{"id":258861,"date":"2021-12-07T07:55:50","date_gmt":"2021-12-07T06:55:50","guid":{"rendered":"https:\/\/www2.vbm-medical.de\/person-responsible-for-regulatory-compliance\/"},"modified":"2023-04-17T13:58:26","modified_gmt":"2023-04-17T11:58:26","slug":"medical-device-reporting","status":"publish","type":"page","link":"https:\/\/www.vbm-medical.de\/en\/contact\/medical-device-reporting\/","title":{"rendered":"Medical Device Reporting"},"content":{"rendered":"<p>[et_pb_section fb_built=\"1\" admin_label=\"Section\" _builder_version=\"4.16\" _module_preset=\"default\" background_color=\"RGBA(255,255,255,0)\" background_color_gradient_direction=\"14deg\" background_color_gradient_start=\"#f2f2f3\" background_color_gradient_end=\"#f9f9f9\" background_image=\"https:\/\/www.vbm-medical.de\/wp-content\/uploads\/2021\/12\/PIC01826_ResponsiblePerson_MockupHero_001_Hero.webp\" background_enable_image=\"on\" background_enable_video_mp4=\"off\" min_height=\"528px\" min_height_tablet=\"278px\" min_height_phone=\"128px\" min_height_last_edited=\"on|phone\" custom_margin=\"0px||80px||false|false\" custom_margin_tablet=\"||16px||false|false\" custom_margin_phone=\"||16px||false|false\" parallax_phone=\"off\" da_disable_devices=\"off|off|off\" border_width_top=\"1px\" locked=\"off\" global_colors_info=\"{}\" background__hover_enabled=\"off|desktop\" da_is_popup=\"off\" da_exit_intent=\"off\" da_has_close=\"on\" da_alt_close=\"off\" da_dark_close=\"off\" da_not_modal=\"on\" da_is_singular=\"off\" da_with_loader=\"off\" da_has_shadow=\"on\"][et_pb_row _builder_version=\"4.16\" _module_preset=\"default\" global_colors_info=\"{}\"][et_pb_column type=\"4_4\" _builder_version=\"4.16\" _module_preset=\"default\" global_colors_info=\"{}\"][et_pb_image src=\"https:\/\/www.vbm-medical.de\/wp-content\/uploads\/2021\/12\/PIC01826_ResponsiblePerson_MockupHero_001_16zu9.webp\" title_text=\"PIC01826_ResponsiblePerson_MockupHero_001_16zu9\" disabled_on=\"off|off|on\" _builder_version=\"4.16\" _module_preset=\"default\" max_height=\"528px\" global_colors_info=\"{}\"][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\"1\" admin_label=\"Section\" _builder_version=\"4.20.2\" _module_preset=\"default\" custom_margin=\"||43px||false|false\" da_disable_devices=\"off|off|off\" locked=\"off\" global_colors_info=\"{}\" da_is_popup=\"off\" da_exit_intent=\"off\" da_has_close=\"on\" da_alt_close=\"off\" da_dark_close=\"off\" da_not_modal=\"on\" da_is_singular=\"off\" da_with_loader=\"off\" da_has_shadow=\"on\"][et_pb_row _builder_version=\"4.16\" _module_preset=\"default\" background_color=\"RGBA(0,0,0,0)\" width_tablet=\"\" width_phone=\"\" width_last_edited=\"on|phone\" custom_margin=\"||0px||false|false\" custom_margin_tablet=\"||0px||false|false\" custom_margin_phone=\"||0px||false|false\" custom_margin_last_edited=\"on|phone\" custom_padding=\"|0px||0px|false|false\" global_colors_info=\"{}\" custom_padding__hover_enabled=\"off|desktop\"][et_pb_column type=\"4_4\" _builder_version=\"4.16\" _module_preset=\"default\" global_colors_info=\"{}\"][et_pb_text disabled_on=\"off|off|off\" _builder_version=\"4.20.4\" _module_preset=\"default\" header_line_height=\"1.2em\" header_5_font=\"Barlow Semi Condensed|300|||||||\" header_5_font_size=\"20px\" header_5_line_height=\"1.5em\" custom_margin=\"0px|0px|43px|0px|false|false\" custom_margin_tablet=\"||16px||false|false\" custom_margin_phone=\"||16px||false|false\" custom_margin_last_edited=\"on|desktop\" locked=\"off\" global_colors_info=\"{}\"]<\/p>\n<h1><span style=\"color: #009ee3;\">Medical Device Reporting <\/span><\/h1>\n<p>[\/et_pb_text][et_pb_text module_class=\"vbm-bullet\" _builder_version=\"4.20.2\" _module_preset=\"default\" text_font=\"|300|||||||\" text_font_size=\"1.17em\" header_5_font=\"Barlow Semi Condensed|300|||||||\" header_5_font_size=\"20px\" header_5_line_height=\"1.5em\" custom_margin=\"0px|0px|16px|0px|false|false\" text_font_size_last_edited=\"off|desktop\" global_colors_info=\"{}\"]<\/p>\n<ul>\n<li><span style=\"font-size: 1.17em;\">Would you like to report a malfunction of a VBM-product, which led to death or a serious deterioration in the state of health of a patient, user or third person?