[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-354854-105":53,"doc-detail-354854-en":126},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":119,"head_meta":121,"extra_data":123,"updated_unix":125},105,"en","the-clinical-development-plan-clinical-development-plan-cdp-strategies-for-planning-medical-device-clinical-evaluation","The clinical development plan - Clinical Development Plan (CDP) - Strategies for planning medical device clinical evaluation","","The article explains the role of the Clinical Development Plan (CDP) within the EU Medical Device Regulation (MDR), noting that MDR references CDP in Annex XIV and requiring manufacturers to plan, continuously conduct, and document clinical evaluation. It clarifies CDP as a subset of the Clinical Evaluation Plan (CEP) focused on clinical investigations already performed, ongoing, or planned (including pilot, pivotal, and PMCF). It provides guidance for presenting CDP inside CEP and outlines questions and strategies to align study design with regulatory and business objectives.",{"@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":41,"@type":70,"position":76},"https://docshare.wps.com/template/letters/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/the-clinical-development-plan-clinical-development-plan-cdp-strategies-for-planning-medical-device-clinical-evaluation/354854/",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/the-clinical-development-plan-clinical-development-plan-cdp-strategies-for-planning-medical-device-clinical-evaluation/354854.png","ImageObject",442,249,{"name":88,"@type":89},"Kyle","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-17","2026-09-22",true,{"@type":98,"interactionType":99,"userInteractionCount":73},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What is the Clinical Development Plan (CDP) under MDR Annex XIV?","Question",{"text":108,"@type":109},"The CDP is presented as a clinical development plan that shows progression from exploratory investigations (e.g., first-in-man, feasibility and pilot studies) to confirmatory investigations (e.g., pivotal studies) and includes milestones and acceptance criteria tied to PMCF.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"How does the CDP relate to the Clinical Evaluation Plan (CEP)?",{"text":113,"@type":109},"The CEP describes the overall clinical strategy to justify safety and performance. The CDP is a subset of the CEP focused specifically on the clinical investigations for the device that have been conducted, are being conducted, or are planned, including possible PMCF studies.",{"name":115,"@type":106,"acceptedAnswer":116},"What options can manufacturers use when formulating the CDP in the CEP?",{"text":117,"@type":109},"The CDP may be written in paragraphs or presented as a table. Formulation should address what kind of clinical investigation is needed (pilot, pivotal, or PMCF), whether non-randomized but statistically sound designs are feasible, and how inclusion/exclusion criteria and endpoints/acceptance criteria are presented.","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},354854,1792215408,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":40,"category_name":41,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":73,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":73,"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":139,"read_time":9},3985741905716,"https://ap-avatar.wpscdn.com/davatar_994ba38a5ba835b3df7d355c54d3ed8d","The clinical development plan  \nNamrata Upadhyay  \nTeam Manager Medical Writing and Safety Reporting  \nMD-Clinicals, Switzerland  \nCorrespondence to:  \n[dr.namratau87@gmail.com](dr.namratau87@gmail.com)  \nAbstract  \nThe Medical Device Regulation (MDR) mentions the term “Clinical Development Plan”(CDP) only twice, both of which are in AnnexXIV. This article aims to delve deeper than theMDR into what the CDP entails and to propose the best strategies for a manufacturer to plan their medical device’s clinical evaluation.  \nAlthough there is no official definition of the CDP, one may simply refer to it as an overview of all the clinical investigations that have either been performed, are ongoing, or are planned in the near future, presented in the Clinical Evaluation Plan (CEP) of the medical device under evaluation.  \nThis article is intended to assist medical device manufacturers and medical writers to leverage the CDP as a tool to showcase their clinical evaluation strategy and plan.  \nThe Clinical Development Plan (CDP) as per the Medical Device Regulation (MDR)  \nnT   \nhe MDR provides a complete list of criteria to continuously conduct and  \ndocument a clinical evaluation in Annex XIV, 1  \nF  \nwhere we get introduced to the term CDP for the first time as follows:  \n“To plan, continuously conduct and document a clinical evaluation, manufacturers shall establish and update a clinical evaluation plan, which should include (amongst other criteria):  \nl a clinical development plan indicating progression from exploratory investigations, such as first-in-man studies, feasibility and pilot studies, to confirmatory investigations, such as pivotal clinical investigations, and a PMCF [Post-Market Clinical Follow-up] as referred to in Part B of this Annex with an indication of milestones and a description of potential acceptance criteria.  \nl generate, through properly designed clinical investigations in accordance with the clinical development plan, any new or additional clinical data necessary to address outstanding issues.”  \nThe relationship between CDP and CEP  \nThe CEP outlines the clinical strategy that the manufacturer shall follow to justify the safety and performance of their device in accordance with the General Safety and Performance Requirements (GSPR) of theMDR. The CDPisa subset of the CEP focusing specifically on the clinical investigations for the given device that:  \na. Have already been conducted, preferably with a full clinical investigation report available  \nb. Are being conducted with a full clinical investigation protocol available, or  \nc. Are planned in the future – these could include pilot, pivotal, or PMCF studies. Preferably, the synopsis of this study should be included in the CDP in this case.  \nHow to present the CDP in the CEP  \nAnnex I of ISO 14155:2020 explains, in detail, the differences between pilot, pivotal, and PMCF clinical investigations and acts as an excellent reference for the CDP. (See the September 2021 issue of MEW for a flowchart of ISO 14155:2020, p. 96) .  \nAsforthe presentation itself, the CDP maybe written in paragraphs or presented as a table. Questions to ask during the formulation of a CDP may include:  \n1. Based on the literature review results and the CE mark status of the device (i.e. pre-CE  \nmark or already CE marked), what kind of clinical investigation (CI) are we looking at for the evaluated device? Is it a pilot/pivotal or post market clinical follow-up (PMCF) CI?  \n2. Has the possibility to do a statistically sound, non-randomized CI, instead of a randomisedone, been explored? (Randomized studies are not always essential for regulatory approval of medical devices depending on the specific case, type and class of device. It should however be ISO 14155:2020 compliant irrespective of study design).  \n3. Have we outlined the inclusion/exclusion criteria in the CDP ofour CIs?  \n4. What were the endpoints/acceptance criteria of our previous clinical investigations? Has it been ","cbCaib6XJn5j7nJX","https://ap.wps.com/l/cbCaib6XJn5j7nJX","pdf",262788,"English","# Abstract\n# The Clinical Development Plan (CDP) as per the Medical Device Regulation (MDR)\n# The relationship between CDP and CEP\n# How to present the CDP in the CEP\n# MDCG document references for the CDP writing","[{\"question\":\"What is the Clinical Development Plan (CDP) under MDR Annex XIV?\",\"answer\":\"The CDP is presented as a clinical development plan that shows progression from exploratory investigations (e.g., first-in-man, feasibility and pilot studies) to confirmatory investigations (e.g., pivotal studies) and includes milestones and acceptance criteria tied to PMCF.\"},{\"question\":\"How does the CDP relate to the Clinical Evaluation Plan (CEP)?\",\"answer\":\"The CEP describes the overall clinical strategy to justify safety and performance. The CDP is a subset of the CEP focused specifically on the clinical investigations for the device that have been conducted, are being conducted, or are planned, including possible PMCF studies.\"},{\"question\":\"What options can manufacturers use when formulating the CDP in the CEP?\",\"answer\":\"The CDP may be written in paragraphs or presented as a table. Formulation should address what kind of clinical investigation is needed (pilot, pivotal, or PMCF), whether non-randomized but statistically sound designs are feasible, and how inclusion/exclusion criteria and endpoints/acceptance criteria are presented.\"}]","The clinical development plan - Clinical Development Plan (CDP) - Strategies for planning medical device clinical evaluation | PDF",1790114420]