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class="woocommerce-product-gallery woocommerce-product-gallery--with-images 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/Device-course-page-14-300x300.jpg" data-thumb-alt="" data-thumb-srcset="https://educolifesciences.com/wp-content/uploads/2021/02/Device-course-page-14-300x300.jpg 300w, https://educolifesciences.com/wp-content/uploads/2021/02/Device-course-page-14-100x100.jpg 100w, https://educolifesciences.com/wp-content/uploads/2021/02/Device-course-page-14-150x150.jpg 150w, https://educolifesciences.com/wp-content/uploads/2021/02/Device-course-page-14-570x570.jpg 570w, https://educolifesciences.com/wp-content/uploads/2021/02/Device-course-page-14-500x500.jpg 500w, https://educolifesciences.com/wp-content/uploads/2021/02/Device-course-page-14-1000x1000.jpg 1000w" class="woocommerce-product-gallery__image"><a href="https://educolifesciences.com/wp-content/uploads/2021/02/Device-course-page-14.jpg"><img width="600" height="400" src="https://educolifesciences.com/wp-content/uploads/2021/02/Device-course-page-14-600x400.jpg" class="wp-post-image" alt="" data-caption="" data-src="https://educolifesciences.com/wp-content/uploads/2021/02/Device-course-page-14.jpg" data-large_image="https://educolifesciences.com/wp-content/uploads/2021/02/Device-course-page-14.jpg" data-large_image_width="1920" data-large_image_height="1281" decoding="async" fetchpriority="high" srcset="https://educolifesciences.com/wp-content/uploads/2021/02/Device-course-page-14-600x400.jpg 600w, https://educolifesciences.com/wp-content/uploads/2021/02/Device-course-page-14-300x200.jpg 300w, https://educolifesciences.com/wp-content/uploads/2021/02/Device-course-page-14-1024x683.jpg 1024w, https://educolifesciences.com/wp-content/uploads/2021/02/Device-course-page-14-768x512.jpg 768w, https://educolifesciences.com/wp-content/uploads/2021/02/Device-course-page-14-1536x1025.jpg 1536w, https://educolifesciences.com/wp-content/uploads/2021/02/Device-course-page-14-700x467.jpg 700w, https://educolifesciences.com/wp-content/uploads/2021/02/Device-course-page-14.jpg 1920w" sizes="(max-width: 600px) 100vw, 600px" /></a></div> </div> </div> <div class="qode-single-product-summary"> <div class="summary entry-summary"> <div class="clearfix"> <div class="product-categories"><a href="https://educolifesciences.com/product-category/ivd-training/" rel="tag">IVD Courses</a>, <a href="https://educolifesciences.com/product-category/medical-device-and-ivd-training/" rel="tag">Medical Device & IVD Courses</a>, <a href="https://educolifesciences.com/product-category/medical-device-regulation-training/" rel="tag">Regulatory Courses</a></div><h1 class="product_title entry-title"><H2>Labelling and UDI for Medical Devices and IVDs</H2> <H4>12 May 2025 | 1 Week Live Online Course</H4></h1><div class="separator 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>1,295.00</bdi></span></del> <span class="screen-reader-text">Original price was: £1,295.00.</span><ins aria-hidden="true"><span class="woocommerce-Price-amount amount"><bdi><span class="woocommerce-Price-currencySymbol">£</span>895.00</bdi></span></ins><span class="screen-reader-text">Current price is: £895.00.</span></p> <div class="woocommerce-product-rating"> <div class="star-rating" role="img" aria-label="Rated 4.50 out of 5"><span style="width:90%">Rated <strong class="rating">4.50</strong> out of 5 based on <span class="rating">6</span> customer ratings</span></div> <a href="#reviews" class="woocommerce-review-link" rel="nofollow">(<span class="count">6</span> customer reviews)</a> </div> <div class="woocommerce-product-details__short-description"> <p style="margin: 0in; font-family: Calibri; font-size: 11.0pt;"><div class="vc_empty_space" style="height: 10px" > <span class="vc_empty_space_inner"> <span class="empty_space_image" ></span> </span> </div></p> <p><strong><span style="color: #2274b5;">The price is for all sessions below</span></strong> | <a href="#module-1-form">Register for Module 1 – Free</a></p> <p>Fully understand medical device and IVD labelling and UDI requirements to ensure your product is MDR/IVDR compliant.