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woocommerce-product-gallery--columns-4 images" data-columns="4" style="opacity: 0; transition: opacity .25s ease-in-out;"> <div class="woocommerce-product-gallery__wrapper"> <div data-thumb="https://educolifesciences.com/wp-content/uploads/2021/02/course-page-1-300x300.jpg" data-thumb-alt="Fundamentals of the EU IVD Regulation (IVDR)" data-thumb-srcset="https://educolifesciences.com/wp-content/uploads/2021/02/course-page-1-300x300.jpg 300w, https://educolifesciences.com/wp-content/uploads/2021/02/course-page-1-150x150.jpg 150w, https://educolifesciences.com/wp-content/uploads/2021/02/course-page-1-570x570.jpg 570w, https://educolifesciences.com/wp-content/uploads/2021/02/course-page-1-500x500.jpg 500w, https://educolifesciences.com/wp-content/uploads/2021/02/course-page-1-1000x1000.jpg 1000w, https://educolifesciences.com/wp-content/uploads/2021/02/course-page-1-100x100.jpg 100w" data-thumb-sizes="(max-width: 300px) 100vw, 300px" class="woocommerce-product-gallery__image"><a 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small left qode-sp-separator"></div><p class="price"><del aria-hidden="true"><span class="woocommerce-Price-amount amount"><bdi><span class="woocommerce-Price-currencySymbol">£</span>1,195.00</bdi></span></del> <span class="screen-reader-text">Original price was: £1,195.00.</span><ins aria-hidden="true"><span class="woocommerce-Price-amount amount"><bdi><span class="woocommerce-Price-currencySymbol">£</span>795.00</bdi></span></ins><span class="screen-reader-text">Current price is: £795.00.</span></p> <div class="woocommerce-product-rating"> <div class="star-rating" role="img" aria-label="Rated 4.71 out of 5"><span style="width:94.2%">Rated <strong class="rating">4.71</strong> out of 5 based on <span class="rating">7</span> customer ratings</span></div> <a href="#reviews" class="woocommerce-review-link" rel="nofollow">(<span class="count">7</span> customer reviews)</a> </div> <div class="woocommerce-product-details__short-description"> <div class="vc_empty_space" style="height: 10px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div> <p><span style="color: #2274b5;"><strong>The price is for all modules | </strong></span><a href="#module-1-form">Register for Module 1 -Free</a></p> <p><strong>Gain a comprehensive overview of the IVD Regulation (IVDR) to ensure your diagnostics are compliant in the EU.</strong></p> </div> <form class="variations_form cart" action="https://educolifesciences.com/product/fundamentals-of-the-eu-ivd-regulation-ivdr-training-course/" method="post" enctype='multipart/form-data' data-product_id="1253" data-product_variations="[{"attributes":{"attribute_select-course-dates":"29 Sep 2025, Live Online"},"availability_html":"","backorders_allowed":false,"dimensions":{"length":"","width":"","height":""},"dimensions_html":"N\/A","display_price":795,"display_regular_price":1195,"image":{"title":"course page 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/> </div> <button type="submit" class="single_add_to_cart_button button alt">Enrol Now</button> <input type="hidden" name="add-to-cart" value="1253" /> <input type="hidden" name="product_id" value="1253" /> <input type="hidden" name="variation_id" class="variation_id" value="0" /> </div> </div> </form> </div> </div> </div> <div class="q_tabs horizontal center"> <ul class="tabs-nav"> <li class="description_tab"> <a href="#tab-description" role="tab" aria-controls="tab-description">Description</a> </li> <li class="reviews_tab"> <a href="#tab-reviews" role="tab" aria-controls="tab-reviews">Reviews (7)</a> </li> </ul> <div class="tabs-container"> <div class="tab-content" id="tab-description"> <div class="wpb-content-wrapper"><div data-q_id="#OurStory" class="vc_row wpb_row section vc_row-fluid grid_section" style=' padding-top:0px; padding-bottom:25px; text-align:left;'><div class=" section_inner clearfix"><div class='section_inner_margin clearfix'><div class="wpb_column vc_column_container vc_col-sm-8"><div class="vc_column-inner"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element vc_custom_1705671674881"> <div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h5>Register For Module 1 | Free-To-Attend</h5> <p> </p> <p>Module 1 of this course is free to attend and delivered online. Register to receive joining instructions for the live event, recording and presentation slides.