{"id":6823,"date":"2026-06-09T10:32:45","date_gmt":"2026-06-09T05:02:45","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=6823"},"modified":"2026-06-09T10:32:45","modified_gmt":"2026-06-09T05:02:45","slug":"eu-mdr-faq","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/sa-en\/eu-mdr-faq\/","title":{"rendered":"EU MDR FAQs: All you need to know (European MDR)"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6823\" class=\"elementor elementor-6823\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f3b1ff5 e-flex e-con-boxed e-con e-parent\" data-id=\"f3b1ff5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-4dc86615 e-con-full e-flex e-con e-child\" data-id=\"4dc86615\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6e6ce6cc elementor-widget elementor-widget-heading\" data-id=\"6e6ce6cc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">EU MDR FAQs: All you need to know (European MDR)<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-54cc3137 e-flex e-con-boxed e-con e-parent\" data-id=\"54cc3137\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-363b765 e-con-full e-flex e-con e-child\" data-id=\"363b765\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-206ad4b6 elementor-widget elementor-widget-heading\" data-id=\"206ad4b6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What is EU MDR?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-32e06211 elementor-widget elementor-widget-text-editor\" data-id=\"32e06211\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The EU MDR, or <\/span><a href=\"https:\/\/operonstrategist.com\/eu-medical-device-regulation\/\"><span style=\"font-weight: 400;\">European Medical Device Regulation<\/span><\/a><span style=\"font-weight: 400;\">, governs the manufacturing and distribution of medical devices in Europe. EU MDR Compliance is mandatory for companies selling in this market. Even if compliant with the older MDD, the MDR introduces significant changes, requiring a proactive approach.<\/span><\/p><p><span style=\"font-weight: 400;\">To assist medical device companies, we\u2019ve compiled an article answering nine key questions about the new MDR. It delves into reasons for the update, the structure of the new MDR document, and essential requirements for manufacturers and industry players.<\/span><\/p><p><span style=\"font-weight: 400;\">This regulation establishes a comprehensive framework for medical device manufacturing and distribution in Europe. The accompanying FAQ aims to clarify uncertainties, aiding compliance and understanding in the industry.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-102201e8 e-con-full e-flex e-con e-child\" data-id=\"102201e8\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-263b76df e-con-full e-flex e-con e-child\" data-id=\"263b76df\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-722fb722 elementor-widget elementor-widget-heading\" data-id=\"722fb722\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Looking for EU MDR Consultant?\n<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3a4498e6 elementor-widget elementor-widget-wpforms\" data-id=\"3a4498e6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"wpforms-container wpforms-container-full wpforms-render-modern\" id=\"wpforms-6203\"><form id=\"wpforms-form-6203\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"6203\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/sa-en\/wp-json\/wp\/v2\/posts\/6823\" data-token=\"08115cc9be9ad5588cc368d2a2d40326\" data-token-time=\"1781392246\"><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div id=\"wpforms-error-noscript\" style=\"display: none;\">Please enable JavaScript in your browser to complete this form.<\/div><div class=\"wpforms-field-container\">\t\t<div id=\"wpforms-6203-field_5-container\"\n\t\t\tclass=\"wpforms-field wpforms-field-text\"\n\t\t\tdata-field-type=\"text\"\n\t\t\tdata-field-id=\"5\"\n\t\t\t>\n\t\t\t<label class=\"wpforms-field-label\" for=\"wpforms-6203-field_5\" >Phone Text Email<\/label>\n\t\t\t<input type=\"text\" id=\"wpforms-6203-field_5\" class=\"wpforms-field-medium\" name=\"wpforms[fields][5]\" >\n\t\t<\/div>\n\t\t<div id=\"wpforms-6203-field_1-container\" class=\"wpforms-field wpforms-field-name\" data-field-id=\"1\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_1\" aria-hidden=\"false\">Name <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"text\" id=\"wpforms-6203-field_1\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][1]\" placeholder=\"Name*\" aria-errormessage=\"wpforms-6203-field_1-error\" required><\/div><div id=\"wpforms-6203-field_2-container\" class=\"wpforms-field wpforms-field-email\" data-field-id=\"2\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_2\" aria-hidden=\"false\">Email <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"email\" id=\"wpforms-6203-field_2\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][2]\" placeholder=\"Email*\" spellcheck=\"false\" aria-errormessage=\"wpforms-6203-field_2-error\" required><\/div><div id=\"wpforms-6203-field_3-container\" class=\"wpforms-field wpforms-field-phone\" data-field-id=\"3\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_3\" aria-hidden=\"false\">Phone <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"tel\" id=\"wpforms-6203-field_3\" class=\"wpforms-field-large wpforms-field-required