{"id":23110,"date":"2024-06-10T12:49:41","date_gmt":"2024-06-10T10:49:41","guid":{"rendered":"https:\/\/www.koenigsee-implantate.de\/medical-device-regulation\/"},"modified":"2025-05-05T12:41:50","modified_gmt":"2025-05-05T10:41:50","slug":"medical-device-regulation","status":"publish","type":"post","link":"https:\/\/www.koenigsee-implantate.de\/en\/medical-device-regulation\/","title":{"rendered":"MEDICAL DEVICE REGULATION"},"content":{"rendered":"

[et_pb_section fb_built=”1″ custom_padding_last_edited=”on|tablet” admin_label=”News Header” _builder_version=”4.25.0″ _module_preset=”default” background_image=”https:\/\/www.koenigsee-implantate.de\/wp-content\/uploads\/2023\/01\/koenigsee-Implantate-steril-\u00a9marcelmende-0099.png” parallax=”on” transform_scale=”70%|70%” custom_padding=”24%|25.1%|24%|25.1%|true|true” custom_padding_tablet=”12%|25%|12%|25%|true|true” custom_padding_phone=”22%||22%||true|true” bottom_divider_style=”wave2″ bottom_divider_color=”#FFFFFF” bottom_divider_arrangement=”above_content” locked=”off” global_colors_info=”{}”][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Breadcrumb Navigation” _builder_version=”4.19.4″ _module_preset=”default” custom_margin=”||||false|false” custom_margin_tablet=”||||false|false” custom_margin_phone=”||||false|false” custom_margin_last_edited=”on|phone” custom_padding=”0px|0px|0px|0px|false|false” locked=”off” global_colors_info=”{}”][et_pb_row disabled_on=”on|off|off” _builder_version=”4.16″ _module_preset=”default” custom_margin=”||0px||false|false” custom_padding=”||0px||false|false” locked=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” custom_padding=”0px||0px||false|false” global_colors_info=”{}”][dipl_button inline_buttons=”on” _builder_version=”4.21.0″ _module_preset=”default” custom_margin=”||-2px||false|false” global_colors_info=”{}”][dipl_button_item button_text=”Home” button_url=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjE3In19@” button_use_icon=”on” button_icon=”^||divi||400″ button_icon_color=”#D8E9ED” button_on_hover=”off” button_custom_margin=”0px|-12px|0px|0px|false|false” button_custom_padding=”0px||0px|0px|false|false” _builder_version=”4.16″ _dynamic_attributes=”button_url” _module_preset=”default” button_text_color=”#73B1BD” button_font_size=”22px” global_colors_info=”{}” button_text_color__hover_enabled=”on|hover” button_text_color__hover=”#006F81″][\/dipl_button_item][dipl_button_item button_text=”News & Stories” button_url=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjM3OTYifX0=@” button_use_icon=”on” button_icon=”^||divi||400″ button_icon_color=”#D8E9ED” button_on_hover=”off” button_custom_margin=”0px|-12px|0px||false|false” button_custom_padding=”0px||0px||false|false” _builder_version=”4.21.0″ _dynamic_attributes=”button_url” _module_preset=”default” button_text_color=”#73B1BD” button_font_size=”22px” global_colors_info=”{}” button_text_color__hover_enabled=”on|hover” button_text_color__hover=”#006F81″][\/dipl_button_item][dipl_button_item button_text=”@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IiIsImFmdGVyIjoiIn19@” button_custom_margin=”0px||0px||false|false” button_custom_padding=”0px||0px||false|false” _builder_version=”4.19.4″ _dynamic_attributes=”button_text” _module_preset=”default” button_font_size=”22px” global_colors_info=”{}”][\/dipl_button_item][\/dipl_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Titel und Datum” _builder_version=”4.19.4″ _module_preset=”default” custom_margin=”0px|0px|0px|0px|false|false” custom_padding=”0px|0px|0px|0px|false|false” locked=”off” global_colors_info=”{}”][et_pb_row _builder_version=”4.19.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.19.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_post_title author=”off” categories=”off” comments=”off” featured_image=”off” _builder_version=”4.19.4″ _module_preset=”default” title_text_color=”#555555″ title_font_size=”48px” meta_text_color=”#73B1BD” meta_font_size=”24px” title_font_size_tablet=”42px” title_font_size_phone=”32px” title_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}”][\/et_pb_post_title][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Inhalt” _builder_version=”4.19.4″ _module_preset=”default” custom_margin=”0px|0px|0px|0px|false|false” custom_padding=”0px|0px|0px|0px|false|false” locked=”off” global_colors_info=”{}”][et_pb_row column_structure=”1_2,1_2″ _builder_version=”4.22.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.22.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” custom_padding=”0px|||||” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n

