{"id":187,"date":"2023-04-20T14:19:36","date_gmt":"2023-04-20T12:19:36","guid":{"rendered":"https:\/\/ceiso.fr\/en\/?page_id=187"},"modified":"2023-07-07T18:40:24","modified_gmt":"2023-07-07T16:40:24","slug":"faq","status":"publish","type":"page","link":"https:\/\/ceiso.fr\/en\/faq\/","title":{"rendered":"FAQ"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"187\" class=\"elementor elementor-187\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-d2a34ff elementor-reverse-tablet elementor-reverse-mobile elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"d2a34ff\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-73cb6fe\" data-id=\"73cb6fe\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e235b68 elementor-widget elementor-widget-heading\" data-id=\"e235b68\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.12.2 - 23-04-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h2 class=\"elementor-heading-title elementor-size-default\">Questions\/answers<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2238eb6 elementor-widget elementor-widget-text-editor\" data-id=\"2238eb6\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.12.2 - 23-04-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p>If you can&#8217;t find what you are looking for, please <a href=\"https:\/\/ceiso.fr\/en\/contact\/\">contact us.<\/a><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1b6c27b elementor-widget elementor-widget-accordion\" data-id=\"1b6c27b\" data-element_type=\"widget\" data-widget_type=\"accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.12.2 - 23-04-2023 *\/\n.elementor-accordion{text-align:left}.elementor-accordion .elementor-accordion-item{border:1px solid #d5d8dc}.elementor-accordion .elementor-accordion-item+.elementor-accordion-item{border-top:none}.elementor-accordion .elementor-tab-title{margin:0;padding:15px 20px;font-weight:700;line-height:1;cursor:pointer;outline:none}.elementor-accordion .elementor-tab-title .elementor-accordion-icon{display:inline-block;width:1.5em}.elementor-accordion .elementor-tab-title .elementor-accordion-icon svg{width:1em;height:1em}.elementor-accordion .elementor-tab-title .elementor-accordion-icon.elementor-accordion-icon-right{float:right;text-align:right}.elementor-accordion .elementor-tab-title .elementor-accordion-icon.elementor-accordion-icon-left{float:left;text-align:left}.elementor-accordion .elementor-tab-title .elementor-accordion-icon .elementor-accordion-icon-closed{display:block}.elementor-accordion .elementor-tab-title .elementor-accordion-icon .elementor-accordion-icon-opened,.elementor-accordion .elementor-tab-title.elementor-active .elementor-accordion-icon-closed{display:none}.elementor-accordion .elementor-tab-title.elementor-active .elementor-accordion-icon-opened{display:block}.elementor-accordion .elementor-tab-content{display:none;padding:15px 20px;border-top:1px solid #d5d8dc}@media (max-width:767px){.elementor-accordion .elementor-tab-title{padding:12px 15px}.elementor-accordion .elementor-tab-title .elementor-accordion-icon{width:1.2em}.elementor-accordion .elementor-tab-content{padding:7px 15px}}.e-con-inner>.elementor-widget-accordion,.e-con>.elementor-widget-accordion{width:var(--container-widget-width);--flex-grow:var(--container-widget-flex-grow)}<\/style>\t\t<div class=\"elementor-accordion\" role=\"tablist\">\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2871\" class=\"elementor-tab-title\" data-tab=\"1\" role=\"tab\" aria-controls=\"elementor-tab-content-2871\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">Fake item<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2871\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"1\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-2871\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2872\" class=\"elementor-tab-title\" data-tab=\"2\" role=\"tab\" aria-controls=\"elementor-tab-content-2872\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">What is the European Nomenclature for Medical Devices?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2872\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"2\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-2872\"><p>The European Medical Device Nomenclature (EMDN) aims to support the functioning of the European database on medical devices (EUDAMED) in accordance with Article 26 of Regulation (EU) 2017\/745 on medical devices (MDR) and Article 23 of Regulation (EU) 2017\/746 on in vitro diagnostic medical devices (IVDR). Among its various uses, it will be used by manufacturers for the registration of medical devices in EUDAMED, where it will be associated with each unique device identifier (UDI-DI).<\/p><p>As the EMDN serves mainly regulatory purposes to support MDR and IVDR requirements, it also plays a key role in the documentation and technical documentation of MDR\/IVDR devices, the sampling of technical documentation performed by notified bodies, post-market surveillance, vigilance, and post-market data analysis, etc. It is intended to support all actors in their activities under the MDR\/IVDR and provides patients with key descriptions of devices regarding their own devices and all other devices available on the market and registered in EUDAMED.<\/p><p>The EMDN is accessible and downloadable in pdf and excel format by following this link: <a href=\"https:\/\/webgate.ec.europa.eu\/dyna2\/emdn\/\">webgate.ec.europa.eu\/dyna2\/emdn<\/a><\/p><p>Source :\u00a0<a href=\"https:\/\/eu-udi.zendesk.com\/hc\/fr\/articles\/360020878877-Qu-est-ce-que-la-nomenclature-europ%C3%A9enne-des-dispositifs-m%C3%A9dicaux-\">https:\/\/eu-udi.zendesk.com\/hc\/fr\/articles\/360020878877-Qu-est-ce-que-la-nomenclature-europ%C3%A9enne-des-dispositifs-m%C3%A9dicaux-<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2873\" class=\"elementor-tab-title\" data-tab=\"3\" role=\"tab\" aria-controls=\"elementor-tab-content-2873\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">What is a \"basic UDI-ID\"?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2873\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"3\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-2873\"><div class=\"cmsms_toggle\"><div class=\"cmsms_toggle_inner\"><p>The &#8220;Basic UDI-DI&#8221; is the main access key to information about devices in the Eudamed database. It is referenced in relevant documentation [such as certificates (including the free sale certificate), the EU Declaration of Conformity, technical documentation, and the Summary of Safety and Clinical Performance].<\/p><p>It is intended to identify and connect devices with the same intended purpose, risk class, and essential design and manufacturing characteristics.<\/p><p>It is independent\/separate from the device packaging\/labeling and does not appear on any commercial item. Any Basic UDI-DI must uniquely identify the devices (group) covered by this Basic UDI-DI.<\/p><p>The Basic UDI-DI is the high-level grouping for devices having:<\/p><ul><li>the same intended purpose<\/li><li>same manufacturer<\/li><li>same attributes<\/li><li>essential<\/li><li>characteristics<\/li><\/ul><p>\u00a0<\/p><p>Source: <a href=\"https:\/\/eu-udi.zendesk.com\/hc\/fr\/sections\/360005306717-Questions-fr%C3%A9quemment-pos%C3%A9es\">https:\/\/eu-udi.zendesk.com\/hc\/fr\/sections\/360005306717-Questions-fr%C3%A9quemment-pos%C3%A9es<\/a><\/p><\/div><\/div><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2874\" class=\"elementor-tab-title\" data-tab=\"4\" role=\"tab\" aria-controls=\"elementor-tab-content-2874\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">If a device is sold exclusively in a retail store, is the IUD-IP information required to be provided in AIDC format?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2874\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"4\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-2874\"><div class=\"cmsms_toggle\"><div class=\"cmsms_toggle_inner\"><p>The IUD-IP information is not required to appear in AIDC format on the retail store packaging label if the device is sold exclusively in a retail store. The MDR 2017\/745 excludes IUD-IP information from AIDC format at the retail store packaging level; however, the exception does not apply to the HRI, which must be identified on the retail store packaging. The mentioned exception is defined for the sales packaging level only, so the primary packaging level must comply with the IUD requirements as defined in the MDR (IUD-ID and IUD-IP in AIDC and HRI formats).<\/p><p>Source: Frequently Asked Questions \u2013 Unique Device Identification (UDI) Helpdesk <a href=\"https:\/\/eu-udi.zendesk.com\/hc\/en\">https:\/\/eu-udi.zendesk.com\/hc\/en<\/a> &#8211; UDI FAQ Factsheet (2022)<\/p><\/div><\/div><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2875\" class=\"elementor-tab-title\" data-tab=\"5\" role=\"tab\" aria-controls=\"elementor-tab-content-2875\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">What is the difference between the IUD unit of use and IUD-ID?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2875\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"5\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-2875\"><div class=\"cmsms_toggle\"><div class=\"cmsms_toggle_inner\"><p>The IUD-ID is a unique numeric or alphanumeric code specific to a device model and is also used as a &#8220;key&#8221; to access information stored in an IUD database. The IUD-ID must be unique at each level of device packaging.<\/p><p>This mandatory and fixed part of an IUD identifies the specific product and packaging configuration of a manufacturer.