wpforms-smart-phone-field\" data-rule-smart-phone-field=\"true\" name=\"wpforms[fields][3]\" placeholder=\"Phone*\" aria-label=\"Phone\" aria-errormessage=\"wpforms-6203-field_3-error\" required><\/div><div id=\"wpforms-6203-field_4-container\" class=\"wpforms-field wpforms-field-textarea\" data-field-id=\"4\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_4\" aria-hidden=\"false\">Paragraph Text <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><textarea id=\"wpforms-6203-field_4\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][4]\" placeholder=\"Message\" aria-errormessage=\"wpforms-6203-field_4-error\" required><\/textarea><\/div><script>\n\t\t\t\t( function() {\n\t\t\t\t\tconst style = document.createElement( 'style' );\n\t\t\t\t\tstyle.appendChild( document.createTextNode( '#wpforms-6203-field_5-container { position: absolute !important; overflow: hidden !important; display: inline !important; height: 1px !important; width: 1px !important; z-index: -1000 !important; padding: 0 !important; } #wpforms-6203-field_5-container input { visibility: hidden; } #wpforms-conversational-form-page #wpforms-6203-field_5-container label { counter-increment: none; }' ) );\n\t\t\t\t\tdocument.head.appendChild( style );\n\t\t\t\t\tdocument.currentScript?.remove();\n\t\t\t\t} )();\n\t\t\t<\/script><\/div><!-- .wpforms-field-container --><div class=\"wpforms-recaptcha-container wpforms-is-recaptcha wpforms-is-recaptcha-type-v3\" ><input type=\"hidden\" name=\"wpforms[recaptcha]\" value=\"\"><\/div><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"6203\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/posts\/6823\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-6203\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"Submit\" aria-live=\"assertive\" value=\"wpforms-submit\">Submit<\/button><img decoding=\"async\" src=\"https:\/\/operonstrategist.com\/wp-content\/plugins\/wpforms\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Loading\"><\/div><\/form><\/div>  <!-- .wpforms-container -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-7bebf75c e-flex e-con-boxed e-con e-parent\" data-id=\"7bebf75c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7e99041a elementor-widget elementor-widget-heading\" data-id=\"7e99041a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">1. Why Did the MDD Need an Update?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5d119f38 elementor-widget elementor-widget-text-editor\" data-id=\"5d119f38\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">There were many reasons the MDD needed to be updated. For instance, when the MDD came into law in 1992, software as a medical device (SaMD) did not yet exist. Software was something that controlled electric machines, and there were no apps that patients could use to monitor their own health. Demographics have also changed in Europe since 1992, with the population growing older, and there is a growing push for transparency of medical device technical information to the general public. These factors combined are the some of the reasons that the MDD is being replaced with a new directive that will encourage wider compliance with standardized medical device regulations throughout Europe.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8c34dbd elementor-widget elementor-widget-heading\" data-id=\"8c34dbd\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">2. How is the New EU MDR Structured?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-12b06ba elementor-widget elementor-widget-text-editor\" data-id=\"12b06ba\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The new MDR document is 174 pages in length. It contains a 13-page introduction, followed by 123 articles in 10 chapters (79 pages), and 17 annexes (80 pages). Compared with the MDD, which was 60 pages in length, the new regulations are much longer and more detailed. In addition to that, there have been published 42 implementing acts, which are used to clarify\/implement the MDR and 12 delegating acts, used to modify\/amend it.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a3420de elementor-widget elementor-widget-heading\" data-id=\"a3420de\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">3. What Are the Major Thematic Changes in the EU Medical Device Regulation?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e921eae elementor-widget elementor-widget-text-editor\" data-id=\"e921eae\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Compared with its predecessor, the MDD, the new European MDR is less focused on the pre-approval stage of medical device manufacturing, and instead, promotes a life-cycle approach to medical device regulation. While the old MDD essentially served as a manual for how medical device companies could get their CE marking and get to market, the new regulations encourage policies and procedures that elevate the responsibilities of medical device companies for their products throughout the product lifecycle.<\/span><\/p><p><span style=\"font-weight: 400;\">The European market comprises 27 member states (not including the United Kingdom) along with others that fall into the European Economic Area (Liechtenstein, Norway, Iceland). The region is inhabited by an aging population of 500 million people, and as populations age, they face greater risks associated with medical device malfunctions and adverse events. This is one of the main reasons that the regulations focus on product life-cycle, not just getting to market.