[et_pb_section fb_built=”1″ admin_label=”Section – European Union” _builder_version=”4.27.4″ _module_preset=”default” background_color=”#FFFCFC” collapsed=”on” global_colors_info=”{}”][et_pb_row admin_label=”European Union” _builder_version=”4.27.4″ _module_preset=”default” custom_padding=”||||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.22.1″ _module_preset=”default” global_colors_info=”{}”][et_pb_heading title=”For diagnostic laboratories in the European Union” _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_heading][et_pb_heading title=”The WID\u00ae-easy test as IVDR Article 5 (5) test” _builder_version=”4.27.4″ _module_preset=”default” title_level=”h2″ global_colors_info=”{}”][\/et_pb_heading][et_pb_heading title=”The regulatory basis” _builder_version=”4.27.4″ _module_preset=”default” title_level=”h3″ global_colors_info=”{}”][\/et_pb_heading][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” custom_margin=”||||false|false” global_colors_info=”{}”]<\/p>\n
Healthcare facilities, such as diagnostic laboratories, have the possibility to manufacture and use the WID\u00ae-easy tests in accordance with Regulation (EU) 2017\/746 on in vitro diagnostic medical devices<\/span> (IVDR) Chapter II, Article 5 (5)<\/a>or corresponding national regulations.<\/p>\n The necessary scientific and technical information can be found in the published literature, in particular Evans et al, The Lancet Oncology, 2023<\/a>.<\/p>\n [\/et_pb_text][et_pb_heading title=”Clarifications and comments” _builder_version=”4.27.4″ _module_preset=”default” title_level=”h3″ global_colors_info=”{}”][\/et_pb_heading][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n In January 2023, the Medical Device Coordination Group (MDCG)<\/a> published the“Guidance on the health institution exemption under Article 5 (5) of Regulation (EU) 2017\/745 and Regulation (EU) 2017\/746<\/a>“, which clarifies and comments on key aspects of the regulatory basis.<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row admin_label=”PCR kit” _builder_version=”4.27.4″ _module_preset=”default” custom_margin=”||||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.22.1″ _module_preset=”default” global_colors_info=”{}”][et_pb_heading title=”The WID\u00ae-easy PCR kit” _builder_version=”4.27.4″ _module_preset=”default” title_level=”h2″ global_colors_info=”{}”][\/et_pb_heading][et_pb_heading title=”Application” _builder_version=”4.27.4″ _module_preset=”default” title_level=”h3″ global_colors_info=”{}”][\/et_pb_heading][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” custom_margin=”||||false|false” global_colors_info=”{}”]<\/p>\n Diagnostic laboratories can obtain all necessary reagents for the production and use of the test from relevant suppliers.<\/p>\n To simplify logistics, healthcare facilities can obtain a set of reagents required to carry out the PCR reaction from Sola Diagnostics GmbH as an RUO PCR kit (“WID\u00ae-easy PCR Kit”).<\/p>\n The legal manufacturer of the RUO WID\u00ae-easy PCR Kit is Sola Diagnostics GmbH. The PCR kit was verified and manufactured in collaboration with BIOTYPE GmbH<\/a> in Dresden (Germany). BIOTYPE has been a renowned German solution provider for precision molecular diagnostics, contract development and production for 25 years. BIOTYPE is certified according to the standards DIN EN ISO 13485 and DIN EN ISO 9001 in the area of sales, development, production and services of molecular biological tests for in-vitro diagnostics (ISO 13485:2016) and for research and diagnostics (ISO 9001:2015).<\/p>\n Sola Diagnostics GmbH provides the WID\u00ae-easy PCR Kit to health institutions at a cost price with no profit margin.