{"id":13302,"date":"2023-07-31T11:37:32","date_gmt":"2023-07-31T11:37:32","guid":{"rendered":"https:\/\/www.icemedics.com\/ce-development\/"},"modified":"2023-10-10T07:37:42","modified_gmt":"2023-10-10T07:37:42","slug":"ce-development","status":"publish","type":"page","link":"https:\/\/www.icemedics.com\/en\/ce-development\/","title":{"rendered":"CE Development"},"content":{"rendered":"

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CE Development<\/h1>\n

Unique Device Identification (UDI)<\/h2>\n

It is a unique numerical or alphanumeric code related to a medical device. This enables clear and unambiguous identification of specific products in the market and facilitates their traceability.<\/p>\n

The UDI includes the following components:<\/p>\n

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  • a product identifier (UDI-DI)<\/li>\n
  • a production identifier (UDI-PI).<\/li>\n<\/ul>\n

    These allow access to useful product information. The specificity of the UDI:<\/p>\n

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    • increases product traceability efficiency<\/li>\n
    • facilitates product retrieval<\/li>\n
    • prevents counterfeiting (MDR Article 123(3)(f), Article 27(4))<\/li>\n
    • enhances patient safety.<\/li>\n<\/ul>\n

      The basic UDI-DI is the main element in the database and relevant documentation (e.g., certificates, declarations of conformity, technical documentation, and summary of safety and clinical performance) and will also be the key to accessing information related to products entered in the future European database of medical devices.<\/p>\n

      The new UDI system will facilitate the traceability of medical devices. Concurrently, post-market activities related to product safety will also be more robust and allow for better monitoring by competent authorities.<\/p>\n

      The mandatory use of the UDI system will begin on May 26, 2025 (MDR ARTICLE 123(3)(F), ARTICLE 27(4))<\/p>\n

      Article 27 of Regulation 2017\/745 and Article 24 of Regulation 746\/2017 establish that the UDI system will consist of:<\/p>\n

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      • The creation of a UDI that includes a product identifier (“UDI-DI”), specific to a manufacturer and a product, allowing access to information, as well as a production identifier (“UDI-PI”) identifying the production unit of the product and, where applicable, the packaged products; Placing the UDI on the product label or packaging;<\/li>\n
      • Storage of the UDI by economic operators, healthcare facilities, and healthcare professionals.<\/li>\n
      • O armazenamento da UDI pelos agentes econ\u00f3micos, centros de sa\u00fade e profissionais de sa\u00fade.<\/li>\n
      • Creation of an electronic unique product identification system (“UDI database”).<\/li>\n<\/ul>\n

        Disposable gloves can be:<\/p>\n

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        • Category I<\/li>\n
        • Category I medical<\/li>\n
        • Category III – PPE<\/li>\n
        • Dual: Category I medical and III<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n

          [\/et_pb_text][et_pb_image src=”https:\/\/www.icemedics.com\/wp-content\/uploads\/2023\/10\/CE_CATIII-1.gif” _builder_version=”4.18.0″ _module_preset=”default” hover_enabled=”0″ sticky_enabled=”0″][\/et_pb_image][et_pb_image src=”https:\/\/www.icemedics.com\/wp-content\/uploads\/2023\/10\/CE_MD.gif” _builder_version=”4.18.0″ _module_preset=”default” hover_enabled=”0″ sticky_enabled=”0″][\/et_pb_image][et_pb_text _builder_version=”4.18.0″ _module_preset=”ae5aa582-94d6-481c-bc07-2d210ff09536″ text_font=”Source Sans Pro||||||||” text_text_color=”#000000″ text_font_size=”16px” header_font=”Heebo|700|||||||” header_text_align=”left” header_text_color=”#ff9900″ header_font_size=”45px” header_2_font=”Source Sans Pro|700|||||||” header_2_text_align=”left” header_2_text_color=”#ff9900″ header_2_font_size=”40px” background_enable_color=”off” use_background_color_gradient=”off” text_orientation=”justified” hover_enabled=”0″ header_text_shadow_style=”preset2″ header_text_shadow_horizontal_length=”0.04em” header_text_shadow_vertical_length=”0.03em” header_text_shadow_color=”rgba(10,10,10,0.13)” header_2_text_shadow_style=”preset2″ header_2_text_shadow_horizontal_length=”0.04em” header_2_text_shadow_vertical_length=”0.03em” header_2_text_shadow_color=”rgba(10,10,10,0.13)” global_colors_info=”{}” sticky_enabled=”0″ custom_margin=”||0px||false|false” custom_padding=”20px||||false|false”]<\/p>\n

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          Certifications for product quality.<\/h2>\n

           <\/p>\n<\/div>\n<\/div>\n<\/div>\n

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          CE Development Unique Device Identification (UDI) It is a unique numerical or alphanumeric code related to a medical device. This enables clear and unambiguous identification of specific products in the market and facilitates their traceability. The UDI includes the following components: a product identifier (UDI-DI) a production identifier (UDI-PI). These allow access to useful product […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"class_list":["post-13302","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.icemedics.com\/en\/wp-json\/wp\/v2\/pages\/13302","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.icemedics.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.icemedics.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.icemedics.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.icemedics.com\/en\/wp-json\/wp\/v2\/comments?post=13302"}],"version-history":[{"count":0,"href":"https:\/\/www.icemedics.com\/en\/wp-json\/wp\/v2\/pages\/13302\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.icemedics.com\/en\/wp-json\/wp\/v2\/media?parent=13302"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}