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6093311 elementor-widget elementor-widget-heading\" data-id=\"6093311\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">4. What Devices Are Covered Under the EU MDR?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0667b3b elementor-widget elementor-widget-text-editor\" data-id=\"0667b3b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The EU Medical Device Regulation (EU MDR) defines the term \u201cmedical device\u201d as an \u201cinstrument, apparatus, appliance, software, implant, reagent, material, or other article\u201d that is used for any of the following:<\/span><\/p><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Diagnosis, prevention, monitoring, treatment or alleviation of disease, disability, or injury, but not for disability or injury prevention<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Investigation, replacement, or modification of an anatomical, physiological, or pathological process<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Providing data via in-vitro examination of samples derived from a human body<\/span><\/li><\/ul><p><span style=\"font-weight: 400;\">This definition covers a broad range of existing devices, but that\u2019s not all. The MDR newly specifies certain types of products that need to obtain a <a href=\"https:\/\/operonstrategist.com\/elevateplus\/ce-marking-eu-mdr-ivdr\/\">CE marking<\/a>, including products used to clean, disinfect, or sterilize medical devices, and devices used to control and support conception, whether through pharmacological, immunological, or metabolic means.<\/span><\/p><p><span style=\"font-weight: 400;\">It is important to consult the regulations directly to determine whether your medical device is covered under the MDR. Even so, you may be spared some of the hardships of compliance depending on your <a href=\"https:\/\/operonstrategist.com\/examples-of-medical-device-classifications\/\">device classification<\/a>. Under the MDR, Class I devices are exempt from being required to have their QMS audited by a third-party auditor (notified body).<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6e128e6 elementor-widget elementor-widget-heading\" data-id=\"6e128e6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">5. What Devices are Covered Under Annex XVI of the MDR?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7cc666b elementor-widget elementor-widget-text-editor\" data-id=\"7cc666b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Annex XVI of the Medical Device Regulation (MDR) encompasses various devices that were not previously considered medical devices but now fall under the regulatory framework. This section expands the scope of products subject to compliance regulations, affecting companies that hadn\u2019t been under such regulations before.<\/span><\/p><p><span style=\"font-weight: 400;\">Under Annex XVI of the MDR, the following categories of products are required to comply with MDR requirements:<\/span><\/p><ol><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Products for use in or on the eye (e.g., contact lenses, eye drops, cosmetic contact lenses)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Devices introduced into the body via invasive procedures to alter anatomy (e.g., silicone breast implants)<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Substances and products used for facial or subcutaneous fillings<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Equipment utilized in liposuction, lipolysis, or lipoplasty procedures<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">High-intensity radiation equipment for tattoo and hair removal<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Devices using electrical or magnetic currents to stimulate the brain<\/span><\/li><\/ol><p><span style=\"font-weight: 400;\">Annex XVI addresses the gaps present in the previous Medical Device Directive (MDD), extending regulation to devices used in procedures that were previously exempt due to their cosmetic rather than medical nature.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-925023d elementor-widget elementor-widget-heading\" data-id=\"925023d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">6. Is Enhanced Device Traceability and Technical Documentation Required by the EU MDR?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3ad180c elementor-widget elementor-widget-text-editor\" data-id=\"3ad180c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The EU\u2019s Medical Device Regulation (MDR) mandates better device traceability through <\/span><a href=\"https:\/\/operonstrategist.com\/unique-device-identification-udi-system\/\"><span style=\"font-weight: 400;\">Unique Device Identification<\/span><\/a><span style=\"font-weight: 400;\"> (UDI) for all medical devices in the region. It requires a device identifier (DI) for individual device identification and a production identifier (PI) for batch traceability. Additionally, it introduces databases like EUDAMED, enabling access to updated information on devices for clinical investigations, registration, and post-market surveillance by stakeholders.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9719c17 elementor-widget elementor-widget-heading\" data-id=\"9719c17\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">7. How Will the MDR Affect CE Markings?