<\/p><p>The Device Identifier (UoU DI) is an identifier (following the IUD rules of the chosen issuing entity) assigned to an individual medical device when an IUD is not labeled on the individual device at the unit of use level. Its purpose is to provide an IUD-ID to identify a device used on a patient when an IUD-ID does not appear on the device label.<\/p><p>For example: if the lowest basic packaging level with an identified IUD has a number of devices greater than 1, a UoU DI must be assigned.<\/p><p>If the device is not directly labeled and the basic quantity of the device is more than one, the UoU ID must be provided in EUDAMED.<\/p><p>The issuing entity of the UoU DI code is the same as the IUD-ID.<\/p><p>The same UoU DI can be used for multiple devices.<\/p><p>According to Annex VI, Part C, Section 1, the UoU-DI is defined as follows:<\/p><p>The UoU DI is used to associate the use of a device with a patient in cases where an IUD is not placed on the individual device at the unit of use level, for example when multiple units of the same device are packaged together.<\/p><p>Source : Frequently Asked Questions \u2013 Unique Device Identification (UDI) Helpdesk<br \/><a href=\"https:\/\/eu-udi.zendesk.com\/hc\/fr\">https:\/\/eu-udi.zendesk.com\/hc\/fr<\/a> \u2013 UDI FAQ Factsheet (2022)<\/p><\/div><\/div><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2876\" class=\"elementor-tab-title\" data-tab=\"6\" role=\"tab\" aria-controls=\"elementor-tab-content-2876\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">If a device is sold exclusively in a retail point of sale, must IUD-IP information be provided in AIDC format?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2876\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"6\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-2876\"><p>IUD-IP information is not required to appear on the AIDC label on the retail packaging if the device is sold exclusively at a retail point of sale. The MDR 2017\/745 excludes IUD-IP information from the AIDC format at the point of sale packaging level, however, the exception does not apply to the HRI, which must be identified on the point of sale packaging. The mentioned exception is defined for the sales packaging level only, so the primary packaging level must comply with the IUD requirements as defined in the MDR (IUD-ID and IUD-IP in AIDC and HRI formats).*<\/p><p>Source: Frequently Asked Questions &#8211; Unique Device Identification (UDI) Helpdesk<br \/><a href=\"https:\/\/eu-udi.zendesk.com\/hc\/fr\">https:\/\/eu-udi.zendesk.com\/hc\/fr<\/a> &#8211; UDI FAQ Factsheet (2022)<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2877\" class=\"elementor-tab-title\" data-tab=\"7\" role=\"tab\" aria-controls=\"elementor-tab-content-2877\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">What is the difference between the UDI and UDI-DI?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2877\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"7\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-2877\"><p>The UDI-DI is a unique numerical or alphanumeric code specific to a device model and is also used as an &#8220;access key&#8221; to information stored in a UDI database. The UDI-DI must be unique at each level of device packaging.<\/p><p>This mandatory and fixed part of a UDI identifies the specific product and packaging configuration of a manufacturer.<\/p><p>The UDI-DI is assigned to an individual medical device when a UDI is not labeled on the individual device at the level of its unit of use. Its purpose is to provide a UDI-DI to identify a device used on a patient when a UDI-DI does not appear on the device label.<\/p><p><br \/>For example: if the lowest basic packaging level with an identified UDI has a device number greater than 1, a UDI-DI must be assigned.<\/p><p>If the device is not directly marked and the basic quantity of the device is greater than one, the UDI-DI must be provided in EUDAMED.<\/p><p>The issuer of the UDI-DI unit code is the same as the UDI-DI.<\/p><p>The same UDI-DI can be used for multiple devices.<\/p><p>In accordance with Annex VI, Part C, Section 1, the UDI-DI is defined as follows: The UDI-DI is used to associate the use of a device with a patient in cases where a UDI is not placed on the individual device at the level of its unit of use, for example, when multiple units of the same device are packaged together. *<\/p><p>Source: Frequently Asked Questions &#8211; Unique Device Identification (UDI) Helpdesk <a href=\"https:\/\/eu-udi.zendesk.com\/hc\/en\">https:\/\/eu-udi.zendesk.com\/hc\/en<\/a> &#8211; UDI FAQ Factsheet (2022)<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2878\" class=\"elementor-tab-title\" data-tab=\"8\" role=\"tab\" aria-controls=\"elementor-tab-content-2878\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">How should an IUD appear on the label or packaging of a device?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2878\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"8\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-2878\"><p>The IUD support (Automatic Identification and Data Capture (AIDC) and Human Readable Interpretation (HRI) of the IUD) must be present on the label or on the device itself and on all higher levels of the device&#8217;s packaging.<\/p><p>If there are significant space constraints on the unit packaging, the IUD support may be placed at the higher packaging level.<\/p><p>The higher packaging levels must have their own unique IUD. Please note that shipping containers will be exempt from this requirement.<\/p><p>The IUD must appear in a plain text\/human-readable information (HRI) version and in a form that uses AIDC technology. AIDC refers to any technology that transmits the unique device identifier or device identifier of a device in a form that can be entered into an electronic patient record or other computer system via an automated process. The HRI consists of readable characters that can be easily read by people.<\/p><p>If there are significant constraints on the use of both AIDC and HRI on the label, only the AIDC format must appear on the label.<\/p><p>For devices intended for use outside of healthcare facilities, such as home care devices, HRI must appear on the label even if it results in no room for AIDC.<\/p><p>For other specific requirements related to the IUD support, please refer to section 4 of Annex VI, Part C, of the two regulations.<\/p><p>For single-use medical devices of class I and IIa medical devices and Class A and Class B IVD medical devices that are individually packaged and labeled, the IUD support is not required to appear on the packaging, but it must appear on a higher packaging level, such as a carton containing multiple devices (individually packaged). However, when the healthcare provider is not expected to have access, in cases such as home care, to the higher packaging level of the device, the IUD must be placed on the packaging (of the individual device).<\/p><p>For devices exclusively intended for retail sale, AIDC IUD-IPs are not required to appear on the point-of-sale packaging.<\/p><p>If the IUD support is easily readable or, in the case of AIDC, scannable, through the device&#8217;s packaging, the placement of the IUD support on the packaging is not required.<\/p><p>Source : Unique Device Identification (UDI) System under the EU medical devices Regulations 2017\/745 and 2017\/74601\/08\/2020<\/p><p><a href=\"https:\/\/health.ec.europa.eu\/medical-devices-topics-interest\/unique-device-identifier-udi_fr\">https:\/\/health.ec.europa.eu\/medical-devices-topics-interest\/unique-device-identifier-udi_fr<\/a> \u2013 FAQ relative au syst\u00e8me IUD<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-2879\" class=\"elementor-tab-title\" data-tab=\"9\" role=\"tab\" aria-controls=\"elementor-tab-content-2879\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">What are the obligations for appointing a medical device vigilance correspondent for manufacturers\/importers\/distributors?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-2879\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"9\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-2879\"><p>Currently, article R. 5212-13 of the French Public Health Code (CSP) stipulates that any manufacturer of medical devices, or their representative, must appoint a medical device vigilance correspondent and communicate their name to the Director General of ANSM.<\/p><p>This provision is subject to change with the forthcoming publication of the implementing decrees of the DM and DMDIV ordinances. However, if maintained, it will continue not to apply to distributors or importers.<\/p><p>Source: <a href=\"https:\/\/ansm.sante.fr\/documents\/reference\/faq-reglement-dm-divers#correspondant_vigilance\">https:\/\/ansm.sante.fr\/documents\/reference\/faq-reglement-dm-divers#correspondant_vigilance<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-28710\" class=\"elementor-tab-title\" data-tab=\"10\" role=\"tab\" aria-controls=\"elementor-tab-content-28710\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">Are medical biology and anatomopathology laboratories required to have a local \u201creactovigilance\u201d correspondent?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-28710\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"10\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-28710\"><p>Article R. 5222-10 of the Public Health Code states that any health cooperation user of in vitro diagnostic medical devices, healthcare professionals, manufacturers or their representatives, importers and distributors, as well as any blood transfusion establishment, must declare a local \u201creactovigilance\u201d correspondent to the ANSM. This provision includes medical biology and anatomopathology laboratories.