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Authorisation of NON-STERILE implants remains in place, traceability is also given here.<\/strong><\/h3>\n

Non-sterile packaged implants remain approved, however the widespread assumption that exact traceability is only guaranteed through sterile packaged implants. The MDR\u2018s transitory provisions are governed by the amending regulation (EU) 2023\/607. Furthermore, the MDR does not require individual packaging of small surgical products. This means that previously used non-sterile packaged surgical kits and operation sets will remain available for continued use. The Federal Ministry of Health responded, \u201eI can answer your enquir y as to whether Germany is planning to introduce regulations that would mean implantable products (especially small surgical implants such as screws, plates, and nails) must be suppl ied in sterile individual packaging with a clear \u201eNo!\u201c.<\/p>\n

\u201cFederal Ministry of Health<\/a>.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.22.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.koenigsee-implantate.de\/wp-content\/uploads\/2024\/06\/mdr_title-scaled.jpg” alt=”What you need to know” title_text=”mdr_title” _builder_version=”4.25.0″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.24.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.24.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.25.0″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n

The advantages and disadvantages of non-sterile and sterile packaged implants<\/h2>\n

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Non-sterile packaged implants offer numerous advantages. They are more cost-effective to manufacture, store and use. In contrast to sterile-packed implants, which have to undergo a more complex and energy-intensive external sterilization process, non-sterile-packed implants are more flexible to use.<\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.24.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.24.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.koenigsee-implantate.de\/wp-content\/uploads\/2025\/05\/EN_MDR_steril_unsteril_ED02_druck-2.png” alt=”Advantages and Disadvantages” title_text=”EN_MDR_steril_unsteril_ED02_druck-2″ _builder_version=”4.27.4″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.21.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_row column_structure=”1_2,1_2″ _builder_version=”4.25.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.25.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n

Make the right decision<\/strong><\/h3>\n

Sterile-packed implants require more energy, packaging materials, and generate more waste. The increased consumption of resources has both financial and environmental consequences. Non-sterile surgical kits are a cost-effective and environmentally friendly alternative. Consider these benefits to make an informed decision that balances financial and environmental concerns.<\/p>\n

[\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.25.0″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.25.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_row column_structure=”1_2,1_2″ _builder_version=”4.25.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.25.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.koenigsee-implantate.de\/wp-content\/uploads\/2025\/05\/EN_MDR_steril_unsteril_ED02_druck-2_2.png” alt=”Commitment to sustainability” title_text=”EN_MDR_steril_unsteril_ED02_druck-2_2″ _builder_version=”4.27.4″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″][\/et_pb_image][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.25.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.koenigsee-implantate.de\/wp-content\/uploads\/2025\/05\/EN_MDR_steril_unsteril_ED02_druck-1_3.png” alt=”What we stand for” title_text=”EN_MDR_steril_unsteril_ED02_druck-1_3″ _builder_version=”4.27.4″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"

Non-sterile implants remain authorised, contrary to the widespread assumption that exact traceability is only guaranteed via sterile implants. According to Article 18 of the MDR, this assumption is excluded. The MDR Regulation EU 2023\/607 regulates the transitional provisions, the repeal and entry into force as well as the date of application.<\/p>\n","protected":false},"author":1,"featured_media":23069,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[224],"tags":[800,799],"class_list":["post-23110","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-mdr-en","tag-medical-device-regulation-en"],"_links":{"self":[{"href":"https:\/\/www.koenigsee-implantate.de\/en\/wp-json\/wp\/v2\/posts\/23110","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.koenigsee-implantate.de\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.koenigsee-implantate.de\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.koenigsee-implantate.de\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.koenigsee-implantate.de\/en\/wp-json\/wp\/v2\/comments?post=23110"}],"version-history":[{"count":9,"href":"https:\/\/www.koenigsee-implantate.de\/en\/wp-json\/wp\/v2\/posts\/23110\/revisions"}],"predecessor-version":[{"id":30836,"href":"https:\/\/www.koenigsee-implantate.de\/en\/wp-json\/wp\/v2\/posts\/23110\/revisions\/30836"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.koenigsee-implantate.de\/en\/wp-json\/wp\/v2\/media\/23069"}],"wp:attachment":[{"href":"https:\/\/www.koenigsee-implantate.de\/en\/wp-json\/wp\/v2\/media?parent=23110"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.koenigsee-implantate.de\/en\/wp-json\/wp\/v2\/categories?post=23110"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.koenigsee-implantate.de\/en\/wp-json\/wp\/v2\/tags?post=23110"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}