</p> </div> </div> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"></div> </div> </div> </div><div class="vc_empty_space" style="height: 20px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div><a itemprop="url" href="#module-1-form" target="_self" class="qbutton default" style="">Register Free Now</a><div class="vc_empty_space" style="height: 70px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div></div></div></div><div class="wpb_column vc_column_container vc_col-sm-4"><div class="vc_column-inner"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h5>Register Early To Save</h5> <p> </p> <h4 style="text-align: left;">Enrol before 5 September to save £400 (2025 Dates)</h4> <p style="text-align: left;"><em>Discount has been applied to the price above. VAT, if applicable, will be added.</em></p> </div> </div></div></div></div></div></div></div><div data-q_id="#OurStory" class="vc_row wpb_row section vc_row-fluid grid_section" style=' padding-top:25px; padding-bottom:25px; text-align:left;'><div class=" section_inner clearfix"><div class='section_inner_margin clearfix'><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner"><div class="wpb_wrapper"><div class="vc_empty_space" style="height: 20px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p style="text-align: center;"><em><strong>Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.</strong></em></p> </div> </div> <div class="vc_empty_space"></div> </div> </div><div class="vc_empty_space" style="height: 20px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div><div class="qode-advanced-tabs qode-advanced-tabs qode-advanced-horizontal-tab clearfix qode-advanced-tab-without-icon qode-advanced-tabs-column-6 clearfix"> <ul class="qode-advanced-tabs-nav"> <li> <h2> <a href="#tab-course-overview"> <span class="qode-advanced-tab-text-after-icon"> Course Overview </span> </a> </h2> </li> <li> <h2> <a href="#tab-key-learning-objectives"> <span class="qode-advanced-tab-text-after-icon"> Key Learning Objectives </span> </a> </h2> </li> <li> <h2> <a href="#tab-what-is-included"> <span class="qode-advanced-tab-text-after-icon"> What is Included? </span> </a> </h2> </li> <li> <h2> <a href="#tab-course-dates"> <span class="qode-advanced-tab-text-after-icon"> Course Dates </span> </a> </h2> </li> <li> <h2> <a href="#tab-looking-to-train-your-team"> <span class="qode-advanced-tab-text-after-icon"> Looking to Train Your Team? </span> </a> </h2> </li> <li> <h2> <a href="#tab-other-course-info"> <span class="qode-advanced-tab-text-after-icon"> Other Course Info </span> </a> </h2> </li> </ul> <div class="qode-advanced-tab-container" id="tab-course-overview-284" data-icon-pack="" data-icon-html=""> <div class="wpb_text_column wpb_content_element vc_custom_1705671695858"> <div class="wpb_wrapper"> <h2>Course Overview</h2> <p> </p> <p>The In-Vitro Diagnostic Regulation (IVDR) was introduced by the EU to replace the In-Vitro Diagnostic Directive (IVDD). Like the MDR, the aim is to improve patient safety with more accurate diagnostics and more stringent post market surveillance procedures. For a sector so used to being self-certified, the IVDR is a huge change for IVD professionals who must now navigate much stricter regulations.</p> <p> </p> <p>This course provides you with a complete overview of the IVDR from economic operators and classification to working with a Notified Body and understanding conformity assessment routes. You will examine the key clauses of the new IVDR and its implementation in Europe. Once completed you will have the knowledge, skills and tools to carve out a transition strategy, ensuring your IVD product(s) remain compliant.</p> <p> </p> <p>With the Educo <strong><a href="https://educolifesciences.com/post-learning-implementation-plan/" target="_blank" rel="noopener">Post Learning Implementation Plan (PLIP)</a></strong> you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. <strong><a href="https://educolifesciences.com/live-online-training/" target="_blank" rel="noopener">Learn more about how we deliver live online training</a>. </strong>If you have any concerns about COVID-19 before registering on to the course,<strong><a href="https://educolifesciences.com/covid-19-policy/" target="_blank" rel="noopener">please read our COVID-19 commitment.</a></strong></p> </div> </div></div><div class="qode-advanced-tab-container" id="tab-key-learning-objectives-992" data-icon-pack="" data-icon-html=""> <div class="wpb_text_column wpb_content_element vc_custom_1705672667725"> <div class="wpb_wrapper"> <h2>Key Learning Objectives</h2> <p> </p> <ul> <li>Gain a complete overview of the new IVD Regulations (IVDR) to help you formulate a transition strategy from the IVD Directive (IVDD).