<\/p><p>This provision may be subject to change with the upcoming publication of the DM and DMDIV ordinances.<\/p><p>Source: <a href=\"https:\/\/ansm.sante.fr\/documents\/reference\/faq-reglement-dm-divers#correspondant_vigilance\">https:\/\/ansm.sante.fr\/documents\/reference\/faq-reglement-dm-divers#correspondant_vigilance<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-28711\" class=\"elementor-tab-title\" data-tab=\"11\" role=\"tab\" aria-controls=\"elementor-tab-content-28711\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">If a manufacturer is informed by the ANSM of the declaration of an incident formalized by a healthcare facility, should the manufacturer make a new declaration?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-28711\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"11\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-28711\"><p>In accordance with Article 87 of the Medical Devices Regulation (MDR) and Article 82 of the In Vitro Diagnostic Medical Devices Regulation (IVDR), the manufacturer must notify the competent authorities concerned via Eudamed or national means (Article 123 of the MDR or Article 113 of the IVDR) of the following incidents:<\/p><p>any serious incident involving devices placed on the European Union market, with the exception of expected side effects that are clearly documented in the product information and quantified in the technical documentation and which are subject to trend reporting under Article 88;<\/p><p>any corrective safety measure taken with regard to devices placed on the Union market, as well as any corrective safety measure taken in a third country concerning a device that is also legally placed on the European Union market, where the reason justifying the measure does not concern exclusively the device placed on the third-country market.<\/p><p>Therefore, when the manufacturer considers that the incident reported to them is a serious incident, they must make a declaration in Eudamed (Article 87, paragraph 11).<\/p><p>Source: <a href=\"https:\/\/ansm.sante.fr\/documents\/reference\/faq-reglement-dm-declaration\">https:\/\/ansm.sante.fr\/documents\/reference\/faq-reglement-dm-declaration<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-28712\" class=\"elementor-tab-title\" data-tab=\"12\" role=\"tab\" aria-controls=\"elementor-tab-content-28712\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">Can a distributor report a serious incident instead of the manufacturer (with the manufacturer's agreement)?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-28712\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"12\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-28712\"><p>No, each operator has their own obligations and responsibilities towards the competent authorities. Manufacturers have reporting obligations regarding post-market surveillance and vigilance. These obligations do not replace those of distributors, and vice versa. Distributors have their own reporting obligations to the competent authorities in situations where a serious risk is identified. The reporting requirements for distributors are set out in Article 14 of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), and those for manufacturers in Articles 10, as well as 87 and 88 (MDR) or 82 and 83 (IVDR).<\/p><p>Source: <a href=\"https:\/\/ansm.sante.fr\/documents\/reference\/faq-reglement-dm-declaration\">https:\/\/ansm.sante.fr\/documents\/reference\/faq-reglement-dm-declaration<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-28713\" class=\"elementor-tab-title\" data-tab=\"13\" role=\"tab\" aria-controls=\"elementor-tab-content-28713\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">Is my software a medical device (DM) or in vitro diagnostic medical device (DMDIV)?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-28713\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"13\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-28713\"><p>The status of the software or application is defined by its intended use and the processing of incoming data.<\/p><p>The intended use, also known as the claim, is determined by the manufacturer (the publisher) of the application. It is described in the instructions, labeling, and promotional material.<br \/>Not all software and applications used in the healthcare field fall under the status of DM or DMDIV. The qualification of software requires a case-by-case evaluation of the intended use and specific characteristics of each to determine the medical purpose of the product.<br \/>Here&#8217;s what to remember:<br \/>To be classified as a DM or DMDIV, the software must meet the following cumulative criteria:<br \/>Be intended for medical purposes as defined by the definition of DM or DMDIV. For example, it should allow for diagnosis, diagnostic assistance, treatment, or treatment assistance.<\/p><p>Provide a result specific to the benefit of a single patient.<br \/>Perform an action on incoming data, such as analysis to provide new medical information. For example, an application for analyzing physiological signal data specific to a patient and with medical alert functions will be classified as a DM. This action must be different from storage, communication, or a simple search such as a database or digital library integrating data for the exclusive purpose of archiving without exploiting them.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-28714\" class=\"elementor-tab-title\" data-tab=\"14\" role=\"tab\" aria-controls=\"elementor-tab-content-28714\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">For example: Adherence software and application - DM or not DM?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-28714\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"14\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-28714\"><p>The purpose of this type of application is to improve adherence to a treatment in a patient, i.e., the correspondence between a patient&#8217;s treatment adherence (e.g., regular medication intake) and the doctor&#8217;s prescription. The patient can track their medication intake and manage reminder settings through their smartphone or email. The software allows for adherence reports to be sent to the treating physician, as well as planning and managing appointments with healthcare professionals.<br \/>Tracking a patient&#8217;s adherence and sending medication reminders does not constitute a medical purpose under Article 2 of Regulation 2017\/745.<\/p><p>Source : <a href=\"https:\/\/ansm.sante.fr\/documents\/reference\/le-logiciel-ou-lapplication-sante-que-je-vais-mettre-sur-le-marche-releve-t-il-du-statut-de-dispositif-medical-dm-ou-de-dispositif-medical-de-diagnostic-in-vitro-dm-div\">https:\/\/ansm.sante.fr\/documents\/reference\/le-logiciel-ou-lapplication-sante-que-je-vais-mettre-sur-le-marche-releve-t-il-du-statut-de-dispositif-medical-dm-ou-de-dispositif-medical-de-diagnostic-in-vitro-dm-div<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-28715\" class=\"elementor-tab-title\" data-tab=\"15\" role=\"tab\" aria-controls=\"elementor-tab-content-28715\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">What are the criteria for classifying a medical device?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-28715\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"15\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-28715\"><p>The criteria for classifying a medical device are:<\/p><ul><li>Its intended purpose<\/li><li>The mode of action on the patient (invasive\/active)<\/li><li>The duration of use<\/li><li>The site of application<\/li><\/ul><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-28716\" class=\"elementor-tab-title\" data-tab=\"16\" role=\"tab\" aria-controls=\"elementor-tab-content-28716\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">What about accessories associated with certain medical devices?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-28716\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"16\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-28716\"><p>Accessories are classified independently of the devices they are associated with.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-28717\" class=\"elementor-tab-title\" data-tab=\"17\" role=\"tab\" aria-controls=\"elementor-tab-content-28717\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">Must medical device labels and instructions be written in French?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-28717\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"17\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-28717\"><p>In accordance with Article R.5211-20 of the French Public Health Code, which transposes point 4 of Article 4 of Directive 93\/42\/EEC and point 4 of Article 4 of Directive 98\/79\/EC into French law, the labeling of a medical device provided to the end user or patient, the accompanying instructions, as well as any other information related to its operation or use must include a version written in French.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-28718\" class=\"elementor-tab-title\" data-tab=\"18\" role=\"tab\" aria-controls=\"elementor-tab-content-28718\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">Can a CE-marked medical device be assigned a new intended use?