<br \/><\/span><\/li>\n<li><span style=\"font-size: 1.17em;\">Would you like to report a malfunction of a VBM-product, which could have led to death or a serious deterioration in the state of health of a patient, user or third person?<\/span><\/li>\n<li><span style=\"font-size: 1.17em;\">Did you face a critical situation with a VBM-product and need further support?<\/span><\/li>\n<\/ul>\n<p>[\/et_pb_text][et_pb_text module_class=\"vbm-bullet\" _builder_version=\"4.20.2\" _module_preset=\"default\" header_5_font=\"Barlow Semi Condensed|300|||||||\" header_5_font_size=\"20px\" header_5_line_height=\"1.5em\" custom_margin=\"0px|0px|16px|0px|false|false\" global_colors_info=\"{}\"]<\/p>\n<p><span style=\"font-size: 1.17em;\">Please contact us with the help of the below contact form. We will get back to you as soon as possible.<br \/><\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\"1\" admin_label=\"Section\" _builder_version=\"4.16\" _module_preset=\"default\" custom_margin=\"||200px||false|false\" custom_margin_tablet=\"||112px||false|false\" custom_margin_phone=\"||112px||false|false\" da_disable_devices=\"off|off|off\" locked=\"off\" global_colors_info=\"{}\" da_is_popup=\"off\" da_exit_intent=\"off\" da_has_close=\"on\" da_alt_close=\"off\" da_dark_close=\"off\" da_not_modal=\"on\" da_is_singular=\"off\" da_with_loader=\"off\" da_has_shadow=\"on\"][et_pb_row make_equal=\"off\" _builder_version=\"4.16\" _module_preset=\"default\" custom_margin=\"||43px||false|false\" custom_margin_tablet=\"||43px||false|false\" custom_margin_phone=\"||43px||false|false\" custom_margin_last_edited=\"on|phone\" locked=\"off\" global_colors_info=\"{}\"][et_pb_column type=\"4_4\" _builder_version=\"4.16\" _module_preset=\"default\" background_color=\"#f2f2f3\" custom_padding=\"0px|0px|0px|0px|false|false\" global_colors_info=\"{}\"][et_pb_text content_last_edited=\"off|desktop\" admin_label=\"VBM_ModulHeadline\" _builder_version=\"4.16\" _module_preset=\"default\" text_font_size=\"1.72em\" header_2_font_size=\"1.5em\" header_5_font_size=\"18px\" background_color=\"#FFFFFF\" custom_margin_tablet=\"\" custom_margin_phone=\"\" custom_margin_last_edited=\"on|tablet\" custom_padding=\"0px|0px|43px|0px|false|false\" custom_padding_tablet=\"|0px|24px|0px|false|false\" custom_padding_phone=\"0px|0px|24px|0px|false|false\" text_font_size_tablet=\"1.61em\" text_font_size_phone=\"1.56em\" header_2_font_size_tablet=\"1.39em\" header_2_font_size_phone=\"1.33em\" background_color_tablet=\"#FFFFFF\" background_color_phone=\"#FFFFFF\" background_enable_color_tablet=\"on\" background_enable_color_phone=\"on\" custom_css_main_element=\"font-weight: 500;\" saved_tabs=\"all\" locked=\"off\" global_colors_info=\"{}\"]<\/p>\n<p style=\"text-align: left;\"><span style=\"color: #009ee3; letter-spacing: -0.1em; padding-right: 16px;\">\u2014\u2014<\/span>Contact form Person Responsible for Regulatory Compliance<\/p>\n<p>[\/et_pb_text][et_pb_text _builder_version=\"4.16\" _module_preset=\"default\" custom_padding=\"48px|48px|16px|48px|false|false\" custom_padding_tablet=\"48px|48px|16px|48px|false|false\" custom_padding_phone=\"48px|48px|16px|48px|false|false\" global_colors_info=\"{}\"]<\/p>\n<h5>Your data<\/h5>\n<p>[\/et_pb_text][et_pb_contact_form use_spam_service=\"on\" recaptcha_list=\"Google reCAPTCHA v3|Google reCAPTCHA v3-0\" recaptcha_min_score=\"0.9\" email=\"fieldsafetynotice@vbm-medical.de\" custom_message=\"Lieber Empf\u00e4nger,||et_pb_line_break_holder||||et_pb_line_break_holder||\u00fcber