{"id":73941,"date":"2026-07-02T06:21:32","date_gmt":"2026-07-02T06:21:32","guid":{"rendered":"https:\/\/rocket.dental\/?page_id=73941"},"modified":"2026-08-14T11:44:08","modified_gmt":"2026-08-14T11:44:08","slug":"safety-reporting","status":"publish","type":"page","link":"https:\/\/rocket.dental\/en\/safety-reporting\/","title":{"rendered":"Safety Reporting &#8211; Vigilance"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"73941\" class=\"elementor elementor-73941 elementor-73423\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-52c73dc e-con e-atomic-element e-flexbox-base e-52c73dc-8f9125f \" data-id=\"52c73dc\" data-element_type=\"e-flexbox\" data-e-type=\"e-flexbox\" data-interaction-id=\"52c73dc\" data-e-type=\"e-flexbox\" data-id=\"52c73dc\">\n    \t\t<div class=\"elementor-element elementor-element-a73f882 elementor-widget elementor-widget-heading\" data-id=\"a73f882\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Safety Reporting - Vigilance<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\n<\/div>\n<div class=\"elementor-element elementor-element-3f5127a e-con e-atomic-element e-flexbox-base e-3f5127a-b96431d \" data-id=\"3f5127a\" data-element_type=\"e-flexbox\" data-e-type=\"e-flexbox\" data-interaction-id=\"3f5127a\" data-e-type=\"e-flexbox\" data-id=\"3f5127a\">\n    <div class=\"elementor-element elementor-element-be73817 e-con e-atomic-element e-flexbox-base e-be73817-66f20a7 \" data-id=\"be73817\" data-element_type=\"e-flexbox\" data-e-type=\"e-flexbox\" data-interaction-id=\"be73817\" data-e-type=\"e-flexbox\" data-id=\"be73817\">\n    <div class=\"elementor-element elementor-element-9d8e67c e-con e-atomic-element e-flexbox-base e-9d8e67c-c0a2cab \" data-id=\"9d8e67c\" data-element_type=\"e-flexbox\" data-e-type=\"e-flexbox\" data-interaction-id=\"9d8e67c\" data-e-type=\"e-flexbox\" data-id=\"9d8e67c\">\n    \t\t<div class=\"elementor-element elementor-element-bb640c3 elementor-widget-tablet__width-inherit elementor-widget elementor-widget-shortcode\" data-id=\"bb640c3\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;sticky&quot;:&quot;top&quot;,&quot;sticky_offset&quot;:70,&quot;sticky_parent&quot;:&quot;yes&quot;,&quot;sticky_on&quot;:[&quot;desktop&quot;,&quot;tablet&quot;,&quot;mobile&quot;],&quot;sticky_effects_offset&quot;:0,&quot;sticky_anchor_link_offset&quot;:0}\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-shortcode\">    <nav id=\"custom-toc\">\n        <ol id=\"custom-toc-list\"><\/ol>\n    <\/nav>\n    <\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\n<\/div>\n<div class=\"elementor-element elementor-element-ae8a4d2 e-con e-atomic-element e-flexbox-base e-ae8a4d2-9e0c139 \" data-id=\"ae8a4d2\" data-element_type=\"e-flexbox\" data-e-type=\"e-flexbox\" data-interaction-id=\"ae8a4d2\" data-e-type=\"e-flexbox\" data-id=\"ae8a4d2\">\n    \t\t<div class=\"elementor-element elementor-element-9b7cf33 titleLegacy elementor-widget elementor-widget-heading\" data-id=\"9b7cf33\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><span>1.<\/span> Reporting Serious Incidents<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a9ca047 textStyle elementor-widget elementor-widget-text-editor\" data-id=\"a9ca047\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>As the manufacturer of a Class I medical device in accordance with Regulation (EU) 2017\/745 (MDR), Rocket Dental GmbH is legally obliged to operate a vigilance system.<\/p><p>We ask all users and patients to report serious incidents in connection with the medical device RING without delay to:<\/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-932f8c5 e-con e-atomic-element e-flexbox-base e-932f8c5-22642a1 \" data-id=\"932f8c5\" data-element_type=\"e-flexbox\" data-e-type=\"e-flexbox\" data-interaction-id=\"932f8c5\" data-e-type=\"e-flexbox\" data-id=\"932f8c5\">\n    <div class=\"elementor-element elementor-element-a9421bd e-con e-atomic-element e-flexbox-base e-a9421bd-d704245 \" data-id=\"a9421bd\" data-element_type=\"e-flexbox\" data-e-type=\"e-flexbox\" data-interaction-id=\"a9421bd\" data-e-type=\"e-flexbox\" data-id=\"a9421bd\">\n    \t\t<div class=\"elementor-element elementor-element-1a233b8 textStyle elementor-widget elementor-widget-text-editor\" data-id=\"1a233b8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Email<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a0f957b textStyle elementor-widget elementor-widget-text-editor\" data-id=\"a0f957b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><a href=\"mailto:vigilance@rocket.dental\">vigilance@rocket.dental<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\n<\/div>\n<div class=\"elementor-element elementor-element-7779a6a