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-28718\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"18\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-28718\"><p>When an operator wishes to market a CE-marked medical device and assigns it a new intended use in order to market it under their own name, this medical device constitutes a new product and must undergo a new CE marking procedure in compliance with Directive 93\/42\/EEC.<\/p><p>Indeed, in accordance with the definition of the manufacturer provided in paragraph f of Article 1 point 2 of the aforementioned directive, the obligations of the directive that apply to manufacturers also apply to the natural or legal person who assembles, packages, processes, refurbishes and\/or labels one or more prefabricated products and\/or assigns them the intended use of a device in order to place them on the market under their own name.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-28719\" class=\"elementor-tab-title\" data-tab=\"19\" role=\"tab\" aria-controls=\"elementor-tab-content-28719\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">How can I be sure that the confidentiality of the information I will have to provide as part of a quality procedure will be fully respected?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-28719\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"19\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-28719\"><p>The confidentiality of our clients&#8217; data is one of our core values. To ensure we fully meet your needs, we can draft a confidentiality agreement that will apply from the beginning of the project.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-28720\" class=\"elementor-tab-title\" data-tab=\"20\" role=\"tab\" aria-controls=\"elementor-tab-content-28720\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">Which medical devices must be subject to communication when placed on the market in France?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-28720\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"20\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-28720\"><p>In accordance with articles L.5211-4 and R.5211-66 of the French Public Health Code, which transpose article 14 of Directive 93\/42\/CEE into French law, the data identifying Class IIa, IIb, III medical devices and active implantable medical devices must be communicated to the ANSM upon their entry into service on French territory.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-28721\" class=\"elementor-tab-title\" data-tab=\"21\" role=\"tab\" aria-controls=\"elementor-tab-content-28721\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">Can we have multiple training sessions in one day?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-28721\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"21\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-28721\"><p>We can indeed offer &#8220;training packages&#8221; that group several training sessions in the same day, as long as the duration of the selected training sessions does not exceed half a day.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-28722\" class=\"elementor-tab-title\" data-tab=\"22\" role=\"tab\" aria-controls=\"elementor-tab-content-28722\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">How can I know which training is suitable for my needs?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-28722\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"22\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-28722\"><p>We offer a meeting with our sales representatives and trainers in order to better understand your needs for your projects. This way, we can quickly send you a relevant proposal.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-28723\" class=\"elementor-tab-title\" data-tab=\"23\" role=\"tab\" aria-controls=\"elementor-tab-content-28723\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">Where are the trainings held?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-28723\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"23\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-28723\"><p>For in-house training, we can welcome you in our premises or come to your establishment if you wish.<br \/>Inter-company training is organized in our headquarters in Orsay (91), France.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-28724\" class=\"elementor-tab-title\" data-tab=\"24\" role=\"tab\" aria-controls=\"elementor-tab-content-28724\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">Can training be refunded by my OPCO?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-28724\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"24\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-28724\"><p>CEISO is an accredited training organization. Therefore, if you are entitled to training rights, the training we offer can be fully refunded by your OPCO.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-28725\" class=\"elementor-tab-title\" data-tab=\"25\" role=\"tab\" aria-controls=\"elementor-tab-content-28725\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">How does a training day go?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-28725\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"25\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-28725\"><p>A training day usually runs from 9am to 5pm with a lunch break \u2013 a meeting shared with the trainer. However, since each training is different, we invite you to consult our training catalog in which you will find a detailed program for each of them.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-28726\" class=\"elementor-tab-title\" data-tab=\"26\" role=\"tab\" aria-controls=\"elementor-tab-content-28726\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">We will soon be marketing our devices in Taiwan and Japan. Are you competent to accompany us in these areas?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-28726\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"26\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-28726\"><p>In order to be present to help companies wishing to expand their markets, we are competent to accompany you in several areas outside Europe: Asia (China, Japan, Taiwan) but also the Pacific, North America (USA, Canada&#8230;), MEA (Lebanon, Tunisia, Ivory Coast).<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-28727\" class=\"elementor-tab-title\" data-tab=\"27\" role=\"tab\" aria-controls=\"elementor-tab-content-28727\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">How long does such a process take?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-28727\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"27\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-28727\"><p>This depends on several factors:<\/p><ul><li>Senior management, who lead the initiative.<\/li><li>The resources they are willing to allocate to this process, both internally (human resources) and externally (outsourcing some of the work to a specialized firm).<\/li><li>The quality and completeness of the documents presented.<\/li><li>The responsiveness of the competent authorities in different markets.<\/li><li>From several weeks to a few months.<\/li><\/ul><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-28728\" class=\"elementor-tab-title\" data-tab=\"28\" role=\"tab\" aria-controls=\"elementor-tab-content-28728\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">I don't have a CE certificate for my Class I device. Is this normal? What should I do?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-28728\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"28\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-28728\"><p>This situation is common. A CE marking certificate issued by a Notified Body for a Class I device is not required, except for Class I devices with a measuring or sterile function. However, it is essential to establish a Quality Management System for the general organization of the company, according to the requirements of the EN ISO 13485 standard, which you can have certified (voluntary process).<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-28729\" class=\"elementor-tab-title\" data-tab=\"29\" role=\"tab\" aria-controls=\"elementor-tab-content-28729\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">Can a quality assurance certificate justify the CE marking of a medical device?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-28729\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"29\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-28729\"><p>A CE marking certificate attests to the conformity of a device with regulatory requirements. It can only be issued by a Notified Body for a period of three to five years, in accordance with point 11 of Article 11 of Directive 93\/42\/EEC on medical devices.<\/p><p>A quality certificate attests to the conformity of a company&#8217;s general organization and does not alone justify the regulatory conformity of a device. It can be issued by a Notified Body or a Certification Body.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-28730\" class=\"elementor-tab-title\" data-tab=\"30\" role=\"tab\" aria-controls=\"elementor-tab-content-28730\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">How does an internal audit take place?