</li> <li>Examine the key clauses in the IVD Regulation (IVDR) to ensure continued compliance and access to the European market.</li> <li>Fully comprehend the changes to the IVD industry and begin planning for a successful transition.</li> <li>Understand the importance of risk and quality management throughout the lifecycle of your diagnostic product</li> <li>Examine the conformity assessment routes and technical documentation required under the IVDR to ensure compliance</li> <li>Review the requirements for performance evaluation studies and clinical evidence under the IVDR</li> <li>Understand the latest labelling and UDI requirements for your diagnostic to minimise market access delays</li> </ul> </div> </div></div><div class="qode-advanced-tab-container" id="tab-what-is-included-762" data-icon-pack="" data-icon-html=""> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h2>What is Included in a Live Online Course?</h2> <p> </p> <ul> <li>Direct access to an expert trainer.</li> <li>Interactive and engaging sessions with exercises and discussions.</li> <li>Bitesize learning.</li> <li>Access to the Educo Life Sciences Training Portal.</li> <li>Unlimited access to the recordings for 4 to 5 weeks after the last session.</li> <li>A reinforcement session delivered 4 to 5 weeks after the course (online) providing you with extra time with the trainer.</li> <li>A validated certificate of attendance is available for you to download.</li> </ul> </div> </div></div><div class="qode-advanced-tab-container" id="tab-course-dates-1" data-icon-pack="" data-icon-html=""> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h2>Course Dates</h2> <p> </p> <p>Find out when this course is running so you can plan your training. Scroll down to view the full agenda.</p> </div> </div><div class="vc_empty_space" style="height: 20px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h4>w/c 29 September 2025</h4> <p><strong>1 Week Live Online Training</strong><br /> Register at the top of the page.</p> </div> </div></div><div class="qode-advanced-tab-container" id="tab-looking-to-train-your-team-559" data-icon-pack="" data-icon-html=""> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h2><strong>Group Discount</strong></h2> <p> </p> <p>If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.</p> <p> </p> <p style="text-align: left;">For a quote, complete our contact form by following the link. <a href="https://educolifesciences.com/contact/" target="_blank" rel="noopener"><strong>Get in touch.</strong></a></p> </div> </div><div class="vc_empty_space" style="height: 50px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h2><strong>Customised Team Training</strong></h2> <p> </p> <p>We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.</p> <p> </p> <p style="text-align: left;">For more information, complete our contact form by following the link. <a href="https://educolifesciences.com/contact/" target="_blank" rel="noopener"><strong>Get in touch.</strong></a></p> </div> </div></div><div class="qode-advanced-tab-container" id="tab-other-course-info-818" data-icon-pack="" data-icon-html=""> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h2><strong>Free Online</strong><strong> Module</strong></h2> <p> </p> <ul> <li>Module 1 is free to attend and delivered online at a date 3 to 8 weeks before the full course start date.</li> <li>To register for module 1, please submit your details in the form located in the agenda.</li> <li>Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.</li> </ul> <p> </p> <h2><strong>Full Course Information and Pricing</strong></h2> <p> </p> <ul> <li>To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.</li> <li>There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.</li> <li>The full training course is delivered either online or in a classroom. Please check which course format you have booked.</li> <li>For hybrid training – In the event we do not have enough people on one of the options we will contact you to discuss switching.</li> <li>For live online courses – The dates and times of modules/sessions are subject to change.</li> <li>For live online courses – The module/session durations are approximate.