</p> </div> <form class="variations_form cart" action="https://educolifesciences.com/product/labelling-and-udi-for-medical-devices-and-ivds-training-course/" method="post" enctype='multipart/form-data' data-product_id="1273" data-product_variations="[{"attributes":{"attribute_select-course-dates":"12 May 2025, Live 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Online"},"availability_html":"","backorders_allowed":false,"dimensions":{"length":"","width":"","height":""},"dimensions_html":"N\/A","display_price":895,"display_regular_price":1295,"image":{"title":"Device course page (14)","caption":"","url":"https:\/\/educolifesciences.com\/wp-content\/uploads\/2021\/02\/Device-course-page-14.jpg","alt":"Device course page (14)","src":"https:\/\/educolifesciences.com\/wp-content\/uploads\/2021\/02\/Device-course-page-14-600x400.jpg","srcset":"https:\/\/educolifesciences.com\/wp-content\/uploads\/2021\/02\/Device-course-page-14-600x400.jpg 600w, https:\/\/educolifesciences.com\/wp-content\/uploads\/2021\/02\/Device-course-page-14-300x200.jpg 300w, https:\/\/educolifesciences.com\/wp-content\/uploads\/2021\/02\/Device-course-page-14-1024x683.jpg 1024w, https:\/\/educolifesciences.com\/wp-content\/uploads\/2021\/02\/Device-course-page-14-768x512.jpg 768w, 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id="select-course-dates" class="" name="attribute_select-course-dates" data-attribute_name="attribute_select-course-dates" data-show_option_none="yes"><option value="">Choose an option</option><option value="12 May 2025, Live Online" >12 May 2025, Live Online</option><option value="10 Nov 2025, Live Online" >10 Nov 2025, Live Online</option></select><a class="reset_variations" href="#">Clear</a> </td> </tr> </tbody> </table> <div class="single_variation_wrap"> <div class="woocommerce-variation single_variation"></div><div class="woocommerce-variation-add-to-cart variations_button"> <div class="quantity buttons_added"> <label class="screen-reader-text" for="quantity_6747994740211">Labelling and UDI for Medical Devices and IVDs quantity</label> <input type="button" value="-" class="minus" /> <input type="text" id="quantity_6747994740211" step="1" min="1" max="89" name="quantity" value="1" aria-label="Qty" class="input-text qty text" pattern="[0-9]*" inputmode="numeric" aria-labelledby="Labelling and UDI for Medical Devices and IVDs quantity" /> <input type="button" value="+" class="plus" /> </div> <button type="submit" class="single_add_to_cart_button button alt">Enrol Now</button> <input type="hidden" name="add-to-cart" value="1273" /> <input type="hidden" name="product_id" value="1273" /> <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">Description</a> </li> <li class="additional_information_tab"> <a href="#tab-additional_information">Additional Information</a> </li> <li class="reviews_tab"> <a href="#tab-reviews">Reviews (6)</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_1705509161812"> <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="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 11 April to save £400</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-617" data-icon-pack="" data-icon-html=""> <div class="wpb_text_column wpb_content_element vc_custom_1705509243969"> <div class="wpb_wrapper"> <h2>Course Overview</h2> <p> </p> <p>Medical Device and IVD labelling are areas that have been significantly impacted by the MDR and IVDR. To improve patient safety labelling requirements have been revamped with the introduction of Unique Device Identification (UDI), EDAMED database and expanded content requirements.</p> <p> </p> <p>This Medical Device and IVD labelling training course will develop your knowledge and skills so you have the confidence to navigate the latest requirements. You will examine major new elements such as UDI requirements, label requirements and how the label is related to the EUDAMED database, PMS and risk management. Once completed you will have the ability to develop strategies to transition smoothly to the new requirements under the MDR and IVDR.</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></p> </div> </div></div><div class="qode-advanced-tab-container" id="tab-key-learning-objectives-21" data-icon-pack="" data-icon-html=""> <div class="wpb_text_column wpb_content_element vc_custom_1705509327161"> <div class="wpb_wrapper"> <h2>Key Learning Objectives</h2> <p> </p> <ul> <li>Examine the labelling requirements under the MDR and IVDR to ensure your label follows regulatory guidelines</li> <li>Learn what information must go on the label at each stage of packaging to ensure your device/diagnostic is compliant</li> <li>Assess differences in labelling requirements between the new Regulations (MDR / IVDR) and previous Directives</li> <li>Understand the Instructions For Use (IFU) and eIFU to ensure your label is compliant.