{"id":5716,"date":"2026-02-26T20:23:35","date_gmt":"2026-02-26T19:23:35","guid":{"rendered":"https:\/\/med-lab.ibv.org\/blog\/differences-between-mdr-and-mdd-for-manufacturers\/"},"modified":"2026-02-26T20:31:19","modified_gmt":"2026-02-26T19:31:19","slug":"differences-between-mdr-and-mdd-for-manufacturers","status":"publish","type":"post","link":"https:\/\/med-lab.ibv.org\/en\/blog\/differences-between-mdr-and-mdd-for-manufacturers\/","title":{"rendered":"Differences between MDR and MDD for manufacturers"},"content":{"rendered":"\n<p>The move from <strong>Directive 93\/42\/EEC (MDD)<\/strong> to <strong>Regulation (EU) 2017\/745 (MDR)<\/strong> has brought about one of the biggest regulatory changes in the history of the <strong>medical device<\/strong> sector in Europe.<\/p>\n\n<p>For manufacturers, the transition has not simply been a regulatory change, but a profound transformation in:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>technical documentation requirements,<\/li>\n\n\n\n<li>testing and validation requirements,<\/li>\n\n\n\n<li>clinical evaluation,<\/li>\n\n\n\n<li>post-marketing surveillance,<\/li>\n\n\n\n<li>and relationship with notified bodies.<\/li>\n<\/ul>\n\n<p>In this article we answer the most frequently asked questions about the differences between MDR and MDD and explain how they directly affect the development and certification of medical devices.<\/p>\n\n<h2 class=\"wp-block-heading\">What changes conceptually between MDD and MDR?<\/h2>\n\n<p>The <strong>MDD<\/strong> was a directive, which meant that each Member State transposed it into its national legislation. The <strong>MDR<\/strong>, on the other hand, is a regulation that is directly applicable in all European Union countries. <\/p>\n\n<p>This involves:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>greater regulatory harmonization,<\/li>\n\n\n\n<li>less room for national interpretation,<\/li>\n\n\n\n<li>more stringent and homogeneous criteria.<\/li>\n<\/ul>\n\n<p>The MDR introduces a much more focused approach to <strong>patient safety, traceability and continuous clinical evidence<\/strong>.<\/p>\n\n<h2 class=\"wp-block-heading\">Main technical differences between MDD and MDR<\/h2>\n\n<h3 class=\"wp-block-heading\">1\ufe0f\u20e3 More demanding in clinical evaluation<\/h3>\n\n<p>Under MDD, it was more common to rely on equivalences with products already on the market.<br\/>With the MDR:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>further clinical justification is required,<\/li>\n\n\n\n<li>access to equivalence data is more limited,<\/li>\n\n\n\n<li>the need for in-house testing is increasing.<\/li>\n<\/ul>\n\n<p>This directly affects manufacturers of implantable products, where clinical evidence is critical.<\/p>\n\n<h3 class=\"wp-block-heading\">2\ufe0f\u20e3 Strengthening testing and technical validation<\/h3>\n\n<p>The MDR requires the manufacturer to demonstrate:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>mechanical performance,<\/li>\n\n\n\n<li>structural safety,<\/li>\n\n\n\n<li>biocompatibility,<\/li>\n\n\n\n<li>long-term stability.<\/li>\n<\/ul>\n\n<p>Tests must be well documented and, in many cases, performed in <strong>ISO\/IEC 17025 accredited laboratories<\/strong> to facilitate acceptance by notified bodies.<\/p>\n<figure style=\"height:600px;\" class=\"wp-block-post-featured-image\"><img fetchpriority=\"high\" decoding=\"async\" width=\"500\" height=\"500\" src=\"https:\/\/med-lab.ibv.org\/wp-content\/uploads\/2026\/02\/diferencias-mdr-mdd.png\" class=\"attachment-post-thumbnail size-post-thumbnail wp-post-image\" alt=\"differences-mdr-mdd\" style=\"height:600px;object-fit:contain;\" srcset=\"https:\/\/med-lab.ibv.org\/wp-content\/uploads\/2026\/02\/diferencias-mdr-mdd.png 500w, https:\/\/med-lab.ibv.org\/wp-content\/uploads\/2026\/02\/diferencias-mdr-mdd-300x300.png 300w, https:\/\/med-lab.ibv.org\/wp-content\/uploads\/2026\/02\/diferencias-mdr-mdd-150x150.png 150w\" sizes=\"(max-width: 500px) 100vw, 500px\" \/><\/figure>\n<h3 class=\"wp-block-heading\">3\ufe0f\u20e3 Reclassification of medical devices<\/h3>\n\n<p>Some products that under MDD were class I or IIa have been reclassified into higher classes under MDR, especially:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>implantable products,<\/li>\n\n\n\n<li>products that interact with the central nervous system,<\/li>\n\n\n\n<li>certain reusable products.