{"id":127859,"date":"2025-07-04T13:30:23","date_gmt":"2025-07-04T11:30:23","guid":{"rendered":"https:\/\/lightweb.dev\/s\/key2compliance\/?post_type=product&p=127859"},"modified":"2026-04-14T15:28:17","modified_gmt":"2026-04-14T13:28:17","slug":"ce-marking-risk-classification-of-ivds-technical-documentation","status":"publish","type":"product","link":"https:\/\/lightweb.dev\/s\/key2compliance\/product\/ce-marking-risk-classification-of-ivds-technical-documentation\/","title":{"rendered":"CE-marking \u2013 Risk classification of IVDs & Technical Documentation – Course"},"content":{"rendered":"
\n

This is Part 2 of 3 in our IVDR training series.\u00a0(Click the titles below for information)<\/p>\n

    \n
  1. Introduction to IVDR – Fundamentals of IVDR and CE-marking of IVDs<\/a><\/li>\n
  2. CE-marking \u2013 Risk classification of IVDs & Technical Documentation<\/a><\/li>\n
  3. IVDR Performance Evaluation, Risk Management, incl Post-Market Surveillance and PMPF<\/a><\/li>\n<\/ol>\n

    Special Bundle price for all 3 parts: 1250 Euro –\u00a0 Order the bundle here \u2192<\/a><\/strong>
    \nNote. All parts are stand-alone, and you can attend one or more of them.<\/p>\n

    \n

     <\/p>\n

    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\u00a0rigorous\u00a0and there is no room for shortcuts.<\/p>\n

    If you are in the IVD industry, this training series is your gateway to understanding the IVDR and the CE-marking process.<\/p>\n

    Take the opportunity to gain clarity and confidence, IVDR isn\u2019t optional\u2014 it\u2019s mission-critical.<\/p>\n

    Course description<\/h3>\n

    This\u00a0course\u00a0is the\u00a0second\u00a0of three\u00a0modules\u00a0in our new IVDR training series\u00a0\u201cMastering IVDR Compliance: From Fundamentals to Post-Market Excellence\u201d.\u00a0The course is taking a deeper dive into IVDR\u00a0exploring\u00a0the\u00a0risk classification\u00a0and its implications,\u00a0the\u00a0general safety and performance requirements\u00a0in Annex\u00a0I and\u00a0the\u00a0creation of\u00a0Technical\u00a0Documentation.<\/p>\n

    The risk classification and the Technical Documentation are essential parts of IVDR and fundamentals for CE-marking.\u00a0\u00a0This course explains the shift to the new rule-based risk classification of IVDs and its practical implications. You will gain a clear understanding of the importance of the intended purpose and how to apply the classification rules to determine appropriate risk class. Following the risk classification, the course focuses on exploring the general safety and performance requirements\u00a0 – the backbone of IVDR, and how to create the Technical Documentation to demonstrate compliance with the requirements. Details on the structure and content of the Technical Documentation will be further explained and how to maintain the documentation during the entire lifetime of the product.<\/p>\n

    Whether you need to learn the details or seek a solid refresher, you\u2019ll gain valuable knowledge to understand the details of the risk classification and the Technical Documentation.<\/p>\n

    Learning Outcomes\/Benefits<\/h3>\n
      \n
    • Understand the details of the new\u00a0rule-based\u00a0risk classification\u00a0and how to apply the rules on\u00a0different types\u00a0of IVDs<\/li>\n
    • Gain skills in risk classification and determine risk class of your products<\/li>\n
    • Identify applicable General Safety and Performance Requirements and to how demonstrate compliance<\/li>\n
    • Design of labels and instructions for use<\/li>\n
    • Know the content and structure to create the Technical Documentation<\/li>\n<\/ul>\n

      Course Content<\/h3>\n
        \n
      • Crafting a well-defined Intended purpose<\/li>\n
      • The new rule-based risk classification and its implications<\/li>\n
      • How to apply the classification rules determine the risk classification<\/li>\n
      • General Safety and Performance Requirements and how to demonstrate compliance<\/li>\n
      • Product information (IFU, labelling)<\/li>\n
      • Tell the story – Structure and content of Technical Documentation<\/li>\n
      • Creation and maintenance of Technical Documentation<\/li>\n<\/ul>\n

        Target Audience<\/h3>\n

        This course is ideal for professionals\u00a0within the IVD industry\u00a0and\u00a0IVD related research\u00a0such as:<\/p>\n

          \n
        • Regulatory Affairs managers\/specialists<\/li>\n
        • Quality Assurance managers\/ specialists<\/li>\n
        • Technical managers<\/li>\n
        • Development managers\/engineers<\/li>\n<\/ul>\n

          Prerequisites<\/h3>\n

          Course Module 1: “Introduction to IVDR \u2013 Fundamentals of IVDR and CE-marking of IVDs” is strongly recommended since this course is the second part of the IVDR training series \u201cMastering IVDR Compliance: From Fundamentals to Post-Market Excellence\u201d<\/p>\n

          and\/or,<\/p>\n

          Knowledge of IVDR fundamentals and development of IVDs gathered through other IVDR training and\/or experience.<\/p>\n

          Examples of such experience are:<\/p>\n

            \n
          • Experience from IVDR, IVDD<\/li>\n
          • Experience from development of IVD\u00b4s , medical device or related research products<\/li>\n
          • Experience of e.g. methods, tests, software, instruments for IVD or related research.<\/li>\n<\/ul>\n

             <\/p>\n

            #5332<\/p>\n","protected":false},"excerpt":{"rendered":"

            Learn about the new rule-based risk classification. Understand how the risk classification impacts on the conformity assessment route
            \nLearn about the general safety and performance requirements and how to demonstrate compliance
            \nUnderstand the structure and content of the Technical Documentation
            \nUnderstand how design changes to the product design impact on the technical documentation<\/p>\n","protected":false},"featured_media":127867,"template":"","meta":{"_acf_changed":false,"wds_primary_product_brand":0,"wds_primary_product_cat":0},"product_brand":[],"product_cat":[18],"product_tag":[427,428,267,300,48],"class_list":{"0":"post-127859","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-in-house","7":"product_tag-ce-marking","8":"product_tag-documentation","9":"product_tag-ivd","10":"product_tag-ivdr","11":"product_tag-risk","12":"pa_industry-ivd","13":"pa_language-english","14":"pa_level-intermediate","15":"pa_location-online","16":"pa_region-eu","18":"first","19":"instock","20":"virtual","21":"taxable","22":"purchasable","23":"product-type-simple"},"acf":[],"_links":{"self":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/product\/127859","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\/127867"}],"wp:attachment":[{"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/media?parent=127859"}],"wp:term":[{"taxonomy":"product_brand","embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/product_brand?post=127859"},{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/product_cat?post=127859"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/lightweb.dev\/s\/key2compliance\/wp-json\/wp\/v2\/product_tag?post=127859"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}