<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_2,1_2″ admin_label=”Manual” _builder_version=”4.27.4″ _module_preset=”default” custom_margin=”|auto||auto|false|false” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.22.1″ _module_preset=”default” global_colors_info=”{}”][et_pb_heading title=”IFU – Instructions for Use” admin_label=”Heading” _builder_version=”4.27.4″ _module_preset=”default” title_level=”h3″ global_colors_info=”{}”][\/et_pb_heading][et_pb_text _builder_version=”4.27.6″ _module_preset=”default” link_option_url=”https:\/\/sola-diagnostics.com\/wp-content\/uploads\/2024\/08\/240820_WIDHB01v2en_Handbook-WID-easy-PCR-Kit-RUO-published.pdf” link_option_url_new_window=”on” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n The WID\u00ae-easy PCR Kit IFU – Instructions for Use – can be downloaded from the following link.<\/p>\n WID\u00ae-easy PCR Kit RUO – Instructions for Use (EN)<\/a><\/p>\n [\/et_pb_text][et_pb_heading title=”Safety data sheet” admin_label=”Heading” _builder_version=”4.22.1″ _module_preset=”default” title_level=”h3″ global_colors_info=”{}”][\/et_pb_heading][et_pb_text _builder_version=”4.27.6″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n The WID\u00ae-easy PCR Kit Safety Data Sheets can be downloaded from the following links.<\/p>\n WID\u00ae-easy PCR Kit RUO – Safety Data Sheet (EN)<\/a><\/p>\n WID\u00ae-easy PCR Kit – Non-Hazardous Product Statement (EN)<\/a><\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.22.1″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/sola-diagnostics.com\/wp-content\/uploads\/2023\/10\/IMG_3703_2-removebg-small.png” title_text=”IMG_3703_2-removebg small” url=”https:\/\/sola-diagnostics.com\/wp-content\/uploads\/2024\/08\/240820_WIDHB01v2en_Handbook-WID-easy-PCR-Kit-RUO-published.pdf” url_new_window=”on” align=”center” _builder_version=”4.27.4″ _module_preset=”default” width=”100%” max_width=”100%” max_height=”400px” custom_margin=”0px||||false|false” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row admin_label=”Quality assurance” _builder_version=”4.27.4″ _module_preset=”default” custom_margin=”0px||||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.22.1″ _module_preset=”default” global_colors_info=”{}”][et_pb_heading title=”Quality assurance” admin_label=”Heading” _builder_version=”4.27.4″ _module_preset=”default” title_level=”h3″ global_colors_info=”{}”][\/et_pb_heading][et_pb_heading title=”Certificates of analysis” _builder_version=”4.27.4″ _module_preset=”default” title_level=”h4″ global_colors_info=”{}”][\/et_pb_heading][et_pb_toggle title=”CoA – Batch Code: SOLA-0002″ _builder_version=”4.27.6″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n Download the Certificate of Analysis SOLA-0002<\/a><\/p>\n [\/et_pb_toggle][et_pb_toggle title=”CoA – Batch Code: SOLA-0003″ _builder_version=”4.27.6″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n Download the Certificate of Analysis SOLA-0003<\/a><\/p>\n [\/et_pb_toggle][et_pb_toggle title=”CoA – Batch Code: SOLA-0004″ _builder_version=”4.27.6″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n Download the Certificate of Analysis SOLA-0004<\/a><\/p>\n [\/et_pb_toggle][et_pb_toggle title=”CoA – Batch Code: SOLA-0006″ _builder_version=”4.27.6″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n Download the Certificate of Analysis SOLA-0006<\/a><\/p>\n [\/et_pb_toggle][et_pb_toggle title=”CoA – Batch Code: SOLA-0007″ _builder_version=”4.27.6″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n Download the Certificate of Analysis SOLA-0007<\/a><\/p>\n [\/et_pb_toggle][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Divider” _builder_version=”4.27.4″ _module_preset=”default” background_color=”#FFFCFC” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” saved_tabs=”all” collapsed=”off” global_colors_info=”{}”][et_pb_row _builder_version=”4.27.4″ _module_preset=”default” custom_margin=”0px||0px||false|false” custom_padding=”0px||0px||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_divider color=”#7F5E75″ divider_position=”center” divider_weight=”2px” _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_divider][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ admin_label=”Section – Gro\u00dfbritannien” _builder_version=”4.27.4″ _module_preset=”default” background_color=”#FFFCFC” collapsed=”on” global_colors_info=”{}”][et_pb_row _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.22.1″ _module_preset=”default” global_colors_info=”{}”][et_pb_heading title=”For diagnostic laboratories in Great Britain” admin_label=”F\u00fcr Diagnostische Labore in Gro\u00dfbritannien” _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_heading][et_pb_heading title=”The WID\u00ae-easy test as an in vitro diagnostic (IVD) with UKCA labeling” _builder_version=”4.27.4″ _module_preset=”default” title_level=”h2″ global_colors_info=”{}”][\/et_pb_heading][et_pb_heading title=”The regulatory basis” _builder_version=”4.27.4″ _module_preset=”default” title_level=”h3″ global_colors_info=”{}”][\/et_pb_heading][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n The WID\u00ae-easy PCR Kit as an in vitro diagnostic (IVD) fulfills the requirements of the UK Medical Device Regulation.<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_2,1_2″ admin_label=”Manual” _builder_version=”4.27.4″ _module_preset=”default” custom_margin=”||||false|false” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.22.1″ _module_preset=”default” global_colors_info=”{}”][et_pb_heading title=”IFU – Instructions for Use” admin_label=”Heading” _builder_version=”4.27.4″ _module_preset=”default” title_level=”h3″ global_colors_info=”{}”][\/et_pb_heading][et_pb_text _builder_version=”4.27.6″ _module_preset=”default” link_option_url=”https:\/\/sola-diagnostics.com\/wp-content\/uploads\/2024\/08\/240820_WIDHB01v2en_Handbook-WID-easy-PCR-Kit-RUO-published.pdf” link_option_url_new_window=”on” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n The WID\u00ae-easy PCR Kit IFU – Instructions for Use – for the UK market in accordance with the requirements of the UK Medical Devices Regulations can be downloaded from the following link.<\/p>\n WID\u00ae-easy PCR Kit UKCA marked – Instructions for Use (EN)<\/a><\/p>\n [\/et_pb_text][et_pb_heading title=”Safety data sheet” admin_label=”Heading” _builder_version=”4.27.4″ _module_preset=”default” title_level=”h3″ global_colors_info=”{}”][\/et_pb_heading][et_pb_text _builder_version=”4.27.6″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n The WID\u00ae-easy PCR Kit Safety Data Sheets for the UK market in accordance with the requirements of the UK Medical Devices Regulation can be downloaded from the following links.<\/p>\n WID\u00ae-easy PCR Kit UKCA marked – Safety Data Sheet (EN)<\/a><\/p>\n WID\u00ae-easy PCR Kit – Non-Hazardous Product Statement (EN)<\/a><\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.22.1″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/sola-diagnostics.com\/wp-content\/uploads\/2024\/12\/UKCA_IVD.png” title_text=”UKCA_IVD” align=”center” _builder_version=”4.27.4″ _module_preset=”default” max_height=”366px” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row admin_label=”Quality assurance” _builder_version=”4.27.4″ _module_preset=”default” custom_margin=”||||false|false” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.22.1″ _module_preset=”default” global_colors_info=”{}”][et_pb_heading title=”Quality assurance” admin_label=”Heading” _builder_version=”4.27.4″ _module_preset=”default” title_level=”h3″ global_colors_info=”{}”][\/et_pb_heading][et_pb_heading title=”Certificates of analysis” _builder_version=”4.27.4″ _module_preset=”default” title_level=”h4″ global_colors_info=”{}”][\/et_pb_heading][et_pb_toggle title=”CoA – Batch Code: SOLA-0005″ _builder_version=”4.27.6″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n Download the Certificate of Analysis SOLA-0005<\/a><\/p>\n [\/et_pb_toggle][et_pb_toggle title=”CoA – Batch Code: SOLA-0006″ _builder_version=”4.27.6″ _module_preset=”default” hover_enabled=”0″ global_colors_info=”{}” sticky_enabled=”0″]<\/p>\n