e-con e-atomic-element e-flexbox-base e-7779a6a-4d45818 \" data-id=\"7779a6a\" data-element_type=\"e-flexbox\" data-e-type=\"e-flexbox\" data-interaction-id=\"7779a6a\" data-e-type=\"e-flexbox\" data-id=\"7779a6a\">\n    \t\t<div class=\"elementor-element elementor-element-54aee36 textStyle elementor-widget elementor-widget-text-editor\" data-id=\"54aee36\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Postal address<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e4e4341 textStyle elementor-widget elementor-widget-text-editor\" data-id=\"e4e4341\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Rocket Dental GmbH, Bahnhofstra\u00dfe 24, 79798 Jestetten, Germany<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\n<\/div>\n<div class=\"elementor-element elementor-element-09ccf94 e-con e-atomic-element e-flexbox-base e-09ccf94-c97c989 \" data-id=\"09ccf94\" data-element_type=\"e-flexbox\" data-e-type=\"e-flexbox\" data-interaction-id=\"09ccf94\" data-e-type=\"e-flexbox\" data-id=\"09ccf94\">\n    \t\t<div class=\"elementor-element elementor-element-9f6d316 textStyle elementor-widget elementor-widget-text-editor\" data-id=\"9f6d316\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Phone<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a7796e5 textStyle elementor-widget elementor-widget-text-editor\" data-id=\"a7796e5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>+49 7745 7211<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\n<\/div>\n\n<\/div>\n\t\t<div class=\"elementor-element elementor-element-0206240 titleLegacy elementor-widget elementor-widget-heading\" data-id=\"0206240\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><span>2.<\/span> What Constitutes a Serious Incident?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-15505b7 textStyle elementor-widget elementor-widget-text-editor\" data-id=\"15505b7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>A serious incident within the meaning of Art. 2 No. 65 MDR is any incident that directly or indirectly led, might have led or might lead to any of the following consequences:<\/p><ul><li>the death of a patient, user or other person,<\/li><li>the temporary or permanent serious deterioration of the state of health of a patient, user or other persons,<\/li><li>a serious public health threat.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-569a392 titleLegacy elementor-widget elementor-widget-heading\" data-id=\"569a392\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><span>3.<\/span> Reporting to the Authorities<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c60a9a7 textStyle elementor-widget elementor-widget-text-editor\" data-id=\"c60a9a7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Users and patients also have the option of reporting serious incidents directly to the competent authority:<\/p><p><strong>Federal higher authority<\/strong><\/p><p>Bundesinstitut fuer Arzneimittel und Medizinprodukte (BfArM)<\/p><p>(Federal Institute for Drugs and Medical Devices)\u2028<\/p><p>Kurt-Georg-Kiesinger-Allee 3\u2028<\/p><p>53175 Bonn, Germany<\/p><p><a href=\"http:\/\/www.bfarm.de\" target=\"_blank\" rel=\"noopener\">www.bfarm.de<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-66c2430 textStyle elementor-widget elementor-widget-text-editor\" data-id=\"66c2430\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Competent state authority of Baden-Wuerttemberg<\/strong><\/p><p>Regierungspraesidium Freiburg<\/p><p>Referat 25 &#8211; Aerztliche und pharmazeutische Angelegenheiten, Medizinprodukte\u2028<\/p><p>(Regional Council of Freiburg, Unit 25 &#8211; Medical and Pharmaceutical Affairs, Medical Devices)<\/p><p>Bissierstrasse 7\u2028<\/p><p>79114 Freiburg, Germany<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-33b701c titleLegacy elementor-widget elementor-widget-heading\" data-id=\"33b701c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><span>4.<\/span> What Happens After a Report<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-169a25e textStyle elementor-widget elementor-widget-text-editor\" data-id=\"169a25e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>We will promptly confirm receipt of your report, examine the facts and, where necessary, take the required measures. In the case of serious incidents, the report is made to the competent authorities in accordance with Art. 87 MDR within the statutory deadlines.<\/p><p>Data protection: your report data will be processed exclusively for the purpose of handling the safety report and fulfilling legal obligations. See our <a href=\"https:\/\/rocket.dental\/en\/privacy-policy\/\">Privacy Policy<\/a>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-10ab0e5 titleLegacy elementor-widget elementor-widget-heading\" data-id=\"10ab0e5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><span>5.