</li> <li>Gain an awareness of the US labelling requirements and the implications of Brexit for manufacturers</li> <li>Analyse specific case study examples including single-use devices, sterilisation labels, implantable devices and hazard warnings</li> <li>Gain a comprehensive understanding of Unique Device Identification (UDI) in order to implement effectively</li> <li>Discover how labelling requirements impact other major regulatory areas such as risk management and PMS</li> <li>Understand the quality and regulatory implications of making labelling and Instructions For Use available on the manufacturer’s website</li> </ul> </div> </div></div><div class="qode-advanced-tab-container" id="tab-what-is-included-85" 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-246" 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 12 May 2025</h4> <p><strong>1 Week Live Online Training</strong></p> <p>Register at the top of the page. The largest price saving of £400 will be applied.</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 10 November 2025</h4> <p><strong>1 Week Live Online Training</strong></p> <p>Register at the top of the page. The largest price saving of £400 will be applied.</p> </div> </div></div><div class="qode-advanced-tab-container" id="tab-looking-to-train-your-team-425" 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-634" 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:25px; 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="text-align: center;"><em><strong>Learn more about the course by toggling through the tabs below (Agenda, Trainer and Who Should Attend?)</strong></em></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="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-852" 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>Sign up</strong></p> <p><strong>1 April 2025 | 60 mins | 1:00 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="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>Introduction and overview </strong></p> <ul> <li>Examine the labelling requirements under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)</li> <li>Highlight the main differences between the directive and the new Regulations.</li> </ul> <p> </p> <p> </p> <h3>Register For Module 1 | Free</h3> <p>There are limited spaces on module 1. 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data-happyforms-required=""> <div class="happyforms-part-wrap"> <div class="happyforms-part__label-container"> <label for="happyforms-2035_single_line_text_9" class="happyforms-part__label"> <span class="label">Country</span> <span class="happyforms-required"></span> </label> </div> <div class="happyforms-part__el"> <div class="happyforms-input"> <input id="happyforms-2035_single_line_text_9" type="text" name="2035_single_line_text_9" value="" placeholder="" autocomplete="off" spellcheck="false" autocorrect="off" /> </div> </div> </div> </div> <div class="happyforms-form__part happyforms-part happyforms-part--placeholder happyforms-part--width-full happyforms-part--label-show" id="happyforms-2035_placeholder_10-part" data-happyforms-type="placeholder" data-happyforms-id="placeholder_10"> <div class="happyforms-part-wrap"> <div class="happyforms-part__el"> <p>By clicking register, you agree to our <a href="https://educolifesciences.com/privacy-policy/" target="_blank" rel="noopener">Privacy Policy</a></p> </div> </div> </div> <div class="happyforms-form__part happyforms-part happyforms-part--submit"> <button type="submit" class="happyforms-submit happyforms-button--submit ">Register Now</button> </div> </div> </form> </div> <p> </p> </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>Session 1</h5> <p><strong>12 May 2025 | 180 mins | 1:00 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>Examine specific changes in labelling requirements for Devices and IVDs</strong></p> <ul> <li>Examine and review <ul> <li>Level of information instruction going on the label</li> <li>What information is required for these changes?</li> <li>Harmonised symbols</li> <li>The challenges with symbols and translation</li> </ul> </li> <li>Learn the requirements for each stage of packaging <ul> <li>Review of labelling and packaging requirements at each stage of packaging</li> <li>Stages include: Instructions for Use (IFU), primary packaging, secondary packaging, tertiary packaging and pallet</li> </ul> </li> <li>Review and discuss <ul> <li>Examine electronic labelling</li> <li>Publishing labelling on your website</li> <li>Label printing</li> </ul> </li> <li>Examine the requirements in the US, highlighting key differences</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>Applications of labelling in the product life cycle</strong></p> <p>This session is designed to review examples of labelling for specific products