[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-167415-en":3,"doc-seo-167415-105":30,"detail-sidebar-cat-1-en-105":92},{"code":4,"msg":5,"data":6},0,"success",{"doc_id":7,"user_id":8,"nickname":9,"user_avatar":10,"doc_module":11,"category_id":12,"category_name":13,"doc_title":14,"doc_description":15,"doc_content":16,"file_id":17,"file_url":18,"file_type":19,"file_size":20,"view_count":11,"is_deleted":4,"is_public":11,"is_downloadable":11,"audit_status":11,"page_count":21,"language":22,"language_code":23,"site_id":24,"html_lang":23,"table_of_contents":25,"faqs":26,"seo_title":27,"seo_description":15,"update_tm":28,"read_time":29},167415,962084925782,"Chloe Bennett","https://ap-avatar.wpscdn.com/davatar_9964176cb1d06d4a9deccf72a44ae3dc",1,11,"Presentations","Scope of Document - Collaborative Notified Body Approach","Best practice guidance outlines a unified expectations framework for manufacturers submitting technical documentation to notified bodies using a collaborative approach. It aligns submission guidance with EU Medical Devices Regulation MDR 2017/745, focusing on how manufacturers prepare complete, traceable, and cohesively structured files. It addresses common delay drivers, communication steps before application, and requirements for including up-to-date comprehensive reports, complete verification data, and documented compliance against all applicable GSPRs.","Information to be supplied by the manufacturer –\na collaborative notified body approach.\n\u0003Contents\n\u0013 TOC \\o \"1-3\" \\h \\z \\u \u0014\u0013 HYPERLINK \\l \"_Toc115825717\" \u0014Scope of Document\t\u0013 PAGEREF _Toc115825717 \\h \u00143\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc115825718\" \u0014General Considerations\t\u0013 PAGEREF _Toc115825718 \\h \u00143\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc115825719\" \u0014Device Description & Specifications - Including Variants, Accessories, Classification & Materials\t\u0013 PAGEREF _Toc115825719 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc115825720\" \u00141.\tDevice description and specification details should include:\t\u0013 PAGEREF _Toc115825720 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc115825721\" \u00142.\tReference to previous and similar generations of the device\t\u0013 PAGEREF _Toc115825721 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc115825722\" \u0014Information to be supplied by manufacturer (Includes Declaration of Conformity, Labelling, IFU, Implant Card, Surgical Technique brochure etc.)\t\u0013 PAGEREF _Toc115825722 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc115825723\" \u0014Design & Manufacturing Information\t\u0013 PAGEREF _Toc115825723 \\h \u001413\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc115825724\" \u0014Sites and Subcontractors\t\u0013 PAGEREF _Toc115825724 \\h \u001414\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc115825725\" \u0014General Safety & Performance Requirements (GSPRs)\t\u0013 PAGEREF _Toc115825725 \\h \u001415\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc115825726\" \u0014Benefit Risk Analysis and Risk Management\t\u0013 PAGEREF _Toc115825726 \\h \u001416\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc115825727\" \u0014Product Verification and Validation\t\u0013 PAGEREF _Toc115825727 \\h \u001419\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc115825728\" \u0014Biocompatibility\t\u0013 PAGEREF _Toc115825728 \\h \u001419\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc115825729\" \u0014Software & Software Validation (Including Cyber Security)\t\u0013 PAGEREF _Toc115825729 \\h \u001421\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc115825730\" \u0014Electrical Safety and Electromagnetic Compatibility (EMC)\t\u0013 PAGEREF _Toc115825730 \\h \u001425\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc115825731\" \u0014Packaging, Stability and Shelf-Life\t\u0013 PAGEREF _Toc115825731 \\h \u001427\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc115825732\" \u0014Performance and Safety - Design Verification and Validations (including devices with a measuring or diagnostic function, MR Compatibility)\t\u0013 PAGEREF _Toc115825732 \\h \u001428\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc115825733\" \u0014Usability\t\u0013 PAGEREF _Toc115825733 \\h \u001428\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc115825734\" \u0014Devices Incorporating Medicinal and Biological Materials\t\u0013 PAGEREF _Toc115825734 \\h \u001429\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc115825735\" \u0014Drug/Device Combination Products\t\u0013 PAGEREF _Toc115825735 \\h \u001429\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc115825736\" \u0014Human Origin Matter\t\u0013 PAGEREF _Toc115825736 \\h \u001431\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc115825737\" \u0014Animal Origin Matter\t\u0013 PAGEREF _Toc115825737 \\h \u001432\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc115825738\" \u0014Biological Origin Matter\t\u0013 PAGEREF _Toc115825738 \\h \u001434\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc115825739\" \u0014Substances absorbed or locally dispersed\t\u0013 PAGEREF _Toc115825739 \\h \u001434\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc115825740\" \u0014Hazardous substances, CMR, endocrine disrupting substances\t\u0013 PAGEREF _Toc115825740 \\h \u001436\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc115825741\" \u0014Sterilisation & Reusable Surgical Instruments\t\u0013 PAGEREF _Toc115825741 \\h \u001437\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc115825742\" \u0014Clinical Evaluation (Includes SSCP labelling)\t\u0013 PAGEREF _Toc115825742 \\h \u001439\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc115825743\" \u0014Post Market Surveillance\t\u0013 PAGEREF _Toc115825743 \\h \u001444\u0015\u0015\n\u0015\n\u000f\n\u0004\nScope of Document\nThis best practice guidance document has been developed by members of Team NB who have reviewed the best practice guidance documents submitted by individual Team NB notified body members, with the purpose to develop a unified approach on the expectations of technical documentation submissions from manufacturers.\nThis technical documentation submission guidance is aligned to the requirements of Medical Devices Regulation [MDR] (EU) 2017/745, described in detail in Annexes II and III of Regulation (EU) 2017/745.\nDisclaimer:\nThe content of the best practice guidance is based on the interpretation of the Medical Device Regulation EU 2017/745 by Team NB and affiliated notified bodies. During a technical documentation assessment, it may be required that additional documentation/information may be needed to b","cbCaiunh5wId7wSt","https://ap.wps.com/l/cbCaiunh5wId7wSt","docx",105676,45,"English","en",105,"# Scope of Document\n## General Considerations\n## Device Description & Specifications\n## Information to be supplied by manufacturer\n## Design & Manufacturing Information\n## General Safety & Performance Requirements (GSPRs)\n## Benefit Risk Analysis and Risk Management\n## Product Verification and Validation\n## Biocompatibility\n## Software & Software Validation (Including Cyber Security)\n## Electrical Safety and Electromagnetic Compatibility (EMC)","[{\"question\":\"What is the purpose of this best practice guidance document?\",\"answer\":\"It defines a unified approach to expectations for technical documentation submissions reviewed by members of Team NB and affiliated notified bodies.\"},{\"question\":\"Which regulation does the guidance align with?\",\"answer\":\"The guidance aligns with the Medical Devices Regulation (EU) 2017/745, specifically referenced through requirements in Annexes II and III.\"},{\"question\":\"Why do technical documentation reviews by notified bodies often experience delays?\",\"answer\":\"Common reasons include incomplete submissions and a lack of cohesive structure that makes information difficult to locate.\"}]","Scope of Document - 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