<\/span> EU Declaration of Conformity<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f12faf7 textStyle elementor-widget elementor-widget-text-editor\" data-id=\"f12faf7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>An EU Declaration of Conformity in accordance with Art. 19 of Regulation (EU) 2017\/745 (MDR) has been issued for the medical device RING. The product bears the CE marking and is placed on the market in accordance with the applicable requirements of the MDR.<\/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-67546ae e-con e-atomic-element e-flexbox-base e-67546ae-a838116 \" data-id=\"67546ae\" data-element_type=\"e-flexbox\" data-e-type=\"e-flexbox\" data-interaction-id=\"67546ae\" data-e-type=\"e-flexbox\" data-id=\"67546ae\">\n    <div class=\"elementor-element elementor-element-46cca88 e-con e-atomic-element e-flexbox-base e-46cca88-897aec2 \" data-id=\"46cca88\" data-element_type=\"e-flexbox\" data-e-type=\"e-flexbox\" data-interaction-id=\"46cca88\" data-e-type=\"e-flexbox\" data-id=\"46cca88\">\n    \t\t<div class=\"elementor-element elementor-element-3675226 textStyle elementor-widget elementor-widget-text-editor\" data-id=\"3675226\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Date of CE marking:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6c03e70 textStyle elementor-widget elementor-widget-text-editor\" data-id=\"6c03e70\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>15 July 2026<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\n<\/div>\n<div class=\"elementor-element elementor-element-e672e95 e-con e-atomic-element e-flexbox-base e-e672e95-181423e \" data-id=\"e672e95\" data-element_type=\"e-flexbox\" data-e-type=\"e-flexbox\" data-interaction-id=\"e672e95\" data-e-type=\"e-flexbox\" data-id=\"e672e95\">\n    \t\t<div class=\"elementor-element elementor-element-92d7f23 textStyle elementor-widget elementor-widget-text-editor\" data-id=\"92d7f23\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Date of the Declaration of Conformity:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-78177e5 textStyle elementor-widget elementor-widget-text-editor\" data-id=\"78177e5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>15 July 2026 (<strong>v<\/strong>ersion 01<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\n<\/div>\n<div class=\"elementor-element elementor-element-b0baa85 e-con e-atomic-element e-flexbox-base e-b0baa85-bd68cdb \" data-id=\"b0baa85\" data-element_type=\"e-flexbox\" data-e-type=\"e-flexbox\" data-interaction-id=\"b0baa85\" data-e-type=\"e-flexbox\" data-id=\"b0baa85\">\n    \t\t<div class=\"elementor-element elementor-element-d4a11d3 textStyle elementor-widget elementor-widget-text-editor\" data-id=\"d4a11d3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>MDR classification:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b561952 textStyle elementor-widget elementor-widget-text-editor\" data-id=\"b561952\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Class I in accordance with Annex VIII, Rule 5 of Regulation (EU) 2017\/745.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\n<\/div>\n\n<\/div>\n\n<\/div>\n\n<\/div>\n\n<\/div>\n\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Safety Reporting &#8211; Vigilance 1. Reporting Serious Incidents As the manufacturer of a Class I medical device in accordance with Regulation (EU) 2017\/745 (MDR), Rocket Dental GmbH is legally obliged to operate a vigilance system. We ask all users and patients to report serious incidents in connection with the medical device RING without delay to: [&hellip;]<\/p>\n","protected":false},"author":11,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-73941","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/rocket.dental\/en\/wp-json\/wp\/v2\/pages\/73941","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rocket.dental\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/rocket.dental\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/rocket.dental\/en\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/rocket.dental\/en\/wp-json\/wp\/v2\/comments?post=73941"}],"version-history":[{"count":61,"href":"https:\/\/rocket.dental\/en\/wp-json\/wp\/v2\/pages\/73941\/revisions"}],"predecessor-version":[{"id":75490,"href":"https:\/\/rocket.dental\/en\/wp-json\/wp\/v2\/pages\/73941\/revisions\/75490"}],"wp:attachment":[{"href":"https:\/\/rocket.dental\/en\/wp-json\/wp\/v2\/media?parent=73941"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}