including:</p> <ul> <li>Single-use devices</li> <li>Sterilisation</li> <li>Implantable devices</li> <li>Clinical investigation</li> <li>Hazard warnings</li> <li>Storage temperature</li> <li>Economic operators</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>Session 2</h5> <p><strong>13 May 2025 | 180 mins | 1:00 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>Usability assessment and instructions for use (IFU)</strong></p> <ul> <li>Review of the usability requirements compared with those from the Medical Device Directive (MDD)</li> <li>Assess Instructions For Use (IFU) and how to ensure they meet usability requirements</li> <li>Understand the electronic Instructions For Use eIFU</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 development and maintenance interfaces</strong></p> <p>In this session you will examine how labelling is impacts other process functions such as post market surveillance, risk management and design development.</p> <ul> <li>Labelling and Post Market Surveillance (PMS)</li> <li>Labelling and design development</li> <li>Labelling and risk management</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>Session 3</h5> <p><strong>14 May 2025 | 180 mins | 1:00 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>Examining Unique Device Identification (UDI) and EUDAMED requirements</strong></p> <ul> <li>Definition of UDI</li> <li>Why was UDI introduced?</li> <li>Gain a complete regulatory understanding of UDI</li> <li>Examine strategies for achieving UDI success</li> <li>Identify the differences between existing US system and the new EU system</li> <li>Global UDI and database insights (GUDID)</li> <li>Learn how to register your UDI</li> <li>EUDAMED considerations: <ul> <li>Learn how UDI is linked to the new EUDAMED database</li> <li>Examine the requirements in the US</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>Global labelling requirements</strong></p> <ul> <li>Strategies to get your labelling globally accepted</li> <li>Implementation of a label strategy</li> <li>Best practice working with an overseas supply chain/ manufacturer</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>Session 4</h5> <p><strong>15 May 2025 | 90 mins | 1:00 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="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>Brexit and the impact on labelling requirements</strong></p> <p>This session will examine how Brexit impacts labelling for both UK ad EU countries looking access both markets.</p> <ul> <li>Brexit and labelling and the UKCA marking</li> <li>Is the UK following same rules as the EU?</li> <li>Will the CE mark need to be on the label?</li> </ul> </div> </div></div></div></div></div></div></div><div class="qode-advanced-tab-container" id="tab-trainer-821" 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 decoding="async" class="alignnone wp-image-1523 size-full" src="https://educolifesciences.com/wp-content/uploads/2021/03/Trainer-pic-2.png" alt="" width="150" height="150" srcset="https://educolifesciences.com/wp-content/uploads/2021/03/Trainer-pic-2.png 150w, https://educolifesciences.com/wp-content/uploads/2021/03/Trainer-pic-2-100x100.png 100w" sizes="(max-width: 150px) 100vw, 150px" /></noscript><img decoding="async" class="lazyload alignnone wp-image-1523 size-full" 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" alt="" width="150" height="150" data-srcset="https://educolifesciences.com/wp-content/uploads/2021/03/Trainer-pic-2.png 150w, https://educolifesciences.com/wp-content/uploads/2021/03/Trainer-pic-2-100x100.png 100w" data-sizes="(max-width: 150px) 100vw, 150px" /></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 25 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>In a changing regulatory environment, communication with customers and end users is a critical element for all manufacturers in the life sciences sector. The content of labelling and internet communications is a vitally important part of the development and maintenance of compliance of all medical products. Richard has extensive experience in regulatory and quality roles for all classes of medical products and offers you a unique insight into the practicalities and requirements of labelling in todays markets.