</li> </ul> <p> </p> <p><a href="https://educolifesciences.com/faqs/" target="_blank" rel="noopener">Frequently Asked Questions (FAQs)</a></p> </div> </div></div></div></div></div></div></div></div></div><div data-q_id="#about" class="vc_row wpb_row section vc_row-fluid grid_section" style=' padding-top:20px; padding-bottom:20px; text-align:left;'><div class=" section_inner clearfix"><div class='section_inner_margin clearfix'><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner"><div class="wpb_wrapper"><div class="vc_empty_space" style="height: 30px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p style="margin: 0in; font-family: Calibri; font-size: 11pt; text-align: center;"><strong><em>Learn more about the course by toggling through the tabs below (Agenda, Trainer and Who Should Attend?)</em></strong></p> </div> </div><div class="vc_empty_space" style="height: 10px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div><div class="vc_empty_space" style="height: 10px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div><div class="qode-advanced-tabs qode-advanced-tabs qode-advanced-horizontal-tab clearfix qode-advanced-tab-without-icon qode-advanced-tabs-column-3 clearfix"> <ul class="qode-advanced-tabs-nav"> <li> <h2> <a href="#tab-agenda"> <span class="qode-advanced-tab-text-after-icon"> Agenda </span> </a> </h2> </li> <li> <h2> <a href="#tab-trainer"> <span class="qode-advanced-tab-text-after-icon"> Trainer </span> </a> </h2> </li> <li> <h2> <a href="#tab-who-should-attend"> <span class="qode-advanced-tab-text-after-icon"> Who Should Attend? </span> </a> </h2> </li> </ul> <div class="qode-advanced-tab-container" id="tab-agenda-344" data-icon-pack="" data-icon-html=""> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> </div> </div><div class="vc_row wpb_row section vc_row-fluid vc_inner " style=' padding-top:16px; padding-bottom:16px; text-align:left;'><div class=" full_section_inner clearfix"><div class="wpb_column vc_column_container vc_col-sm-3"><div class="vc_column-inner"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h5>Post Learning Implementation Plan (PLIP)</h5> </div> </div></div></div></div><div class="wpb_column vc_column_container vc_col-sm-9"><div class="vc_column-inner"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p><span style="font-weight: bold;">Pre-course</span></p> <ul> <li>Access to the Educo Training Portal</li> <li>Submit your needs analysis and objectives for training by completing a simple online form</li> </ul> <p><strong>Action Plan</strong></p> <ul> <li>At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge</li> </ul> <p><strong>Reinforcement Session </strong></p> <ul> <li>Delivered 3 to 4 weeks after the training</li> <li>It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges</li> </ul> </div> </div></div></div></div></div></div><div class="vc_row wpb_row section vc_row-fluid vc_inner " style=' padding-top:16px; padding-bottom:16px; text-align:left;'><div class=" full_section_inner clearfix"><div class="wpb_column vc_column_container vc_col-sm-3"><div class="vc_column-inner"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h5 id="module-1-form">Introductory Module 1</h5> <h5>FREE to Attend | Live & Recorded</h5> <p><strong>4 September 2025 | 60 mins | 12:00 PM UK</strong></p> </div> </div></div></div></div><div class="wpb_column vc_column_container vc_col-sm-9"><div class="vc_column-inner"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p><strong>Introduction to the IVDR</strong></p> <ul> <li>Introduction to the EU Regulations: <ul> <li>Structure of the regulation</li> <li>Different types of regulation used by the Commission</li> <li>CE marking</li> </ul> </li> <li>What will be the impact of the new IVD Regulation?</li> <li>Quality Management Requirements</li> <li>Who is involved? <ul> <li>Competent Authorities / Notified Bodies</li> <li>Economic Operators</li> </ul> </li> </ul> </div> </div><div class="vc_empty_space" style="height: 35px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h3>Register For Module 1 | Free</h3> <p>There are limited spaces on module 1. 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">Register Now</button> </div> </div> </form> </div> </div> </div></div></div></div></div></div><div class="vc_row wpb_row section vc_row-fluid vc_inner " style=' padding-top:16px; padding-bottom:16px; text-align:left;'><div class=" full_section_inner clearfix"><div class="wpb_column vc_column_container vc_col-sm-3"><div class="vc_column-inner"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h5>Module 2 & 3</h5> <p><strong>29 September 2025 | 180 mins | 12:00 PM UK</strong></p> </div> </div></div></div></div><div class="wpb_column vc_column_container vc_col-sm-9"><div class="vc_column-inner"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p><strong>A risk based approach</strong></p> <ul> <li>Review of Product Classification</li> <li>Risk Management</li> </ul> <p> </p> <p><strong>General safety and performance requirements</strong></p> <ul> <li>Overview of the sections</li> <li>Impacts for manufacturing and software</li> <li>The use of Standards</li> </ul> </div> </div><div class="vc_empty_space" style="height: 30px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p><strong>Compiling your technical documentation</strong></p> <ul> <li>The use of product families</li> <li>What is the difference between a Technical File and Design Dossier?