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As of 10 January 2025<\/strong>, a new obligation introduced by Regulation (EU) 2024\/1860<\/a>, <\/strong>under the MDR\/IVDR requires manufacturers to notify relevant parties in advance when an interruption or discontinuation of supply is reasonably foreseeable and could result in serious harm or a risk of serious harm to patients or public health in one or more Member States \u2013 this is the very basic summary of Article 10a<\/strong>!<\/p>\n This applies to both legacy and MDR-compliant devices, with custom-made devices being excluded.<\/p>\n <\/p>\n So, what is required by Article 10a?<\/strong><\/p>\n If a manufacturer anticipates a disruption or discontinuation in a device supply that could risk patient safety or public health, they must:<\/p>\n This notification must be made at least six months in advance (exceptions apply) and must include the reasons for the anticipated interruption or discontinuation.<\/strong><\/p>\n After receiving this information, the competent authority must promptly inform the competent authorities in other EU countries, and the EU Commission.<\/strong><\/p>\n Economic operators are also required to pass on the notification to their downstream partners, so its important for distributors to also be aware of Article 10a!<\/p>\n To assist with implementation, the European Commission has released:<\/p>\n But there are still some practical challenges remain, especially in identifying what constitutes a “reasonably foreseeable” disruption.<\/p>\n <\/p>\n What manufacturers should do now<\/strong><\/p>\n If you haven\u2019t already, now is the time to:<\/p>\n Article 10a introduces yet another regulatory burden for manufacturers\u2014but with a fit-to-need compliance strategy, it becomes manageable. If your team needs support to meet these new requirements, All4Compliance is here to help!<\/p>\n <\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ custom_padding_last_edited=”on|tablet” admin_label=”Drive Footer – Grace” _builder_version=”4.19.5″ _module_preset=”default” background_enable_color=”off” background_image=”https:\/\/all4compliance.pt\/wp-content\/uploads\/2023\/02\/All4coplince-1-50.png” background_blend=”multiply” custom_padding=”45px||14px||false|false” custom_padding_tablet=”30px||0px||false|false” custom_padding_phone=”||||false|false” global_module=”376224″ saved_tabs=”all” locked=”off” collapsed=”off” global_colors_info=”{}”][et_pb_row column_structure=”1_3,1_3,1_3″ admin_label=”Drive Footer – Grace – Row” _builder_version=”4.19.5″ _module_preset=”default” width=”90%” max_width=”1170px” custom_padding=”||40px||false|false” global_colors_info=”{}” body_link_text_color__hover=”#fafafa” body_link_text_color__hover_enabled=”on|hover”][et_pb_column type=”1_3″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/all4compliance.pt\/wp-content\/uploads\/2023\/02\/logo-footer-final.png” title_text=”logo-footer-final” _builder_version=”4.19.5″ _module_preset=”default” width=”95%” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Address” content_max_width=”100%” admin_label=”Drive Footer – Grace – Address” _builder_version=”4.23.1″ _module_preset=”default” header_font=”Poppins||||||||” header_text_color=”#ffffff” header_line_height=”120%” body_font=”Barlow||||||||” body_text_color=”#FFFFFF” body_font_size=”16px” body_line_height=”165%” body_link_font=”||||||||” body_link_text_color=”#999999″ body_link_font_size=”16px” custom_margin=”||14px|||” global_colors_info=”{}” body_link_text_color__hover_enabled=”on|hover” body_link_text_color__hover=”#d7b994″]<\/p>\n Biocant Park | N\u00facleo 04 Lote 2 | Quality Policy<\/a><\/p>\n [\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Social Media” content_max_width=”100%” admin_label=”Drive Footer – Grace – Address” _builder_version=”4.20.4″ _module_preset=”default” header_font=”Poppins||||||||” header_text_color=”#ffffff” header_line_height=”120%” body_font=”Barlow||||||||” body_text_color=”#999999″ body_font_size=”16px” body_line_height=”165%” body_link_font=”||||||||” body_link_text_color=”#999999″ body_link_font_size=”16px” custom_margin=”||14px|||” global_colors_info=”{}” body_link_text_color__hover_enabled=”on|hover” body_link_text_color__hover=”#d7b994″][\/et_pb_blurb][et_pb_social_media_follow icon_color=”#ffffff” use_icon_font_size=”on” icon_font_size=”23px” icon_font_size_tablet=”18px” icon_font_size_phone=”18px” icon_font_size_last_edited=”on|tablet” admin_label=”Drive Footer – Grace – Social Media Follow” _builder_version=”4.19.5″ _module_preset=”default” text_orientation=”left” custom_margin=”||6px|||” text_orientation_tablet=”left” text_orientation_phone=”left” text_orientation_last_edited=”on|tablet” global_colors_info=”{}” icon_color__hover_enabled=”on|hover” icon_color__hover=”#d7b994″][et_pb_social_media_follow_network social_network=”linkedin” _builder_version=”4.19.2″ _module_preset=”default” background_color=”#007bb6″ background_enable_color=”off” global_colors_info=”{}” follow_button=”off” url_new_window=”on”]linkedin[\/et_pb_social_media_follow_network][et_pb_social_media_follow_network social_network=”rss” _builder_version=”4.19.4″ _module_preset=”default” background_enable_color=”off” global_colors_info=”{}” follow_button=”off” url_new_window=”on”]rss[\/et_pb_social_media_follow_network][\/et_pb_social_media_follow][et_pb_button button_url=”\/en\/contacts\/” button_text=”Contact us” button_alignment=”left” _builder_version=”4.20.4″ _module_preset=”default” custom_button=”on” button_text_size=”17px” button_text_color=”#FFFFFF” button_bg_color=”#56a09a” button_border_color=”#56a09a” button_border_radius=”50px” global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][\/et_pb_row][et_pb_row admin_label=”Drive Footer – Grace – Row” _builder_version=”4.16″ _module_preset=”default” width=”90%” max_width=”1170px” border_width_top=”1px” border_color_top=”#FFFFFF” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_text admin_label=”Drive Footer – Grace – Copyright \u00a9” _builder_version=”4.20.4″ _module_preset=”default” text_font=”Barlow||||||||” text_text_color=”#FFFFFF” text_font_size=”16px” text_orientation=”center” custom_css_main_element=”font-weight: 400;” global_colors_info=”{}”]\u00a9 All4Compliance, All rights reserved. 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Portugal<\/p>\n