</p> </div> </div></div></div></div></div></div></div><div class="qode-advanced-tab-container" id="tab-who-should-attend-848" data-icon-pack="" data-icon-html=""> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p>This training course is designed for regulatory professionals who are involved in labelling of devices and diagnostics. These include:</p> <ul> <li>Regulatory Affairs</li> <li>Quality</li> <li>Project managers</li> <li>Product Launch Team</li> <li>Design and Development Team</li> <li>Manufacturers</li> <li>Distributors</li> </ul> </div> </div></div></div></div></div></div></div></div></div> </div> </div> <div class="tab-content" id="tab-additional_information"> <table class="woocommerce-product-attributes shop_attributes" aria-label="Product Details"> <tr class="woocommerce-product-attributes-item woocommerce-product-attributes-item--attribute_"> <th class="woocommerce-product-attributes-item__label" scope="row">*</th> <td class="woocommerce-product-attributes-item__value"><p>• The training course is delivered either online or in a classroom. Please check which course format you have booked.<br /> • For live online courses, dates and times of modules are subject to change<br /> • Please contact us for the module dates of future deliveries.<br /> • For live online courses, module durations are approximate.</p> </td> </tr> </table> </div> <div class="tab-content" id="tab-reviews"> <div id="reviews" class="woocommerce-Reviews"> <div id="comments"> <h2 class="woocommerce-Reviews-title"> 6 reviews for <span><H2>Labelling and UDI for Medical Devices and IVDs</H2> <H4>12 May 2025 | 1 Week Live Online Course</H4></span> </h2> <ol class="commentlist"> <li class="review even thread-even depth-1" id="li-comment-1773"> <div id="comment-1773" 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">Individual Booking </strong> <span class="woocommerce-review__dash">–</span> <time class="woocommerce-review__published-date" datetime="2022-09-23T08:45:27+00:00">September 23, 2022</time> </p> <div class="description"><p>n/a</p> </div> </div> </div> </li> <li class="review odd alt thread-odd thread-alt depth-1" id="li-comment-1862"> <div id="comment-1862" 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">Certification Company </strong> <span class="woocommerce-review__dash">–</span> <time class="woocommerce-review__published-date" datetime="2022-09-26T13:13:18+00:00">September 26, 2022</time> </p> <div class="description"><p>The trainer is a strong communicator, with experience shining through his every word. He shared information at a high level, in a comprehensible and practical way. I am very pleased with the content of this course, and am ever-grateful to the trainer for sharing his expertise, and for the passion, drive and ethics he displays. An inspiration to listen to and learn from. Thank you!</p> </div> </div> </div> </li> <li class="review even thread-even depth-1" id="li-comment-1863"> <div id="comment-1863" 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">Hologic </strong> <span class="woocommerce-review__dash">–</span> <time class="woocommerce-review__published-date" datetime="2022-09-28T13:13:42+00:00">September 28, 2022</time> </p> <div class="description"><p>Great overview of the labeling related requirements</p> </div> </div> </div> </li> <li class="review odd alt thread-odd thread-alt depth-1" id="li-comment-1864"> <div id="comment-1864" 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">Hologic </strong> <span class="woocommerce-review__dash">–</span> <time class="woocommerce-review__published-date" datetime="2022-09-30T13:14:31+00:00">September 30, 2022</time> </p> <div class="description"><p>The course provided me with a broader idea of what is involved in the subject of labels on medical equipment & devices. How important they are as a key point in the next step of the device manufacturing process when it gets into the hands of the healthcare professionals.</p> </div> </div> </div> </li> <li class="review even thread-even depth-1" id="li-comment-1751"> <div id="comment-1751" 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">Cantel </strong> <span class="woocommerce-review__dash">–</span> <time class="woocommerce-review__published-date" datetime="2022-10-04T15:45:23+00:00">October 4, 2022</time> </p> <div class="description"><p>I very much appreciated that the course deals with Labeling in a transversal way not only from Regulatory side but also from a broader point of view.</p> </div> </div> </div> </li> <li class="review odd alt thread-odd thread-alt depth-1" id="li-comment-1750"> <div id="comment-1750" 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">Holland & Barrett </strong> <span class="woocommerce-review__dash">–</span> <time class="woocommerce-review__published-date" datetime="2023-05-09T15:43:25+00:00">May 9, 2023</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 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