<\/li>\n<\/ul>\n<h3>Duration<\/h3>\n<p>Half day (3,5 hours)<\/p>\n<p>&nbsp;<\/p>\n<p>#5331<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Learn about the IVDR and CE-marking of IVD medical devices. Understand the regulatory requirements for IVD medical devices. Understand the obligations under IVDR<\/p>\n","protected":false},"featured_media":127866,"template":"","meta":{"_acf_changed":false,"wds_primary_product_brand":0,"wds_primary_product_cat":0},"product_brand":[],"product_cat":[18],"product_tag":[267,300,327],"class_list":{"0":"post-127858","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-in-house","7":"product_tag-ivd","8":"product_tag-ivdr","9":"product_tag-regulatory-compliance","10":"pa_industry-ivd","11":"pa_industry-medical-device","12":"pa_language-english","13":"pa_level-intermediate","14":"pa_location-online","15":"pa_region-eu","17":"first","18":"instock","19":"virtual","20":"taxable","21":"purchasable","22":"product-type-simple"},"acf":[],"_links":{"self":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/product\/127858","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/media\/127866"}],"wp:attachment":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/media?parent=127858"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/product_brand?post=127858"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/product_cat?post=127858"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/product_tag?post=127858"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}