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-28730\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"30\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-28730\"><p>Internal audits, like audits by Notified Bodies or certification bodies, must be conducted by personnel trained in audit practices, according to the principles of a recognized standard.<\/p><p>This standard provides guidance on the principles of auditing, their implementation, as well as the necessary competence of auditors.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-28731\" class=\"elementor-tab-title\" data-tab=\"31\" role=\"tab\" aria-controls=\"elementor-tab-content-28731\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">As part of the implementation of a quality management system, to what extent will the planned activities be detailed in the proposal?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-28731\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"31\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-28731\"><p>In the interest of full transparency, we want our clients to understand our process, even before the project starts. That&#8217;s why, along with your commercial proposal, we provide you with a &#8220;proposal for support in implementing a quality management system.&#8221; This document will present your specifications, the key points of the mission, the details of the intervention steps, as well as a confidentiality clause.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-28732\" class=\"elementor-tab-title\" data-tab=\"32\" role=\"tab\" aria-controls=\"elementor-tab-content-28732\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">How long must a manufacturer keep the administrative data required under Article R.5211-26 of the Public Health Code for a medical device?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-28732\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"32\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-28732\"><p>The duration for the conservation of administrative data mentioned in Article R5211-26 is:<\/p><ul><li>At least 5 years<\/li><li>At least 15 years, after the manufacture of the last unit of the product in the case of implantable devices.<\/li><\/ul><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-28733\" class=\"elementor-tab-title\" data-tab=\"33\" role=\"tab\" aria-controls=\"elementor-tab-content-28733\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">What is a CRO?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-28733\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"33\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-28733\"><p>A CRO \u2013 Contract Research Organization \u2013 is a service provider company specialized in the management of clinical trials. Our clinical department, MediaClin, has CRO status. We offer clinical evaluations adapted to your medical devices and your strategy. The clinical evaluation can be bibliographical or can involve a clinical trial.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-28734\" class=\"elementor-tab-title\" data-tab=\"34\" role=\"tab\" aria-controls=\"elementor-tab-content-28734\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">What is the Research Tax Credit?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-28734\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"34\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-28734\"><p>The Research Tax Credit (CIR) covers our company&#8217;s research activities. It entitles you to a tax reduction.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-28735\" class=\"elementor-tab-title\" data-tab=\"35\" role=\"tab\" aria-controls=\"elementor-tab-content-28735\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">When do we talk about clinical data and clinical evaluation?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-28735\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"35\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-28735\"><p>&#8220;Clinical data&#8221; refers to all safety and\/or performance information generated from the clinical use, in humans, of the medical device.<br \/>The evaluation of clinical data allows for confirmation of compliance with requirements regarding the characteristics and performance of the device under its normal conditions of use, as well as the evaluation of adverse effects and the acceptability of the benefit\/risk ratio. It enables compliance with the Essential Requirements of European Directives.<\/p><p>Clinical evaluation includes:<\/p><ul><li>scientific literature reviews (bibliographies)<\/li><li>clinical investigations (pre-marketing or post-marketing, reimbursement, etc.)<\/li><\/ul><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-accordion-item\">\n\t\t\t\t\t<div id=\"elementor-tab-title-28736\" class=\"elementor-tab-title\" data-tab=\"36\" role=\"tab\" aria-controls=\"elementor-tab-content-28736\" aria-expanded=\"false\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon elementor-accordion-icon-right\" aria-hidden=\"true\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-closed\"><i class=\"fas fa-plus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t<span class=\"elementor-accordion-icon-opened\"><i class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t<a class=\"elementor-accordion-title\" href=\"\">How do we know which clinical evaluation is required for our product?<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<div id=\"elementor-tab-content-28736\" class=\"elementor-tab-content elementor-clearfix\" data-tab=\"36\" role=\"tabpanel\" aria-labelledby=\"elementor-tab-title-28736\"><p>We offer a meeting with our account managers to best target your needs for your projects. This way, we can quickly send you a relevant proposal.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t\t\t<script type=\"application\/ld+json\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"Fake item\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"\"}},{\"@type\":\"Question\",\"name\":\"What is the European Nomenclature for Medical Devices?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>The European Medical Device Nomenclature (EMDN) aims to support the functioning of the European database on medical devices (EUDAMED) in accordance with Article 26 of Regulation (EU) 2017\\\/745 on medical devices (MDR) and Article 23 of Regulation (EU) 2017\\\/746 on in vitro diagnostic medical devices (IVDR). Among its various uses, it will be used by manufacturers for the registration of medical devices in EUDAMED, where it will be associated with each unique device identifier (UDI-DI).<\\\/p><p>As the EMDN serves mainly regulatory purposes to support MDR and IVDR requirements, it also plays a key role in the documentation and technical documentation of MDR\\\/IVDR devices, the sampling of technical documentation performed by notified bodies, post-market surveillance, vigilance, and post-market data analysis, etc. It is intended to support all actors in their activities under the MDR\\\/IVDR and provides patients with key descriptions of devices regarding their own devices and all other devices available on the market and registered in EUDAMED.<\\\/p><p>The EMDN is accessible and downloadable in pdf and excel format by following this link: <a href=\\\"https:\\\/\\\/webgate.ec.europa.eu\\\/dyna2\\\/emdn\\\/\\\">webgate.ec.europa.eu\\\/dyna2\\\/emdn<\\\/a><\\\/p><p>Source :\\u00a0<a href=\\\"https:\\\/\\\/eu-udi.zendesk.com\\\/hc\\\/fr\\\/articles\\\/360020878877-Qu-est-ce-que-la-nomenclature-europ%C3%A9enne-des-dispositifs-m%C3%A9dicaux-\\\">https:\\\/\\\/eu-udi.zendesk.com\\\/hc\\\/fr\\\/articles\\\/360020878877-Qu-est-ce-que-la-nomenclature-europ%C3%A9enne-des-dispositifs-m%C3%A9dicaux-<\\\/a><\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"What is a \\\"basic UDI-ID\\\"?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<div class=\\\"cmsms_toggle\\\"><div class=\\\"cmsms_toggle_inner\\\"><p>The &#8220;Basic UDI-DI&#8221; is the main access key to information about devices in the Eudamed database. It is referenced in relevant documentation [such as certificates (including the free sale certificate), the EU Declaration of Conformity, technical documentation, and the Summary of Safety and Clinical Performance].<\\\/p><p>It is intended to identify and connect devices with the same intended purpose, risk class, and essential design and manufacturing characteristics.<\\\/p><p>It is independent\\\/separate from the device packaging\\\/labeling and does not appear on any commercial item. Any Basic UDI-DI must uniquely identify the devices (group) covered by this Basic UDI-DI.<\\\/p><p>The Basic UDI-DI is the high-level grouping for devices having:<\\\/p><ul><li>the same intended purpose<\\\/li><li>same manufacturer<\\\/li><li>same attributes<\\\/li><li>essential<\\\/li><li>characteristics<\\\/li><\\\/ul><p>\\u00a0<\\\/p><p>Source: <a href=\\\"https:\\\/\\\/eu-udi.zendesk.com\\\/hc\\\/fr\\\/sections\\\/360005306717-Questions-fr%C3%A9quemment-pos%C3%A9es\\\">https:\\\/\\\/eu-udi.zendesk.com\\\/hc\\\/fr\\\/sections\\\/360005306717-Questions-fr%C3%A9quemment-pos%C3%A9es<\\\/a><\\\/p><\\\/div><\\\/div>\"}},{\"@type\":\"Question\",\"name\":\"If a device is sold exclusively in a retail store, is the IUD-IP information required to be provided in AIDC format?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<div class=\\\"cmsms_toggle\\\"><div class=\\\"cmsms_toggle_inner\\\"><p>The IUD-IP information is not required to appear in AIDC format on the retail store packaging label if the device is sold exclusively in a retail store. The MDR 2017\\\/745 excludes IUD-IP information from AIDC format at the retail store packaging level; however, the exception does not apply to the HRI, which must be identified on the retail store packaging. The mentioned exception is defined for the sales packaging level only, so the primary packaging level must comply with the IUD requirements as defined in the MDR (IUD-ID and IUD-IP in AIDC and HRI formats).