{"id":1937,"date":"2026-04-12T09:19:31","date_gmt":"2026-04-12T07:19:31","guid":{"rendered":"https:\/\/www.bayoocare.com\/?p=1937"},"modified":"2026-04-17T09:27:13","modified_gmt":"2026-04-17T07:27:13","slug":"when-is-a-product-a-medical-device-two-court-cases-bring-some-clarity","status":"publish","type":"post","link":"https:\/\/www.bayoocare.com\/en\/blog\/when-is-a-product-a-medical-device-two-court-cases-bring-some-clarity\/","title":{"rendered":"When is a product a medical device? Two court cases bring (some) clarity"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-right:0px;--awb-padding-left-small:0px;--awb-margin-top:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:0%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:0%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:0%;--awb-spacing-left-medium:0%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><p>Two recent proceedings from Germany highlight key questions of interpretation of the MDR that are crucial for many manufacturers. The Bochum Regional Court has referred the question to the European Court of Justice as to whether unprinted patient wristbands, which are intended to help prevent errors in everyday clinical practice, should be classified as medical devices even though they have no direct effect on or in the body. It is therefore a question of the significance of the intended purpose and whether a purely organizational benefit is sufficient for classification. An ECJ ruling is not expected until the end of 2025 at the earliest.   <\/p>\n<p>The ruling by the Hanseatic Higher Regional Court on a teledermatology app is even more far-reaching. Although the app itself does not make a diagnosis, but only transmits structured health data to specialists, it was classified as a medical device in risk class IIa. The court interprets Rule 11 of the MDR broadly: It is sufficient for software to contribute to the basis of medical decisions; an active diagnostic function is not necessary. This makes it clear that software no longer automatically falls into the lowest risk class.   <\/p>\n<p>Both cases show that MDR-relevant issues such as intended purpose and risk classification are increasingly being clarified in court &#8211; with major implications for approval obligations, competitive conditions and market opportunities. Manufacturers who invested in compliance at an early stage are increasingly finding themselves in a regulatory imbalance compared to less compliant competitors. Uniform and binding standards are therefore urgently required.  <\/p>\n<\/div><div class=\"fusion-text fusion-text-2\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 fusion-flex-container has-pattern-background has-mask-background nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:25px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_1 1_1 fusion-flex-column fusion-flex-align-self-stretch\" style=\"--awb-padding-top:50px;--awb-padding-right:50px;--awb-padding-bottom:50px;--awb-padding-left:50px;--awb-padding-top-small:35px;--awb-padding-right-small:30px;--awb-padding-bottom-small:35px;--awb-padding-left-small:30px;--awb-overflow:hidden;--awb-bg-color:var(--awb-color1);--awb-bg-color-hover:var(--awb-color1);--awb-bg-size:cover;--awb-box-shadow:0px 2px 7px 0px rgba(0,0,0,0.4);;--awb-border-radius:60px 60px 60px 60px;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:0%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:0%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:0%;--awb-spacing-left-medium:0%;--awb-width-small:100%;--awb-order-small:0;--awb-margin-top-small:40px;--awb-spacing-right-small:0%;--awb-spacing-left-small:0%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-center fusion-content-layout-column\"><div class=\"fusion-builder-row fusion-builder-row-inner fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"--awb-min-height:no;--awb-min-height-medium:no;--awb-min-height-small:no;--awb-flex-grow:0;--awb-flex-grow-medium:0;--awb-flex-grow-small:0;--awb-flex-shrink:0;--awb-flex-shrink-medium:0;--awb-flex-shrink-small:0;width:104% !important;max-width:104% !important;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-0 fusion_builder_column_inner_4_5 4_5 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:80%;--awb-margin-top-large:0px;--awb-spacing-right-large:2.4%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:3%;--awb-width-medium:80%;--awb-order-medium:0;--awb-spacing-right-medium:2.4%;--awb-spacing-left-medium:3%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-1 fusion-sep-none fusion-title-text fusion-title-size-three\" style=\"--awb-text-color:var(--awb-color8);--awb-margin-top-small:10px;--awb-margin-right-small:0px;--awb-margin-bottom-small:10px;--awb-margin-left-small:0px;\"><h3 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:30;line-height:var(--awb-typography1-line-height);\">Contact us<\/h3><\/div><div class=\"fusion-text fusion-text-3\" style=\"--awb-text-color:var(--awb-color4);\"><p>Are you planning to place a medical device on the market and looking for an experienced legal manufacturer? Contact us for a non-binding consultation. Together we will develop the right strategy for your medical device.  <\/p>\n<\/div><div ><a class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" style=\"--button-border-radius-top-left:60px;--button-border-radius-top-right:60px;--button-border-radius-bottom-right:60px;--button-border-radius-bottom-left:60px;\" target=\"_self\" href=\"#contact\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">Your contact to us<\/span><\/a><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column_inner fusion-builder-nested-column-1 fusion_builder_column_inner_1_5 1_5 fusion-flex-column fusion-flex-align-self-center fusion-no-small-visibility\" style=\"--awb-bg-size:cover;--awb-width-large:20%;--awb-margin-top-large:0px;--awb-spacing-right-large:9.6%;--awb-margin-bottom-large:20px;--awb-spacing-left-large:0%;--awb-width-medium:20%;--awb-order-medium:0;--awb-spacing-right-medium:9.6%;--awb-spacing-left-medium:0%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><i class=\"fb-icon-element-1 fb-icon-element fontawesome-icon fa-envelope fas circle-yes\" style=\"--awb-circlecolor:var(--awb-custom_color_3);--awb-circlecolor-hover:var(--awb-custom_color_3);--awb-circlebordercolor-hover:var(--awb-color8);--awb-circlebordersize:0px;--awb-font-size:57.2px;--awb-width:114.4px;--awb-height:114.4px;--awb-line-height:114.4px;--awb-margin-top:0;--awb-margin-right:0;--awb-margin-bottom:0;--awb-margin-left:32.5px;--awb-align-self:flex-end;\"><\/i><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Two current German proceedings highlight key MDR interpretation issues: intended purpose of products, risk classification of software and consequences for manufacturers.<\/p>\n","protected":false},"author":40,"featured_media":2266,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[31],"tags":[234,43],"class_list":["post-1937","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","tag-legal-proceedings","tag-medical-devices"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.6 (Yoast SEO v27.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>When is a product a medical device? 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