das Kontaktformular der Seite %22Verantwortliche Person%22 auf der VBM Website wurden folgende Daten bzw. folgende Nachricht \u00fcbermittelt:||et_pb_line_break_holder||||et_pb_line_break_holder||Anrede \/ Titel: ||et_pb_line_break_holder||%%Anrede_\/_Titel%%||et_pb_line_break_holder||||et_pb_line_break_holder||Vorname:||et_pb_line_break_holder||%%Vorname%%||et_pb_line_break_holder||||et_pb_line_break_holder||Nachname*: ||et_pb_line_break_holder||%%Nachname%%||et_pb_line_break_holder||||et_pb_line_break_holder||E-Mail-Adresse*: ||et_pb_line_break_holder||%%Email%%||et_pb_line_break_holder||||et_pb_line_break_holder||Telefonnummer:||et_pb_line_break_holder||%%Telefon%%||et_pb_line_break_holder||||et_pb_line_break_holder||Firma \/ Krankenhaus:||et_pb_line_break_holder||%%Unternehmen%%||et_pb_line_break_holder||||et_pb_line_break_holder||Abteilung:||et_pb_line_break_holder||%%Abteilung%%||et_pb_line_break_holder||||et_pb_line_break_holder||Anschrift:||et_pb_line_break_holder||%%Anschrift%%||et_pb_line_break_holder||||et_pb_line_break_holder||PLZ und Ort:||et_pb_line_break_holder||%%PLZ_Ort%%||et_pb_line_break_holder||||et_pb_line_break_holder||Land:||et_pb_line_break_holder||%%Land%%||et_pb_line_break_holder||||et_pb_line_break_holder||Kundennummer:||et_pb_line_break_holder||%%KundenNr%%||et_pb_line_break_holder||||et_pb_line_break_holder||Kunden Referenz*:||et_pb_line_break_holder||%%KundenReferenz%%||et_pb_line_break_holder||||et_pb_line_break_holder||Produkt*:||et_pb_line_break_holder||%%Produkt%%||et_pb_line_break_holder||||et_pb_line_break_holder||Artikel-Nr.*:||et_pb_line_break_holder||%%ArtikelNr%%||et_pb_line_break_holder||||et_pb_line_break_holder||Seriennummer \/ Lot-Nr.*:||et_pb_line_break_holder||%%Seriennummer%%||et_pb_line_break_holder||||et_pb_line_break_holder||Menge*:||et_pb_line_break_holder||%%Menge%%||et_pb_line_break_holder||||et_pb_line_break_holder||Beschwerde \/ R\u00fcckmeldung*:||et_pb_line_break_holder||%%Rueckmeldung%%||et_pb_line_break_holder||||et_pb_line_break_holder||Wurde das Produkt am Patienten angewendet?*:||et_pb_line_break_holder||%%Patientenanwendung%%||et_pb_line_break_holder||||et_pb_line_break_holder||Kam es w\u00e4hrend der Anwendung zu einer potenziellen Patientensch\u00e4digung?*:||et_pb_line_break_holder||%%Patientenschaedigung%%||et_pb_line_break_holder||||et_pb_line_break_holder||Wurde das Problem bereits an eine Beh\u00f6rde gemeldet?*:||et_pb_line_break_holder||%%Meldung_Behoerde%%||et_pb_line_break_holder||||et_pb_line_break_holder||Wie ist der gegenw\u00e4rtige Verbleib des Produktes?*:||et_pb_line_break_holder||%%Verbleib_Produkt%%||et_pb_line_break_holder||||et_pb_line_break_holder||Die mit *Stern gekennzeichneten Felder sind Pflichtfelder.\" success_message=\"Your message was successfully sent. We will take care of your request as soon as possible.\" submit_button_text=\"Send\" _builder_version=\"4.16\" _module_preset=\"default\" _unique_id=\"58aa3bf8-b879-41f3-8184-35c4da1419d7\" form_field_background_color=\"#FFFFFF\" form_field_text_color=\"rgba(0,0,0,0.5)\" title_level=\"h3\" title_font=\"Barlow Semi Condensed||||||||\" title_line_height=\"2em\" form_field_font=\"Barlow Semi Condensed||||||||\" form_field_font_size=\"16px\" custom_button=\"on\" button_text_size=\"18px\" button_font=\"Barlow Semi Condensed||||||||\" button_use_icon=\"off\" button_custom_padding=\"5px|16px|4px|16px|false|false\" custom_padding=\"|43px|0px|48px|false|false\" title_font_size_tablet=\"20px\" title_font_size_phone=\"20px\" title_font_size_last_edited=\"on|tablet\" locked=\"off\" global_colors_info=\"{}\"][et_pb_contact_field field_id=\"Anrede_\/_Titel\" field_title=\"Title\" required_mark=\"off\" fullwidth_field=\"on\" _builder_version=\"4.16\" _module_preset=\"default\" 