<\\\/p><p>Source: Frequently Asked Questions \\u2013 Unique Device Identification (UDI) Helpdesk <a href=\\\"https:\\\/\\\/eu-udi.zendesk.com\\\/hc\\\/en\\\">https:\\\/\\\/eu-udi.zendesk.com\\\/hc\\\/en<\\\/a> &#8211; UDI FAQ Factsheet (2022)<\\\/p><\\\/div><\\\/div>\"}},{\"@type\":\"Question\",\"name\":\"What is the difference between the IUD unit of use and IUD-ID?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<div class=\\\"cmsms_toggle\\\"><div class=\\\"cmsms_toggle_inner\\\"><p>The IUD-ID is a unique numeric or alphanumeric code specific to a device model and is also used as a &#8220;key&#8221; to access information stored in an IUD database. The IUD-ID must be unique at each level of device packaging.<\\\/p><p>This mandatory and fixed part of an IUD identifies the specific product and packaging configuration of a manufacturer.<\\\/p><p>The Device Identifier (UoU DI) is an identifier (following the IUD rules of the chosen issuing entity) assigned to an individual medical device when an IUD is not labeled on the individual device at the unit of use level. Its purpose is to provide an IUD-ID to identify a device used on a patient when an IUD-ID does not appear on the device label.<\\\/p><p>For example: if the lowest basic packaging level with an identified IUD has a number of devices greater than 1, a UoU DI must be assigned.<\\\/p><p>If the device is not directly labeled and the basic quantity of the device is more than one, the UoU ID must be provided in EUDAMED.<\\\/p><p>The issuing entity of the UoU DI code is the same as the IUD-ID.<\\\/p><p>The same UoU DI can be used for multiple devices.<\\\/p><p>According to Annex VI, Part C, Section 1, the UoU-DI is defined as follows:<\\\/p><p>The UoU DI is used to associate the use of a device with a patient in cases where an IUD is not placed on the individual device at the unit of use level, for example when multiple units of the same device are packaged together.<\\\/p><p>Source : Frequently Asked Questions \\u2013 Unique Device Identification (UDI) Helpdesk<br \\\/><a href=\\\"https:\\\/\\\/eu-udi.zendesk.com\\\/hc\\\/fr\\\">https:\\\/\\\/eu-udi.zendesk.com\\\/hc\\\/fr<\\\/a> \\u2013 UDI FAQ Factsheet (2022)<\\\/p><\\\/div><\\\/div>\"}},{\"@type\":\"Question\",\"name\":\"If a device is sold exclusively in a retail point of sale, must IUD-IP information be provided in AIDC format?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>IUD-IP information is not required to appear on the AIDC label on the retail packaging if the device is sold exclusively at a retail point of sale. The MDR 2017\\\/745 excludes IUD-IP information from the AIDC format at the point of sale packaging level, however, the exception does not apply to the HRI, which must be identified on the point of sale packaging. The mentioned exception is defined for the sales packaging level only, so the primary packaging level must comply with the IUD requirements as defined in the MDR (IUD-ID and IUD-IP in AIDC and HRI formats).*<\\\/p><p>Source: Frequently Asked Questions &#8211; Unique Device Identification (UDI) Helpdesk<br \\\/><a href=\\\"https:\\\/\\\/eu-udi.zendesk.com\\\/hc\\\/fr\\\">https:\\\/\\\/eu-udi.zendesk.com\\\/hc\\\/fr<\\\/a> &#8211; UDI FAQ Factsheet (2022)<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"What is the difference between the UDI and UDI-DI?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>The UDI-DI is a unique numerical or alphanumeric code specific to a device model and is also used as an &#8220;access key&#8221; to information stored in a UDI database. The UDI-DI must be unique at each level of device packaging.<\\\/p><p>This mandatory and fixed part of a UDI identifies the specific product and packaging configuration of a manufacturer.<\\\/p><p>The UDI-DI is assigned to an individual medical device when a UDI is not labeled on the individual device at the level of its unit of use. Its purpose is to provide a UDI-DI to identify a device used on a patient when a UDI-DI does not appear on the device label.<\\\/p><p><br \\\/>For example: if the lowest basic packaging level with an identified UDI has a device number greater than 1, a UDI-DI must be assigned.<\\\/p><p>If the device is not directly marked and the basic quantity of the device is greater than one, the UDI-DI must be provided in EUDAMED.<\\\/p><p>The issuer of the UDI-DI unit code is the same as the UDI-DI.<\\\/p><p>The same UDI-DI can be used for multiple devices.<\\\/p><p>In accordance with Annex VI, Part C, Section 1, the UDI-DI is defined as follows: The UDI-DI is used to associate the use of a device with a patient in cases where a UDI is not placed on the individual device at the level of its unit of use, for example, when multiple units of the same device are packaged together. *<\\\/p><p>Source: Frequently Asked Questions &#8211; Unique Device Identification (UDI) Helpdesk <a href=\\\"https:\\\/\\\/eu-udi.zendesk.com\\\/hc\\\/en\\\">https:\\\/\\\/eu-udi.zendesk.com\\\/hc\\\/en<\\\/a> &#8211; UDI FAQ Factsheet (2022)<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"How should an IUD appear on the label or packaging of a device?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>The IUD support (Automatic Identification and Data Capture (AIDC) and Human Readable Interpretation (HRI) of the IUD) must be present on the label or on the device itself and on all higher levels of the device&#8217;s packaging.<\\\/p><p>If there are significant space constraints on the unit packaging, the IUD support may be placed at the higher packaging level.<\\\/p><p>The higher packaging levels must have their own unique IUD. Please note that shipping containers will be exempt from this requirement.<\\\/p><p>The IUD must appear in a plain text\\\/human-readable information (HRI) version and in a form that uses AIDC technology. AIDC refers to any technology that transmits the unique device identifier or device identifier of a device in a form that can be entered into an electronic patient record or other computer system via an automated process. The HRI consists of readable characters that can be easily read by people.<\\\/p><p>If there are significant constraints on the use of both AIDC and HRI on the label, only the AIDC format must appear on the label.<\\\/p><p>For devices intended for use outside of healthcare facilities, such as home care devices, HRI must appear on the label even if it results in no room for AIDC.<\\\/p><p>For other specific requirements related to the IUD support, please refer to section 4 of Annex VI, Part C, of the two regulations.<\\\/p><p>For single-use medical devices of class I and IIa medical devices and Class A and Class B IVD medical devices that are individually packaged and labeled, the IUD support is not required to appear on the packaging, but it must appear on a higher packaging level, such as a carton containing multiple devices (individually packaged). However, when the healthcare provider is not expected to have access, in cases such as home care, to the higher packaging level of the device, the IUD must be placed on the packaging (of the individual device).<\\\/p><p>For devices exclusively intended for retail sale, AIDC IUD-IPs are not required to appear on the point-of-sale packaging.<\\\/p><p>If the IUD support is easily readable or, in the case of AIDC, scannable, through the device&#8217;s packaging, the placement of the IUD support on the packaging is not required.<\\\/p><p>Source : Unique Device Identification (UDI) System under the EU medical devices Regulations 2017\\\/745 and 2017\\\/74601\\\/08\\\/2020<\\\/p><p><a href=\\\"https:\\\/\\\/health.ec.europa.eu\\\/medical-devices-topics-interest\\\/unique-device-identifier-udi_fr\\\">https:\\\/\\\/health.ec.europa.eu\\\/medical-devices-topics-interest\\\/unique-device-identifier-udi_fr<\\\/a> \\u2013 FAQ relative au syst\\u00e8me IUD<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"What are the obligations for appointing a medical device vigilance correspondent for manufacturers\\\/importers\\\/distributors?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>Currently, article R. 5212-13 of the French Public Health Code (CSP) stipulates that any manufacturer of medical devices, or their representative, must appoint a medical device vigilance correspondent and communicate their name to the Director General of ANSM.<\\\/p><p>This provision is subject to change with the forthcoming publication of the implementing decrees of the DM and DMDIV ordinances. However, if maintained, it will continue not to apply to distributors or importers.<\\\/p><p>Source: <a href=\\\"https:\\\/\\\/ansm.sante.fr\\\/documents\\\/reference\\\/faq-reglement-dm-divers#correspondant_vigilance\\\">https:\\\/\\\/ansm.sante.fr\\\/documents\\\/reference\\\/faq-reglement-dm-divers#correspondant_vigilance<\\\/a><\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"Are medical biology and anatomopathology laboratories required to have a local \\u201creactovigilance\\u201d correspondent?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>Article R. 5222-10 of the Public Health Code states that any health cooperation user of in vitro diagnostic medical devices, healthcare professionals, manufacturers or their representatives, importers and distributors, as well as any blood transfusion establishment, must declare a local \\u201creactovigilance\\u201d correspondent to the ANSM. This provision includes medical biology and anatomopathology laboratories.