</li> <li>What is needed for each document?</li> <li>How to proceed to CE Marking</li> </ul> </div> </div></div></div></div></div></div><div class="vc_row wpb_row section vc_row-fluid vc_inner " style=' padding-top:16px; padding-bottom:16px; text-align:left;'><div class=" full_section_inner clearfix"><div class="wpb_column vc_column_container vc_col-sm-3"><div class="vc_column-inner"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h5>Module 4 & 5</h5> <p><strong>30 September 2025 | 180 mins | 12:00 PM UK</strong></p> </div> </div></div></div></div><div class="wpb_column vc_column_container vc_col-sm-9"><div class="vc_column-inner"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p><strong>Post-Market Surveillance (PMS) and vigilance responsibilities</strong></p> <ul> <li>What the Regulation says regarding: <ul> <li>Incidents</li> <li>Post-market surveillance</li> <li>Post production experience</li> </ul> </li> <li>How should the quality system interface with vigilance requirements?</li> <li>Review of the MEDDEV guidelines</li> <li>In depth review of PMS strategies</li> </ul> </div> </div><div class="vc_empty_space" style="height: 30px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p><strong>Documentations, clinical evidence and clinical performance of diagnostics in the EU</strong></p> <ul> <li>Review of the regulation</li> <li>Overview of the standard</li> <li>When is a clinical study needed?</li> <li>What is needed for the Competent Authority and Ethics Committee submissions?</li> </ul> </div> </div><div class="vc_empty_space" style="height: 30px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div></div></div></div></div></div><div class="vc_row wpb_row section vc_row-fluid vc_inner " style=' padding-top:16px; padding-bottom:16px; text-align:left;'><div class=" full_section_inner clearfix"><div class="wpb_column vc_column_container vc_col-sm-3"><div class="vc_column-inner"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h5>Module 6 & 7</h5> <p><strong>1 October 2025 | 180 mins | 12:00 PM UK</strong></p> </div> </div></div></div></div><div class="wpb_column vc_column_container vc_col-sm-9"><div class="vc_column-inner"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p><strong>Product verification and validation</strong></p> <ul> <li>Conformity testing activities: <ul> <li>Product Performance testing</li> <li>Testing strategies</li> <li>Usability Assessment</li> </ul> </li> </ul> </div> </div><div class="vc_empty_space" style="height: 30px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p><strong>Labelling of IVDs</strong></p> <ul> <li>Requirements from GSPR</li> <li>Use of language and symbols</li> <li>Translations</li> <li>Instructions for use</li> <li>Symbols</li> <li>Electronic labelling</li> <li>Examining Unique Device Identification (UDI)</li> </ul> </div> </div><div class="vc_empty_space" style="height: 30px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div></div></div></div></div></div><div class="vc_row wpb_row section vc_row-fluid vc_inner " style=' padding-top:16px; padding-bottom:16px; text-align:left;'><div class=" full_section_inner clearfix"><div class="wpb_column vc_column_container vc_col-sm-3"><div class="vc_column-inner"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h5>Module 8</h5> <p><strong>2 October 2025 | 90 mins | 12:00 PM UK</strong></p> </div> </div></div></div></div><div class="wpb_column vc_column_container vc_col-sm-9"><div class="vc_column-inner"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p><strong>Conformity assessment</strong></p> <ul> <li>Conformity Assessment routes: <ul> <li>Optional routes for each class of device</li> <li>What is required for each Conformity Assessment Annex?