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field_id=\"Anschrift\" field_title=\"Adress\" required_mark=\"off\" fullwidth_field=\"on\" _builder_version=\"4.16\" _module_preset=\"default\" global_colors_info=\"{}\"][\/et_pb_contact_field][et_pb_contact_field field_id=\"PLZ_Ort\" field_title=\"Postcode City\" required_mark=\"off\" fullwidth_field=\"on\" _builder_version=\"4.16\" _module_preset=\"default\" global_colors_info=\"{}\"][\/et_pb_contact_field][et_pb_contact_field field_id=\"Land\" field_title=\"Country\" required_mark=\"off\" fullwidth_field=\"on\" _builder_version=\"4.16\" _module_preset=\"default\" global_colors_info=\"{}\"][\/et_pb_contact_field][et_pb_contact_field field_id=\"KundenNr\" field_title=\"Customer \/ Customer ID\" required_mark=\"off\" _builder_version=\"4.16\" _module_preset=\"default\" global_colors_info=\"{}\"][\/et_pb_contact_field][et_pb_contact_field field_id=\"KundenReferenz\" field_title=\"Customer Reference*\" _builder_version=\"4.16\" _module_preset=\"default\" global_colors_info=\"{}\"][\/et_pb_contact_field][et_pb_contact_field field_id=\"Produkt\" field_title=\"Product*\" _builder_version=\"4.16\" _module_preset=\"default\" global_colors_info=\"{}\"][\/et_pb_contact_field][et_pb_contact_field field_id=\"ArtikelNr\" field_title=\"Product Code*\" _builder_version=\"4.16\" _module_preset=\"default\" global_colors_info=\"{}\"][\/et_pb_contact_field][et_pb_contact_field field_id=\"Seriennummer\" field_title=\"Serial-No. \/ Batch-No.*\" _builder_version=\"4.16\" _module_preset=\"default\" global_colors_info=\"{}\"][\/et_pb_contact_field][et_pb_contact_field field_id=\"Menge\" field_title=\"Amount of concerned products*\" _builder_version=\"4.16\" _module_preset=\"default\" global_colors_info=\"{}\"][\/et_pb_contact_field][et_pb_contact_field field_id=\"Rueckmeldung\" field_title=\"Reason for complaint*\" field_type=\"text\" fullwidth_field=\"on\" _builder_version=\"4.16\" _module_preset=\"default\" global_colors_info=\"{}\"][\/et_pb_contact_field][et_pb_contact_field field_id=\"Patientenanwendung\" field_title=\"Was the product used on a patient?*\" field_type=\"radio\" radio_options=\"%91{%22value%22:%22Yes%22,%22checked%22:0,%22dragID%22:-1},{%22value%22:%22No%22,%22checked%22:0,%22dragID%22:0}%93\" _builder_version=\"4.16\" _module_preset=\"default\" global_colors_info=\"{}\"][\/et_pb_contact_field][et_pb_contact_field field_id=\"Patientenschaedigung\" field_title=\"Was the patient harmed during use of the VBM-product?*\" field_type=\"radio\" radio_options=\"%91{%22value%22:%22Yes%22,%22checked%22:0,%22dragID%22:-1},{%22value%22:%22No%22,%22checked%22:0,%22dragID%22:0}%93\" _builder_version=\"4.16\" _module_preset=\"default\" global_colors_info=\"{}\"][\/et_pb_contact_field][et_pb_contact_field field_id=\"Meldung_Behoerde\" field_title=\"Was the complaint already forwarded to a competent authority?*\" fullwidth_field=\"on\" _builder_version=\"4.16\" _module_preset=\"default\" global_colors_info=\"{}\"][\/et_pb_contact_field][et_pb_contact_field field_id=\"Verbleib_Produkt\" field_title=\"What is the current status of the product?*\" fullwidth_field=\"on\" _builder_version=\"4.16\" _module_preset=\"default\" global_colors_info=\"{}\"][\/et_pb_contact_field][\/et_pb_contact_form][et_pb_text _builder_version=\"4.17.4\" _module_preset=\"default\" custom_margin=\"0px|0px|0px||false|false\" custom_padding=\"0px|43px|43px|48px|false|false\" custom_padding_tablet=\"|48px|43px|48px|false|false\" custom_padding_phone=\"0px|48px|43px|48px|false|false\" locked=\"off\" global_colors_info=\"{}\"]<span style=\"font-weight: 500;\">Data protection notice for the contact form<\/span><br \/>\nIf you send us enquiries via this contact form, your details from the enquiry form, including the contact details you provide there, will be stored by us for the purpose of processing the enquiry and in the event of follow-up questions. We will not pass on this data without your consent.