<\\\/p><p>This provision may be subject to change with the upcoming publication of the DM and DMDIV ordinances.<\\\/p><p>Source: <a href=\\\"https:\\\/\\\/ansm.sante.fr\\\/documents\\\/reference\\\/faq-reglement-dm-divers#correspondant_vigilance\\\">https:\\\/\\\/ansm.sante.fr\\\/documents\\\/reference\\\/faq-reglement-dm-divers#correspondant_vigilance<\\\/a><\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"If a manufacturer is informed by the ANSM of the declaration of an incident formalized by a healthcare facility, should the manufacturer make a new declaration?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>In accordance with Article 87 of the Medical Devices Regulation (MDR) and Article 82 of the In Vitro Diagnostic Medical Devices Regulation (IVDR), the manufacturer must notify the competent authorities concerned via Eudamed or national means (Article 123 of the MDR or Article 113 of the IVDR) of the following incidents:<\\\/p><p>any serious incident involving devices placed on the European Union market, with the exception of expected side effects that are clearly documented in the product information and quantified in the technical documentation and which are subject to trend reporting under Article 88;<\\\/p><p>any corrective safety measure taken with regard to devices placed on the Union market, as well as any corrective safety measure taken in a third country concerning a device that is also legally placed on the European Union market, where the reason justifying the measure does not concern exclusively the device placed on the third-country market.<\\\/p><p>Therefore, when the manufacturer considers that the incident reported to them is a serious incident, they must make a declaration in Eudamed (Article 87, paragraph 11).<\\\/p><p>Source: <a href=\\\"https:\\\/\\\/ansm.sante.fr\\\/documents\\\/reference\\\/faq-reglement-dm-declaration\\\">https:\\\/\\\/ansm.sante.fr\\\/documents\\\/reference\\\/faq-reglement-dm-declaration<\\\/a><\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"Can a distributor report a serious incident instead of the manufacturer (with the manufacturer's agreement)?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>No, each operator has their own obligations and responsibilities towards the competent authorities. Manufacturers have reporting obligations regarding post-market surveillance and vigilance. These obligations do not replace those of distributors, and vice versa. Distributors have their own reporting obligations to the competent authorities in situations where a serious risk is identified. The reporting requirements for distributors are set out in Article 14 of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), and those for manufacturers in Articles 10, as well as 87 and 88 (MDR) or 82 and 83 (IVDR).<\\\/p><p>Source: <a href=\\\"https:\\\/\\\/ansm.sante.fr\\\/documents\\\/reference\\\/faq-reglement-dm-declaration\\\">https:\\\/\\\/ansm.sante.fr\\\/documents\\\/reference\\\/faq-reglement-dm-declaration<\\\/a><\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"Is my software a medical device (DM) or in vitro diagnostic medical device (DMDIV)?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>The status of the software or application is defined by its intended use and the processing of incoming data.<\\\/p><p>The intended use, also known as the claim, is determined by the manufacturer (the publisher) of the application. It is described in the instructions, labeling, and promotional material.<br \\\/>Not all software and applications used in the healthcare field fall under the status of DM or DMDIV. The qualification of software requires a case-by-case evaluation of the intended use and specific characteristics of each to determine the medical purpose of the product.<br \\\/>Here&#8217;s what to remember:<br \\\/>To be classified as a DM or DMDIV, the software must meet the following cumulative criteria:<br \\\/>Be intended for medical purposes as defined by the definition of DM or DMDIV. For example, it should allow for diagnosis, diagnostic assistance, treatment, or treatment assistance.<\\\/p><p>Provide a result specific to the benefit of a single patient.<br \\\/>Perform an action on incoming data, such as analysis to provide new medical information. For example, an application for analyzing physiological signal data specific to a patient and with medical alert functions will be classified as a DM. This action must be different from storage, communication, or a simple search such as a database or digital library integrating data for the exclusive purpose of archiving without exploiting them.<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"For example: Adherence software and application - DM or not DM?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>The purpose of this type of application is to improve adherence to a treatment in a patient, i.e., the correspondence between a patient&#8217;s treatment adherence (e.g., regular medication intake) and the doctor&#8217;s prescription. The patient can track their medication intake and manage reminder settings through their smartphone or email. The software allows for adherence reports to be sent to the treating physician, as well as planning and managing appointments with healthcare professionals.<br \\\/>Tracking a patient&#8217;s adherence and sending medication reminders does not constitute a medical purpose under Article 2 of Regulation 2017\\\/745.<\\\/p><p>Source : <a href=\\\"https:\\\/\\\/ansm.sante.fr\\\/documents\\\/reference\\\/le-logiciel-ou-lapplication-sante-que-je-vais-mettre-sur-le-marche-releve-t-il-du-statut-de-dispositif-medical-dm-ou-de-dispositif-medical-de-diagnostic-in-vitro-dm-div\\\">https:\\\/\\\/ansm.sante.fr\\\/documents\\\/reference\\\/le-logiciel-ou-lapplication-sante-que-je-vais-mettre-sur-le-marche-releve-t-il-du-statut-de-dispositif-medical-dm-ou-de-dispositif-medical-de-diagnostic-in-vitro-dm-div<\\\/a><\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"What are the criteria for classifying a medical device?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>The criteria for classifying a medical device are:<\\\/p><ul><li>Its intended purpose<\\\/li><li>The mode of action on the patient (invasive\\\/active)<\\\/li><li>The duration of use<\\\/li><li>The site of application<\\\/li><\\\/ul>\"}},{\"@type\":\"Question\",\"name\":\"What about accessories associated with certain medical devices?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>Accessories are classified independently of the devices they are associated with.<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"Must medical device labels and instructions be written in French?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>In accordance with Article R.5211-20 of the French Public Health Code, which transposes point 4 of Article 4 of Directive 93\\\/42\\\/EEC and point 4 of Article 4 of Directive 98\\\/79\\\/EC into French law, the labeling of a medical device provided to the end user or patient, the accompanying instructions, as well as any other information related to its operation or use must include a version written in French.<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"Can a CE-marked medical device be assigned a new intended use?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>When an operator wishes to market a CE-marked medical device and assigns it a new intended use in order to market it under their own name, this medical device constitutes a new product and must undergo a new CE marking procedure in compliance with Directive 93\\\/42\\\/EEC.<\\\/p><p>Indeed, in accordance with the definition of the manufacturer provided in paragraph f of Article 1 point 2 of the aforementioned directive, the obligations of the directive that apply to manufacturers also apply to the natural or legal person who assembles, packages, processes, refurbishes and\\\/or labels one or more prefabricated products and\\\/or assigns them the intended use of a device in order to place them on the market under their own name.<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"How can I be sure that the confidentiality of the information I will have to provide as part of a quality procedure will be fully respected?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>The confidentiality of our clients&#8217; data is one of our core values. To ensure we fully meet your needs, we can draft a confidentiality agreement that will apply from the beginning of the project.<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"Which medical devices must be subject to communication when placed on the market in France?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>In accordance with articles L.5211-4 and R.5211-66 of the French Public Health Code, which transpose article 14 of Directive 93\\\/42\\\/CEE into French law, the data identifying Class IIa, IIb, III medical devices and active implantable medical devices must be communicated to the ANSM upon their entry into service on French territory.<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"Can we have multiple training sessions in one day?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>We can indeed offer &#8220;training packages&#8221; that group several training sessions in the same day, as long as the duration of the selected training sessions does not exceed half a day.