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It covers extended transitional periods when IVDD conformity assessment procedures did not require a notified body, where a notified body becomes required under IVDR, and the validity of Directive 98/79/EC certificates. The declaration confirms continued placing on the market and putting into service through selectable statements on applications, agreements, expiry conditions, derogations or requirements, and Quality Management System (QMS) status.",{"@graph":63,"@context":118},[64,80,101],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":36,"@type":70,"position":76},"https://docshare.wps.com/template/forms/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/manufacturers-declaration-transitional-provisions-ivdr-eu-20241860/164696/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/manufacturers-declaration-transitional-provisions-ivdr-eu-20241860/164696.png","ImageObject",442,249,{"name":88,"@type":89},"Tawan","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-23","2026-08-31",true,{"@type":98,"interactionType":99,"userInteractionCount":47},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What legal basis does this Manufacturer’s Declaration reference for transitional provisions?","Question",{"text":108,"@type":109},"It references Regulation (EU) 2024/1860 amending Regulation (EU) 2017/746 (IVDR), including transitional provisions connected to earlier IVDD requirements and certificate validity under Directive 98/79/EC (IVDD).","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"Which situations can the declaration cover regarding notified body involvement and conformity assessment?",{"text":113,"@type":109},"It covers devices where IVDD did not require a notified body but IVDR requires notified body involvement, and it also addresses extension conditions related to certificates issued under IVDD and compliance for continued market placement and service.",{"name":115,"@type":106,"acceptedAnswer":116},"What does the declaration require the manufacturer to confirm about the Quality Management System (QMS)?",{"text":117,"@type":109},"It provides selectable statements confirming whether the QMS is in place or will be implemented by specified deadlines, and whether the notified body has issued a certificate for an IVDR-compliant QMS.","https://schema.org",{"og:url":78,"og:type":120,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":122,"canonical":78},"index,follow",{"doc_id":124,"site_id":56},164696,1788159206,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":35,"category_name":36,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":47,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":47,"language":135,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":136,"faqs":137,"seo_title":138,"seo_description":61,"update_tm":125,"read_time":73},2336475104042,"https://ap-avatar.wpscdn.com/avatar/22000c4c32af1715be0?x-image-process=image/resize,m_fixed,w_180,h_180&k=1786537525561427321","Manufacturer’s Declaration\nin relation to Regulation (EU) 2024/1860 ​amending Regulation (EU) 2017/746 (IVDR) as regards the transitional provisions for certain in vitro diagnostic medical devices, in particular with respect to\nthe extended transitional periods for devices for which the conformity assessment procedure pursuant to Directive 98/79/EC (IVDD) did not require the involvement of a notified body, for which the declaration of conformity was drawn up prior to 26 May 2022 and for which the conformity assessment procedure pursuant to Regulation (EU) 2017/746 (IVDR) requires the involvement of a notified body and/or\nthe validity of certificates issued under Directive 98/79/EC (IVDD) (Directive Certificate) and/or\nthe compliance of the devices and us, as their manufacturer, with the conditions for the continued placing on the market and putting into service\nWe, as the manufacturer declare under our sole responsibility:\nfor the device(s) listed in the attached schedule the conditions for the legal extension of transitional periods as required in Article 110.3b of the IVDR are met and/or\nfor the Directive Certificate(s) listed in the attached schedule the conditions for the legal extension of validity as required in Article 110.2 of the IVDR are met and/or\nthe device(s) listed in the attached schedule and we as their manufacturer are in compliance with the conditions listed in Article 110.3c of the IVDR for continued placing on the market and putting into service,\nnamely by fulfilling the following conditions:\nDevices which were self-declared under the IVDD and require notified body involvement under the IVDR\nIn case of devices for which the conformity assessment procedure pursuant to IVDD did not require the involvement of a notified body, for which the declaration of conformity was drawn up prior to 26 May 2022 and for which the conformity assessment procedure pursuant to IVDR requires the involvement of a notified body:\nChoose one applicable statement:\n\u0003☐\u0004 Formal application(s) to the notified body in accordance with Section 4.3, first subparagraph of Annex VII IVDR for conformity assessment has/have been lodged or will be lodged by us to a notified body for the device(s) listed in the attached schedule or its/their substitutes no later than:\n\u0003☐\u0004 26 May 2025 for class D devices\n\u0003☐\u0004 26 May 2026 for class C devices\n\u0003☐\u0004 27 May 2027 for class B and class A (sterile) devices\n\u0003☐\u0004 Signed written agreement(s) is/will be in place in accordance with Section 4.3, second subparagraph of Annex VII IVDR for the device(s) listed in the attached schedule or its/their substitutes no later than:\n\u0003☐\u0004 26 September 2025 for class D devices\n\u0003☐\u0004 26 September 2026 for class C devices\n\u0003☐\u0004 27 September 2027 for class B and class A (sterile) devices\n\u0003☐\u0004 We do not intend to lodge an application for conformity for the device as indicated on the attached schedule.\nDirective Certificate(s) as listed above or in the attached schedule\nDirective Certificate(s) covering the device(s) listed in the attached schedule was/were issued after 25 May 2017, was/were valid on 26 May 2022 and has/have not been withdrawn afterwards.\nChoose applicable statements:\n\u0003☐\u0004 Original expiry date before 9 July 2024:\n\u0003☐\u0004 Before the original date of expiry as indicated on the Directive Certificate(s), we and the notified body have signed written agreement(s) in accordance with Section 4.3, second subparagraph of Annex VII IVDR for the conformity assessment(s) in respect of the device(s) covered by the expired certificate(s) or in respect of its/their substitute(s), or\n\u0003☐\u0004 Competent Authority has granted a derogation from the applicable conformity assess\u001fment pro\u001fcedure in accordance with Article 54(1) IVDR (may be provided upon request), or\n\u0003☐\u0004 Competent Authority has required us as the manufacturer, in accord\u001fance with Article 92(1) IVDR, to carry out the applicable conformity assessment pro\u001fcedure (may be provided upon request)\nChoose one of the following statements only if a ","cbCaitz9ltrfv7yh","https://ap.wps.com/l/cbCaitz9ltrfv7yh","docx",48606,"English","# Manufacturer’s Declaration\n## Transitional provisions under (EU) 2024/1860\n## Conditions for legal extension under Article 110\n## Notified body involvement and applicable statements\n## Directive certificate validity and expiry conditions\n## Derogations or conformity assessment requirements\n## Quality Management System (QMS) statements\n## Continued placing on the market and putting into service","[{\"question\":\"What legal basis does this Manufacturer’s Declaration reference for transitional provisions?\",\"answer\":\"It references Regulation (EU) 2024/1860 amending Regulation (EU) 2017/746 (IVDR), including transitional provisions connected to earlier IVDD requirements and certificate validity under Directive 98/79/EC (IVDD).\"},{\"question\":\"Which situations can the declaration cover regarding notified body involvement and conformity assessment?\",\"answer\":\"It covers devices where IVDD did not require a notified body but IVDR requires notified body involvement, and it also addresses extension conditions related to certificates issued under IVDD and compliance for continued market placement and service.\"},{\"question\":\"What does the declaration require the manufacturer to confirm about the Quality Management System (QMS)?\",\"answer\":\"It provides selectable statements confirming whether the QMS is in place or will be implemented by specified deadlines, and whether the notified body has issued a certificate for an IVDR-compliant QMS.\"}]","Manufacturer’s Declaration - Transitional Provisions IVDR (EU) 2024/1860 | DOCX"]