{"id":73423,"date":"2026-06-30T09:36:38","date_gmt":"2026-06-30T09:36:38","guid":{"rendered":"https:\/\/rocket.dental\/?page_id=73423"},"modified":"2026-08-14T07:18:19","modified_gmt":"2026-08-14T07:18:19","slug":"sicherheit","status":"publish","type":"page","link":"https:\/\/rocket.dental\/de\/sicherheit\/","title":{"rendered":"Sicherheitsmeldungen &#8211; Vigilance"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"73423\" class=\"elementor 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\">Sicherheitsmeldungen - 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> Schwerwiegende Vorkommnisse melden<\/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>Als Hersteller eines Medizinprodukts der Klasse I gem\u00e4\u00df der Verordnung (EU) 2017\/745 (MDR) ist die Rocket Dental GmbH gesetzlich verpflichtet, ein Vigilance-System zu betreiben.<\/p><p>Wir bitten alle Anwender und Patienten, schwerwiegende Vorkommnisse im Zusammenhang mit dem Medizinprodukt RING unverz\u00fcglich zu melden, und zwar an:<\/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>E-Mail<\/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>Postanschrift<\/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, Deutschland<\/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>Telefon<\/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> Was gilt als schwerwiegendes Vorkommnis?<\/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>Ein schwerwiegendes Vorkommnis im Sinne von Art. 2 Nr. 65 MDR ist jedes Vorkommnis, das direkt oder indirekt eine der nachfolgenden Folgen hatte, h\u00e4tte haben k\u00f6nnen oder haben k\u00f6nnte:<\/p><ul><li>den Tod eines Patienten, Anwenders oder einer anderen Person,<\/li><li>die vor\u00fcbergehende oder dauerhafte schwerwiegende Verschlechterung des Gesundheitszustands eines Patienten, Anwenders oder anderer Personen,<\/li><li>eine schwerwiegende Gefahr f\u00fcr die \u00f6ffentliche Gesundheit.<\/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> Meldung an Beh\u00f6rden<\/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>Anwender und Patienten haben zus\u00e4tzlich die M\u00f6glichkeit, schwerwiegende Vorkommnisse direkt an die zust\u00e4ndige Beh\u00f6rde zu melden:<\/p><p><strong>Bundesoberbeh\u00f6rde<\/strong><\/p><p>Bundesinstitut f\u00fcr Arzneimittel und Medizinprodukte (BfArM)<\/p><p>Kurt-Georg-Kiesinger-Allee 3<\/p><p>53175 Bonn<\/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-a780114 textStyle elementor-widget elementor-widget-text-editor\" data-id=\"a780114\" 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>Zust\u00e4ndige Landesbeh\u00f6rde Baden-W\u00fcrttemberg<\/strong><\/p><p>Regierungspr\u00e4sidium Freiburg<\/p><p>Referat 25 &#8211; \u00c4rztliche und pharmazeutische Angelegenheiten, Medizinprodukte<\/p><p>Bissierstra\u00dfe 7<\/p><p>79114 Freiburg<\/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> Was passiert nach einer Meldung<\/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>Wir best\u00e4tigen den Eingang Ihrer Meldung zeitnah, pr\u00fcfen den Sachverhalt und ergreifen gegebenenfalls die erforderlichen Ma\u00dfnahmen. Bei schwerwiegenden Vorkommnissen erfolgt die Meldung an die zust\u00e4ndigen Beh\u00f6rden gem\u00e4\u00df Art. 87 MDR innerhalb der gesetzlich vorgegebenen Fristen.<\/p><p>Datenschutz: Ihre Meldedaten werden ausschlie\u00dflich zur Bearbeitung der Sicherheitsmeldung und zur Erf\u00fcllung gesetzlicher Pflichten verarbeitet. Siehe <a href=\"https:\/\/rocket.dental\/de\/datenschutz\/\" target=\"_blank\" rel=\"noopener\">Datenschutzerkl\u00e4rung<\/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-Konformit\u00e4tserkl\u00e4rung<\/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>F\u00fcr das Medizinprodukt RING wurde eine EU-Konformit\u00e4tserkl\u00e4rung gem\u00e4\u00df Art. 19 der Verordnung (EU) 2017\/745 (MDR) erstellt. Das Produkt ist mit der CE-Kennzeichnung versehen und wird entsprechend den geltenden Anforderungen der MDR in Verkehr gebracht.<\/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>Datum der CE-Kennzeichnung:<\/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\t15.07.2026\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>DoC-Datum:<\/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\t15.07.2026 (Version 01)\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-Klassifizierung:<\/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>Klasse I gem\u00e4\u00df Anhang VIII, Regel 5 der Verordnung (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>Sicherheitsmeldungen &#8211; Vigilance 1. Schwerwiegende Vorkommnisse melden Als Hersteller eines Medizinprodukts der Klasse I gem\u00e4\u00df der Verordnung (EU) 2017\/745 (MDR) ist die Rocket Dental GmbH gesetzlich verpflichtet, ein Vigilance-System zu betreiben. Wir bitten alle Anwender und Patienten, schwerwiegende Vorkommnisse im Zusammenhang mit dem Medizinprodukt RING unverz\u00fcglich zu melden, und zwar an: E-Mail vigilance@rocket.dental Postanschrift Rocket [&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-73423","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/rocket.dental\/de\/wp-json\/wp\/v2\/pages\/73423","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rocket.dental\/de\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/rocket.dental\/de\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/rocket.dental\/de\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/rocket.dental\/de\/wp-json\/wp\/v2\/comments?post=73423"}],"version-history":[{"count":125,"href":"https:\/\/rocket.dental\/de\/wp-json\/wp\/v2\/pages\/73423\/revisions"}],"predecessor-version":[{"id":75319,"href":"https:\/\/rocket.dental\/de\/wp-json\/wp\/v2\/pages\/73423\/revisions\/75319"}],"wp:attachment":[{"href":"https:\/\/rocket.dental\/de\/wp-json\/wp\/v2\/media?parent=73423"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}