{"id":375,"date":"2026-08-11T10:08:11","date_gmt":"2026-08-11T08:08:11","guid":{"rendered":"https:\/\/www.pqra.gr\/medical-device-classification-under-the-mdr\/"},"modified":"2026-08-27T11:40:50","modified_gmt":"2026-08-27T09:40:50","slug":"medical-device-classification-under-the-mdr","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/medical-device-classification-under-the-mdr\/","title":{"rendered":"Medical Device Classification Under the MDR"},"content":{"rendered":"<p style=\"font-size:19px;line-height:1.7;color:#33414d;\"><strong>Under the EU Medical Device Regulation, everything starts with classification. Get the risk class right and the whole route to market follows logically; get it wrong and you build your entire compliance strategy on the wrong foundation.<\/strong><\/p>\n<p>The MDR (Regulation (EU) 2017\/745) sorts devices into four risk classes &mdash; <strong>Class I<\/strong> (lowest risk), <strong>IIa<\/strong>, <strong>IIb<\/strong> and <strong>III<\/strong> (highest). Class I has three sub-categories: Is (sterile), Im (measuring function) and Ir (reusable surgical instruments).<\/p>\n<h2>Rule-based, and driven by intended purpose<\/h2>\n<p>Classification is not a matter of opinion &mdash; it follows the <strong>22 rules of Annex VIII<\/strong>, grouped into non-invasive devices (Rules 1&ndash;4), invasive devices (Rules 5&ndash;8), active devices (Rules 9&ndash;13) and special rules (Rules 14&ndash;22). The determining factor is the device&#8217;s <strong>intended purpose<\/strong>, together with duration of contact, degree of invasiveness and whether the device is active. Where several rules apply, the highest resulting class governs.<\/p>\n<h2>The up-classification effect<\/h2>\n<p>Compared with the old Medical Device Directive, the MDR pushed many products into higher classes. Reusable surgical instruments now need notified body involvement for the reusable aspect, and a range of substance-based and software products moved up. Manufacturers who assumed their legacy classification still held have often been caught out.<\/p>\n<h2>Rule 11: the software trap<\/h2>\n<p>Software is the single biggest driver of up-classification. Under Rule 11, software that provides information used for diagnostic or therapeutic decisions is <strong>Class IIa<\/strong> &mdash; rising to <strong>IIb<\/strong> where a wrong decision could cause serious deterioration of health or surgical intervention, and <strong>Class III<\/strong> where it could cause death or irreversible deterioration. Much software that self-certified under the old rules now needs a notified body.<\/p>\n<h2>Class decides the route<\/h2>\n<p>Only Class I (non-sterile, non-measuring, non-reusable-surgical) is self-declared with no notified body. Every higher class &mdash; including Is, Im and Ir &mdash; requires notified body involvement. Classification is therefore the decision that determines cost, timeline and evidence burden for everything that follows.<\/p>\n<h2>How PQRA helps<\/h2>\n<p>PQRA advises on device classification, intended-purpose definition and the conformity-assessment route best suited to your product.<\/p>\n<p><strong><a href=\"\/el\/contact\/\">Talk to us about your device &rarr;<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>Under the EU Medical Device Regulation, everything starts with classification. Get the risk class right and the whole route to market follows logically; get it wrong and you build your entire compliance strategy on the wrong foundation. The MDR (Regulation (EU) 2017\/745) sorts devices into four risk classes &mdash; Class I (lowest risk), IIa, IIb [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":383,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"saved_in_kubio":false,"_swpsp_post_exclude":false,"footnotes":""},"categories":[9,14],"tags":[],"class_list":["post-375","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-knowledge-base","category-medical-devices"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Medical Device Classification Under the MDR - PQRA<\/title>\n<meta name=\"description\" content=\"Under the EU Medical Device Regulation, everything starts with classification. 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