<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"How can I know which training is suitable for my needs?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>We offer a meeting with our sales representatives and trainers in order to better understand your needs for your projects. This way, we can quickly send you a relevant proposal.<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"Where are the trainings held?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>For in-house training, we can welcome you in our premises or come to your establishment if you wish.<br \\\/>Inter-company training is organized in our headquarters in Orsay (91), France.<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"Can training be refunded by my OPCO?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>CEISO is an accredited training organization. Therefore, if you are entitled to training rights, the training we offer can be fully refunded by your OPCO.<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"How does a training day go?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>A training day usually runs from 9am to 5pm with a lunch break \\u2013 a meeting shared with the trainer. However, since each training is different, we invite you to consult our training catalog in which you will find a detailed program for each of them.<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"We will soon be marketing our devices in Taiwan and Japan. Are you competent to accompany us in these areas?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>In order to be present to help companies wishing to expand their markets, we are competent to accompany you in several areas outside Europe: Asia (China, Japan, Taiwan) but also the Pacific, North America (USA, Canada&#8230;), MEA (Lebanon, Tunisia, Ivory Coast).<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"How long does such a process take?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>This depends on several factors:<\\\/p><ul><li>Senior management, who lead the initiative.<\\\/li><li>The resources they are willing to allocate to this process, both internally (human resources) and externally (outsourcing some of the work to a specialized firm).<\\\/li><li>The quality and completeness of the documents presented.<\\\/li><li>The responsiveness of the competent authorities in different markets.<\\\/li><li>From several weeks to a few months.<\\\/li><\\\/ul>\"}},{\"@type\":\"Question\",\"name\":\"I don't have a CE certificate for my Class I device. Is this normal? What should I do?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>This situation is common. A CE marking certificate issued by a Notified Body for a Class I device is not required, except for Class I devices with a measuring or sterile function. However, it is essential to establish a Quality Management System for the general organization of the company, according to the requirements of the EN ISO 13485 standard, which you can have certified (voluntary process).<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"Can a quality assurance certificate justify the CE marking of a medical device?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>A CE marking certificate attests to the conformity of a device with regulatory requirements. It can only be issued by a Notified Body for a period of three to five years, in accordance with point 11 of Article 11 of Directive 93\\\/42\\\/EEC on medical devices.<\\\/p><p>A quality certificate attests to the conformity of a company&#8217;s general organization and does not alone justify the regulatory conformity of a device. It can be issued by a Notified Body or a Certification Body.<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"How does an internal audit take place?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>Internal audits, like audits by Notified Bodies or certification bodies, must be conducted by personnel trained in audit practices, according to the principles of a recognized standard.<\\\/p><p>This standard provides guidance on the principles of auditing, their implementation, as well as the necessary competence of auditors.<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"As part of the implementation of a quality management system, to what extent will the planned activities be detailed in the proposal?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>In the interest of full transparency, we want our clients to understand our process, even before the project starts. That&#8217;s why, along with your commercial proposal, we provide you with a &#8220;proposal for support in implementing a quality management system.&#8221; This document will present your specifications, the key points of the mission, the details of the intervention steps, as well as a confidentiality clause.<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"How long must a manufacturer keep the administrative data required under Article R.5211-26 of the Public Health Code for a medical device?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>The duration for the conservation of administrative data mentioned in Article R5211-26 is:<\\\/p><ul><li>At least 5 years<\\\/li><li>At least 15 years, after the manufacture of the last unit of the product in the case of implantable devices.<\\\/li><\\\/ul>\"}},{\"@type\":\"Question\",\"name\":\"What is a CRO?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>A CRO \\u2013 Contract Research Organization \\u2013 is a service provider company specialized in the management of clinical trials. Our clinical department, MediaClin, has CRO status. We offer clinical evaluations adapted to your medical devices and your strategy. The clinical evaluation can be bibliographical or can involve a clinical trial.<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"What is the Research Tax Credit?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>The Research Tax Credit (CIR) covers our company&#8217;s research activities. It entitles you to a tax reduction.<\\\/p>\"}},{\"@type\":\"Question\",\"name\":\"When do we talk about clinical data and clinical evaluation?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>&#8220;Clinical data&#8221; refers to all safety and\\\/or performance information generated from the clinical use, in humans, of the medical device.<br \\\/>The evaluation of clinical data allows for confirmation of compliance with requirements regarding the characteristics and performance of the device under its normal conditions of use, as well as the evaluation of adverse effects and the acceptability of the benefit\\\/risk ratio. It enables compliance with the Essential Requirements of European Directives.<\\\/p><p>Clinical evaluation includes:<\\\/p><ul><li>scientific literature reviews (bibliographies)<\\\/li><li>clinical investigations (pre-marketing or post-marketing, reimbursement, etc.)<\\\/li><\\\/ul>\"}},{\"@type\":\"Question\",\"name\":\"How do we know which clinical evaluation is required for our product?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p>We offer a meeting with our account managers to best target your needs for your projects. This way, we can quickly send you a relevant proposal.<\\\/p>\"}}]}<\/script>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8e37ab6 elementor-widget elementor-widget-text-editor\" data-id=\"8e37ab6\" data-element_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<p>Other questions ? <a href=\"\/en\/contact\">Contact us<\/a>.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-60ad87e\" data-id=\"60ad87e\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-2af3a58 elementor-widget elementor-widget-image\" data-id=\"2af3a58\" data-element_type=\"widget\" data-settings=\"{&quot;sticky&quot;:&quot;top&quot;,&quot;sticky_on&quot;:[&quot;desktop&quot;],&quot;sticky_offset&quot;:112,&quot;sticky_parent&quot;:&quot;yes&quot;,&quot;sticky_effects_offset&quot;:0}\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.12.2 - 23-04-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"800\" height=\"800\" src=\"https:\/\/ceiso.fr\/en\/wp-content\/uploads\/sites\/2\/2023\/04\/CEISO-FAQ.png\" class=\"attachment-large size-large wp-image-189\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/ceiso.fr\/en\/wp-content\/uploads\/sites\/2\/2023\/04\/CEISO-FAQ.png 1024w, https:\/\/ceiso.fr\/en\/wp-content\/uploads\/sites\/2\/2023\/04\/CEISO-FAQ-300x300.png 300w, https:\/\/ceiso.fr\/en\/wp-content\/uploads\/sites\/2\/2023\/04\/CEISO-FAQ-150x150.png 150w, https:\/\/ceiso.fr\/en\/wp-content\/uploads\/sites\/2\/2023\/04\/CEISO-FAQ-768x768.png 768w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Questions\/answers If you can&#8217;t find what you are looking for, please contact us. Fake item What is the European Nomenclature for Medical Devices? The European Medical Device Nomenclature (EMDN) aims to support the functioning of the European database on medical devices (EUDAMED) in accordance with Article 26 of Regulation (EU) 2017\/745 on medical devices (MDR) [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/pages\/187"}],"collection":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/comments?post=187"}],"version-history":[{"count":22,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/pages\/187\/revisions"}],"predecessor-version":[{"id":1119,"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/pages\/187\/revisions\/1119"}],"wp:attachment":[{"href":"https:\/\/ceiso.fr\/en\/wp-json\/wp\/v2\/media?parent=187"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}