{"id":35580,"date":"2026-04-28T12:53:49","date_gmt":"2026-04-28T10:53:49","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=35580"},"modified":"2026-04-29T09:20:47","modified_gmt":"2026-04-29T07:20:47","slug":"mdcg-2021-24-rev-1-interpretative-updates-on-medical-device-classification","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2026\/04\/28\/mdcg-2021-24-rev-1-interpretative-updates-on-medical-device-classification\/","title":{"rendered":"MDCG 2021-24 Rev.1: Interpretative Updates on Medical Device Classification"},"content":{"rendered":"<p style=\"text-align: right;\"><em>Translated with AI<\/em><\/p>\n<p>On April 20, 2026, <strong>Revision 1 of the MDCG 2021-24 guidance<\/strong> was published. This update introduces significant interpretative clarifications for the <strong>classification of medical devices under the MDR (EU) 2017\/745 framework<\/strong>, with a particular focus on implantable devices, defibrillator accessories, active devices, and sterilizers. The goal is to promote a more uniform interpretation of the MDR by manufacturers and Notified Bodies.<\/p>\n<h3><strong>From Surgical Procedure to Clinical Procedure<\/strong><\/h3>\n<p>The <strong>term \u201csurgical\u201d has been replaced with \u201cclinical.\u201d<\/strong> The guidance clarifies that the notion of <strong>clinical procedure<\/strong> includes <strong>both surgical and non-surgical interventions<\/strong>. In this context:<\/p>\n<ul>\n<li>Devices introduced via non-surgical techniques, such as <strong>cannulas, catheters, or needles<\/strong>, fall under the concept of an implant.<\/li>\n<li>The <strong>30-day criterion provided by the MDR<\/strong> remains decisive: a device introduced partially or totally for at least 30 days within a clinical procedure is considered <strong>implantable<\/strong>, even in the absence of a traditional incision.<\/li>\n<\/ul>\n<p>In summary, the qualification as an &#8220;<strong>implantable device<\/strong>&#8221; cannot be excluded solely because the device is not introduced through a traditional surgical procedure.<\/p>\n<h3><strong>Rule 8 and New Clarifications<\/strong><\/h3>\n<p>Rule 8 of Annex VIII of MDR (EU) 2017\/745 governs <strong>implantable<\/strong> and <strong>long-term invasive devices<\/strong>. Generally, these devices are classified as <strong>Class IIb<\/strong> but may fall into <strong>Class III<\/strong> when intended for contact with the heart, the central nervous system, or the central circulatory system.<\/p>\n<p>Revision 1 <strong>increases the practical notes for Rule 8<\/strong> <strong>from five to seven<\/strong>, introducing key operational clarifications:<\/p>\n<ul>\n<li>The <strong>exemption provided by Article 52, paragraph 4<\/strong> <strong>of the MDR<\/strong>, for certain Class IIb devices (such as sutures, staples, screws, plates, etc.) concerns the conformity assessment path and does not determine the device&#8217;s class.<\/li>\n<li>Classification remains anchored to the applicable <strong>rules of Annex VIII<\/strong> and the product\u2019s intended purpose.<\/li>\n<li>The concept of <strong>contact with the spine<\/strong> <strong>is extended to all the bony structures that make it up,<\/strong> from the cervical region to the coccyx, including the spinous and transverse processes. This clarification is also relevant for <strong>spinal hooks<\/strong> and similar devices, as it supports a broad anatomical interpretation of Rule 8, consistent with the logic of the rule and with the exceptions already provided for certain categories of implantable devices.<\/li>\n<\/ul>\n<h3><strong>Rule 10 and Active Devices<\/strong><\/h3>\n<p>Revision 1 updates the section on <strong>active devices<\/strong> with <strong>new examples in Rule 10<\/strong> and a reorganized text to clarify the relationship between device function and classification. Notably:<\/p>\n<ul>\n<li>Updated examples include <strong>ophthalmoscopes<\/strong>, which the guidance categorizes as active devices with a specific diagnostic or observation function.<\/li>\n<li>The focus is on making the application criteria of the rule more readable in relation to the product&#8217;s intended purpose.<\/li>\n<\/ul>\n<h3><strong>Rule 16 and Sterilizers<\/strong><\/h3>\n<p>Another clarification concerns Rule 16, which in Revision 1 confirms <strong>the classification in Class IIa for sterilizers intended to sterilize medical devices in a medical environment<\/strong>, whether invasive or non-invasive. In particolar:<\/p>\n<ul>\n<li>Class IIa continues to apply to sterilizers used in a medical environment.<\/li>\n<li>Clarification serves to better delimit the scope of the rule.<\/li>\n<li>The aim is to reduce interpretative uncertainty in the classification of sterilizers used in healthcare facilities or similar settings.<\/li>\n<\/ul>\n<h3><strong>Other Technical Updates<\/strong><\/h3>\n<ul>\n<li><strong>Defibrillator Accessories (Rule 22):<\/strong> distinction between accessories integrated into the system and those placed separately on the market, which may fall under Rule 9 or Rule 1.<\/li>\n<li><strong>Active Devices:<\/strong> new application examples for Rule 10 and updates for Rule 12.<\/li>\n<li><strong>Terminology (Section 3.2):<\/strong> systematic replacement of the term \u201cdevice\u201d with \u201cproduct\u201d for alignment with Regulation (EU) 2017\/745.<\/li>\n<\/ul>\n<h3><strong>Conclusions<\/strong><\/h3>\n<p>MDCG 2021-24 Revision 1 is a pivotal update for the medical device sector. Manufacturers must reassess their device classifications in light of these changes, verifying the impact on technical documentation and conformity assessment procedures.<\/p>\n<p><strong>&gt;&gt;&gt; Complife<\/strong> supports medical device manufacturers with strategic-regulatory consultancy, from the correct classification of medical devices to compliance throughout the entire product lifecycle.<\/p>\n<p>SOURCE:<br \/>\n<a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/update-mdcg-2021-24-rev1-guidance-classification-medical-devices-april-2026-2026-04-20_en\">https:\/\/health.ec.europa.eu\/latest-updates\/update-mdcg-2021-24-rev1-guidance-classification-medical-devices-april-2026-2026-04-20_en<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Translated with AI On April 20, 2026, Revision 1 of the MDCG 2021-24 guidance was published. This update introduces significant interpretative  [&#8230;]<\/p>\n","protected":false},"author":115,"featured_media":35591,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-35580","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>MDCG 2021-24 Rev.1: Interpretative Updates on Medical Device Classification - Thema Med<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.thema-med.com\/en\/2026\/04\/28\/mdcg-2021-24-rev-1-interpretative-updates-on-medical-device-classification\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MDCG 2021-24 Rev.1: Interpretative Updates on Medical Device Classification - Thema Med\" \/>\n<meta property=\"og:description\" content=\"Translated with AI On April 20, 2026, Revision 1 of the MDCG 2021-24 guidance was published. 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