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c3629f2 elementor-widget elementor-widget-text-editor\" data-id=\"c3629f2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The MDR introduces crucial changes for obtaining and keeping the CE marking for medical devices:<\/span><\/p><ol><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Device classification now depends on intended use rather than previous methods.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">A designated Person Responsible for Compliance (PRRC) is mandatory under Article 15 of the MDR.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Manufacturers outside the EU must appoint an Authorized Representative within the region.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The review process by Notified Bodies is more rigorous, involving three rounds of scrutiny.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Despite a five-year CE marking validity, ongoing audits, documentation upkeep, and post-market surveillance are mandatory for compliance.<\/span><\/li><\/ol>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8bd682d elementor-widget elementor-widget-heading\" data-id=\"8bd682d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">8. How is clinical evaluation impacted by the EU MDR?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bd8974a elementor-widget elementor-widget-text-editor\" data-id=\"bd8974a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The EU MDR brings significant changes to clinical evaluation requirements for obtaining a CE marking:<\/span><\/p><ol><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Clinical Evaluation Reports (CERs) are now mandatory and must be included in the CE technical file, providing crucial safety and performance data.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Reclassification may affect certain in vitro diagnostic devices, potentially moving them from a \u201cGeneral\u201d classification to \u201cAnnex II List A,\u201d requiring additional scrutiny from notified bodies.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The scrutiny process involves potential reevaluation of technical documentation for high-risk devices, potentially impacting approval timelines.<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Comparative evaluations under the MDR demand more extensive data analysis to demonstrate product safety and performance, necessitating the collection and analysis of a larger volume of data.<\/span><\/li><\/ol>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0be0262 elementor-widget elementor-widget-heading\" data-id=\"0be0262\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">9. How does the new MDR affect my QMS?\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1454362 elementor-widget elementor-widget-text-editor\" data-id=\"1454362\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Once the new MDR goes into effect in May of 2020, any and all previous \u201cdirectives\u201d will no longer exist or be applicable to quality systems. Instead, they will have a new name and carry a much more substantial meaning \u2014 Regulations. Simple translation is that these changes are now going to be considered laws\u2014similar to FDA medical device regulations.<\/span><\/p><p><span style=\"font-weight: 400;\">Manufacturers shall follow what is now known as \u201cGeneral Obligations\u201d to ensure compliance for their <\/span><a href=\"https:\/\/operonstrategist.com\/elevateplus\/quality-management-system-qms\/\"><span style=\"font-weight: 400;\">quality management systems<\/span><\/a><span style=\"font-weight: 400;\"> (QMS). This comprehensive list can be found in the new MDR starting from Article X. As stated in the MDR guidance, manufacturers shall establish, document and implement a quality system, and maintain its effectiveness throughout the entire device lifecycle. There\u2019s also a strong emphasis placed on the management functionality of that QMS for required procedures with document storage, post-market surveillance, and risk assessments of new and existing devices.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>What is EU MDR? The EU MDR, or European Medical Device Regulation, governs the manufacturing and distribution of medical devices in Europe. EU MDR Compliance is mandatory for companies selling in this market. Even if compliant with the older MDD, the MDR introduces significant changes, requiring a proactive approach. To assist medical device companies, we\u2019ve [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":10832,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[55],"tags":[],"class_list":["post-6823","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulatory"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/posts\/6823","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/comments?post=6823"}],"version-history":[{"count":5,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/posts\/6823\/revisions"}],"predecessor-version":[{"id":10841,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/posts\/6823\/revisions\/10841"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/media\/10832"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/media?parent=6823"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/categories?post=6823"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/sa-en\/wp-json\/wp\/v2\/tags?post=6823"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}