<\/p>\n<p>The processing of this data is based on Article 6, para. 1, sentence 1 lit. f GDPR if your request is related to the performance of a contract or is necessary for the implementation of pre-contractual measures. In all other cases, the processing is based on our legitimate interest in the effective processing of the enquiries addressed to us (Article 6, para. 1, sentence 1 lit. f GDPR) or on your consent (Article 6, para. 1, sentence 1 lit. f GDPR) if this has been requested; consent can be revoked at any time.<\/p>\n<p>The data you enter in the contact form will remain with us until you request us to delete it, revoke your consent to store it or the purpose for storing the data no longer applies (e.g. after we have completed processing your enquiry).<\/p>\n<p>You can find our detailed data protection notice here: <a href=\"https:\/\/www.vbm-medical.de\/en\/privacy-policy\/\" class=\"link\"><span style=\"color: #009ee3; font-weight: 400;\">Data Protection Notice<\/span><\/a><\/p>\n<p>You can find your data subject rights according to the GDPR here: <span style=\"color: #008080;\"><a href=\"https:\/\/media.vbm-medical.de\/cor\/Betroffenenrechte_Allgemein.pdf\" target=\"_blank\" rel=\"noopener\" style=\"color: #009ee3; font-weight: 400;\">Data subject rights according to the GDPR<\/a><\/span>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=\"1\" _builder_version=\"4.16\" _module_preset=\"default\" module_alignment=\"left\" custom_margin=\"||8px||false|false\" custom_margin_tablet=\"||7px||false|false\" custom_margin_phone=\"||8px||false|false\" da_disable_devices=\"off|off|off\" locked=\"off\" global_colors_info=\"{}\" da_is_popup=\"off\" da_exit_intent=\"off\" da_has_close=\"on\" da_alt_close=\"off\" da_dark_close=\"off\" da_not_modal=\"on\" da_is_singular=\"off\" da_with_loader=\"off\" da_has_shadow=\"on\"][et_pb_row _builder_version=\"4.16\" _module_preset=\"default\" global_colors_info=\"{}\"][et_pb_column type=\"4_4\" _builder_version=\"4.16\" _module_preset=\"default\" global_colors_info=\"{}\"][et_pb_text _builder_version=\"4.20.4\" _module_preset=\"default\" text_font_size=\"0.8em\" text_font_size_tablet=\"0.8em\" text_font_size_phone=\"0.8em\" global_colors_info=\"{}\"]<\/p>\n<p><span>WEB001_PID-00-05-03_AB_EN<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Medical Device Reporting Would you like to report a malfunction of a VBM-product, which led to death or a serious deterioration in the state of health of a patient, user or third person? Would you like to report a malfunction of a VBM-product, which could have led to death or a serious deterioration in the [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":258885,"menu_order":3,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"tags":[],"class_list":["post-258861","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.vbm-medical.de\/en\/wp-json\/wp\/v2\/pages\/258861","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.vbm-medical.de\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.vbm-medical.de\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.vbm-medical.de\/en\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/www.vbm-medical.de\/en\/wp-json\/wp\/v2\/comments?post=258861"}],"version-history":[{"count":36,"href":"https:\/\/www.vbm-medical.de\/en\/wp-json\/wp\/v2\/pages\/258861\/revisions"}],"predecessor-version":[{"id":273291,"href":"https:\/\/www.vbm-medical.de\/en\/wp-json\/wp\/v2\/pages\/258861\/revisions\/273291"}],"up":[{"embeddable":true,"href":"https:\/\/www.vbm-medical.de\/en\/wp-json\/wp\/v2\/pages\/258885"}],"wp:attachment":[{"href":"https:\/\/www.vbm-medical.de\/en\/wp-json\/wp\/v2\/media?parent=258861"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.vbm-medical.de\/en\/wp-json\/wp\/v2\/tags?post=258861"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}