</li> <li>An overview of IVD routes</li> <li>Impact of the In Vitro Diagnostics Device Regulation (IVDR)</li> </ul> </li> </ul> </div> </div></div></div></div></div></div></div><div class="qode-advanced-tab-container" id="tab-trainer-517" data-icon-pack="" data-icon-html=""><div class="vc_row wpb_row section vc_row-fluid vc_inner " style=' text-align:left;'><div class=" full_section_inner clearfix"><div class="wpb_column vc_column_container vc_col-sm-3"><div class="vc_column-inner"><div class="wpb_wrapper"><noscript><img width="150" height="150" decoding="async" src="https://educolifesciences.com/wp-content/uploads/2021/03/Trainer-pic-2.png" /></noscript><img class="lazyload" width="150" height="150" decoding="async" src='data:image/svg+xml,%3Csvg%20xmlns=%22http://www.w3.org/2000/svg%22%20viewBox=%220%200%20150%20150%22%3E%3C/svg%3E' data-src="https://educolifesciences.com/wp-content/uploads/2021/03/Trainer-pic-2.png" /></div></div></div><div class="wpb_column vc_column_container vc_col-sm-9"><div class="vc_column-inner"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p><strong>Richard Young</strong> has over 20 years’ experience in the medical device and IVD industry with products such as class 3 implants to electromedical infusion systems. Richard has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director, Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited.</p> <p> </p> <p>Richard has been an independent consultant for over 6 years, supporting companies with regulatory and quality advice on a range of different products. He has extensive experience of European regulations including the MDD, IVDD and more recently the MDR and IVDR. In addition, Richard understands the US FDA requirements for devices and diagnostics. He also has a comprehensive working knowledge of device ISO standards such as 13485 and 14971.</p> <p> </p> <p>Richard has delivered both online and classroom training courses on devices and IVDs. He can provide multiple examples and case studies during training, drawing on his extensive industry experience. This helps delegates understand regulatory and quality concepts.</p> </div> </div></div></div></div></div></div></div><div class="qode-advanced-tab-container" id="tab-who-should-attend-68" data-icon-pack="" data-icon-html=""> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p>This course is suitable for professionals who work in or are new to the In Vitro Diagnostic (IVD) industry and require a complete overview of the new In Vitro Diagnostic Regulation (IVDR).</p> <p>These include:</p> <ul> <li>Regulatory Affairs</li> <li>Quality</li> <li>Design & Development</li> <li>Clinical</li> <li>Management</li> <li>Device Manufacturers</li> <li>Device Distributors</li> <li>Professionals new to IVD regulations from devices or pharma.</li> </ul> </div> </div></div></div></div></div></div></div></div></div> </div> </div> <div class="tab-content" id="tab-reviews"> <div id="reviews" class="woocommerce-Reviews"> <div id="comments"> <h2 class="woocommerce-Reviews-title"> 7 reviews for <span><H2>Fundamentals of the EU IVD Regulation (IVDR)</H2> <H4>29 September 2025 | 1 Week Live Online Course</H4></span> </h2> <ol class="commentlist"> <li class="review even thread-even depth-1" id="li-comment-1979"> <div id="comment-1979" class="comment_container"> <div class="comment-text"> <div class="star-rating" role="img" aria-label="Rated 5 out of 5"><span style="width:100%">Rated <strong class="rating">5</strong> out of 5</span></div> <p class="meta"> <strong class="woocommerce-review__author">Calibre Scientific </strong> <span class="woocommerce-review__dash">–</span> <time class="woocommerce-review__published-date" datetime="2022-02-27T15:22:43+00:00">February 27, 2022</time> </p> <div class="description"><p>I totally enjoyed the course, the trainer was very prepared and answered all our questions. I will definitely use educo for future training purposes.</p> </div> </div> </div> </li> <li class="review odd alt thread-odd thread-alt depth-1" id="li-comment-1980"> <div id="comment-1980" class="comment_container"> <div class="comment-text"> <div class="star-rating" role="img" aria-label="Rated 5 out of 5"><span style="width:100%">Rated <strong class="rating">5</strong> out of 5</span></div> <p class="meta"> <strong class="woocommerce-review__author">London Medical Laboratory </strong> <em class="woocommerce-review__verified verified">(verified owner)</em> <span class="woocommerce-review__dash">–</span> <time class="woocommerce-review__published-date" datetime="2022-03-23T15:23:05+00:00">March 23, 2022</time> </p> <div class="description"><p>The course contained very high quality content. Covered a lot of things that are relevant to what I need and what I was looking for.