<\/li>\n<\/ul>\n\n<p>This reclassification implies more rigorous assessments and greater involvement of the notified body.<\/p>\n\n<h3 class=\"wp-block-heading\">4\ufe0f\u20e3 Increased post-marketing control<\/h3>\n\n<p>The MDR introduces enhanced requirements for:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>post-marketing clinical follow-up (PMCF),<\/li>\n\n\n\n<li>active surveillance,<\/li>\n\n\n\n<li>continuous risk analysis,<\/li>\n\n\n\n<li>updating of the technical file.<\/li>\n<\/ul>\n\n<p>The manufacturer can no longer consider certification as an end point, but as a continuous process.<\/p>\n\n<h2 class=\"wp-block-heading\">Real impact for manufacturers<\/h2>\n\n<p>The change from MDD to MDR has meant:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>increase in certification costs,<\/li>\n\n\n\n<li>longer preparation time of the technical dossier,<\/li>\n\n\n\n<li>need for additional testing,<\/li>\n\n\n\n<li>strategic planning earlier in the development of the medical device.<\/li>\n<\/ul>\n\n<p>Manufacturers that integrate MDR requirements upstream reduce the risk of delays and retesting.<\/p>\n\n<h2 class=\"wp-block-heading\">Role of accredited trials under MDR<\/h2>\n\n<p>Although the MDR does not explicitly mandate that all trials be accredited, in practice:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>notified bodies prioritize accredited tests,<\/li>\n\n\n\n<li>implantable products require particularly strong evidence,<\/li>\n\n\n\n<li>traceability and technical competence of the laboratory become more important.<\/li>\n<\/ul>\n\n<p>Working with an accredited laboratory reduces observations and speeds up the CE marking process.<\/p>\n\n<h2 class=\"wp-block-heading\">How Med-Lab IBV supports the MDR Transition<\/h2>\n\n<p>Med-Lab IBV accompanies manufacturers in:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>strategic trial planning under MDR,<\/li>\n\n\n\n<li>adaptation of technical documentation,<\/li>\n\n\n\n<li>execution of accredited mechanical and biomechanical tests,<\/li>\n\n\n\n<li>certification-oriented technical interpretation.<\/li>\n<\/ul>\n\n<p>This approach makes it possible to transform regulatory compliance into a <strong>competitive advantage<\/strong>, rather than an obstacle.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The move from Directive 93\/42\/EEC (MDD) to Regulation (EU) 2017\/745 (MDR) has brought about one of the biggest regulatory changes in the history of the medical device sector in Europe. For manufacturers, the transition has not simply been a regulatory change, but a profound transformation in: In this article we answer the most frequently asked [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":5717,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[55],"tags":[],"class_list":["post-5716","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-resources"],"_links":{"self":[{"href":"https:\/\/med-lab.ibv.org\/en\/wp-json\/wp\/v2\/posts\/5716","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/med-lab.ibv.org\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/med-lab.ibv.org\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/med-lab.ibv.org\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/med-lab.ibv.org\/en\/wp-json\/wp\/v2\/comments?post=5716"}],"version-history":[{"count":2,"href":"https:\/\/med-lab.ibv.org\/en\/wp-json\/wp\/v2\/posts\/5716\/revisions"}],"predecessor-version":[{"id":5727,"href":"https:\/\/med-lab.ibv.org\/en\/wp-json\/wp\/v2\/posts\/5716\/revisions\/5727"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/med-lab.ibv.org\/en\/wp-json\/wp\/v2\/media\/5717"}],"wp:attachment":[{"href":"https:\/\/med-lab.ibv.org\/en\/wp-json\/wp\/v2\/media?parent=5716"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/med-lab.ibv.org\/en\/wp-json\/wp\/v2\/categories?post=5716"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/med-lab.ibv.org\/en\/wp-json\/wp\/v2\/tags?post=5716"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}