</p> </div> </div> </div> </li> <li class="review even thread-even depth-1" id="li-comment-1974"> <div id="comment-1974" class="comment_container"> <div class="comment-text"> <div class="star-rating" role="img" aria-label="Rated 5 out of 5"><span style="width:100%">Rated <strong class="rating">5</strong> out of 5</span></div> <p class="meta"> <strong class="woocommerce-review__author">MGI Tech </strong> <span class="woocommerce-review__dash">–</span> <time class="woocommerce-review__published-date" datetime="2022-10-19T15:18:20+00:00">October 19, 2022</time> </p> <div class="description"><p>I was pleasantly surprised how effective and oriented the two-way communication was during this course . The lecturer was very responsive, answered all questions.</p> </div> </div> </div> </li> <li class="review odd alt thread-odd thread-alt depth-1" id="li-comment-1975"> <div id="comment-1975" class="comment_container"> <div class="comment-text"> <div class="star-rating" role="img" aria-label="Rated 5 out of 5"><span style="width:100%">Rated <strong class="rating">5</strong> out of 5</span></div> <p class="meta"> <strong class="woocommerce-review__author">Andromedia Lean Consultants </strong> <em class="woocommerce-review__verified verified">(verified owner)</em> <span class="woocommerce-review__dash">–</span> <time class="woocommerce-review__published-date" datetime="2022-10-19T15:19:11+00:00">October 19, 2022</time> </p> <div class="description"><p>I was due to attend in person, but couldn’t due to catching Covid, so I was very grateful to be able to change to online attendance at the last minute. I found it very useful.</p> </div> </div> </div> </li> <li class="review even thread-even depth-1" id="li-comment-1976"> <div id="comment-1976" class="comment_container"> <div class="comment-text"> <div class="star-rating" role="img" aria-label="Rated 5 out of 5"><span style="width:100%">Rated <strong class="rating">5</strong> out of 5</span></div> <p class="meta"> <strong class="woocommerce-review__author">National Standards Authority of Ireland (NSAI) </strong> <span class="woocommerce-review__dash">–</span> <time class="woocommerce-review__published-date" datetime="2022-10-20T15:20:02+00:00">October 20, 2022</time> </p> <div class="description"><p>I am delighted to have got this opportunity to attend the EUIVDR course. It was excellent. I attended remotely and was provided with a wealth of knowledge, experience and answers to even the most basic questions by the trainer. His insights and experience are extremely valuable, and I would definitely want to sign up for more of these sessions in the future. The presentation was clear, interactive and practical</p> </div> </div> </div> </li> <li class="review odd alt thread-odd thread-alt depth-1" id="li-comment-1978"> <div id="comment-1978" class="comment_container"> <div class="comment-text"> <div class="star-rating" role="img" aria-label="Rated 4 out of 5"><span style="width:80%">Rated <strong class="rating">4</strong> out of 5</span></div> <p class="meta"> <strong class="woocommerce-review__author">Saudi Food and Drug Authority (SFDA) </strong> <span class="woocommerce-review__dash">–</span> <time class="woocommerce-review__published-date" datetime="2022-10-20T15:22:08+00:00">October 20, 2022</time> </p> <div class="description"><p>n/a</p> </div> </div> </div> </li> <li class="review even thread-even depth-1" id="li-comment-1977"> <div id="comment-1977" class="comment_container"> <div class="comment-text"> <div class="star-rating" role="img" aria-label="Rated 4 out of 5"><span style="width:80%">Rated <strong class="rating">4</strong> out of 5</span></div> <p class="meta"> <strong class="woocommerce-review__author">Novo Nordisk </strong> <span class="woocommerce-review__dash">–</span> <time class="woocommerce-review__published-date" datetime="2022-11-09T15:21:36+00:00">November 9, 2022</time> </p> <div class="description"><p>n/a</p> </div> </div> </div> </li> </ol> </div> <div id="review_form_wrapper"> <div id="review_form"> <div id="respond" class="comment-respond"> <span id="reply-title" class="comment-reply-title">Add a review</span><form action="https://educolifesciences.com/wp-comments-post.php" method="post" id="commentform" class="comment-form"><p class="comment-notes"><span id="email-notes">Your email address will not be published.</span> <span class="required-field-message">Required fields are marked <span class="required">*</span></span></p><div class="comment-form-rating"><label for="rating">Your rating <span class="required">*</span></label><select name="rating" id="rating" required> <option 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