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It covers submission scope, consistency requirements across technical-file documents, and how update frequencies should be defined and justified based on device classification, risk profile, and research activity. It also outlines expected timing for final versions, version control and sign-off, and the regulatory pathway options for collecting supporting clinical data. It emphasizes that a well-defined Clinical Evaluation Plan supports a compliant Clinical Evaluation Report.",{"@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/best-practice-guidance-for-the-submission-of-clinical-evaluation-documentation-for-conformity-assessment-by-the-notified-body/354851/",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/best-practice-guidance-for-the-submission-of-clinical-evaluation-documentation-for-conformity-assessment-by-the-notified-body/354851.png","ImageObject",442,249,{"name":88,"@type":89},"\tCallum ","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-08","2026-09-22",true,{"@type":98,"interactionType":99,"userInteractionCount":9},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What is the document’s scope regarding clinical evaluation submissions to a Notified Body?","Question",{"text":108,"@type":109},"It covers legislative aspects of clinical evaluation under Regulation (EU) 2017/745 (MDR) from a Notified Body perspective, guiding manufacturers on best practices for developing clinical evaluation documentation.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"How should manufacturers handle update frequency and document alignment before submission?",{"text":113,"@type":109},"Manufacturers should ensure consistency across all documents submitted to the Notified Body and define and justify the update frequency for the clinical evaluation documentation, including the clinical evaluation report.",{"name":115,"@type":106,"acceptedAnswer":116},"Why is a Clinical Evaluation Plan (CEP) critical before creating the Clinical Evaluation Report (CER)?",{"text":117,"@type":109},"A good clinical evaluation starts with a well-defined CEP; without it, the CER may fail to meet MDR requirements and can lead to challenges or refusal during conformity assessment.","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},354851,1791500122,{"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":9,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":135,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":140,"read_time":15},137451211410,"https://ap-avatar.wpscdn.com/avatar/2000bb0a9246f588df?x-image-process=image/resize,m_fixed,w_180,h_180&k=1786362646172706240","Best Practice Guidance  \nFor the Submission of Clinical Evaluation Documentation for Conformity Assessment by the Notified Body  \nContents  \n1  \n3  \nScope  \nGeneral considerations for submission  \nThe Clinical Evaluation Documentation  \n31 The clinical oversight process at BSI  \n32 Additional resources  \n3 The Clinical Evaluation Plan  \n6 The Clinical Evaluation Report  \n18 The PMS & the PMCF  \n21 Additional documentation and procedures applicable to certain classes of medical devices  \nAuthors/contributors:  \nJane Cains, RGN BSc (Hons), Clinical Training Lead  \nNicholas Harbord-Smith, RN MNursSci, Clinical Evaluation Specialist – Active Implantable Medical Devices  \nRichard Holborow, BSc (Hons) MSCSTRCCP, Global Head of Clinical Compliance  \nKevin Holochwost, Principle Technical  \nSpecialist & Scheme Manager – Active Devices  \nAdam Liddle, PhD, Clinical Regulatory Lead – Orthopaedic & Dental Devices  \nSimon Lidgate, PhD, Technical Team Manager – Active Implantable Medical Devices  \nRachel Mead, BEng (Hons) MIET, Clinical Regulatory Lead – Active Devices  \nAnna Varlese, M.S., Technical Team Manager – Active Devices  \nSheila Walsh, BSc (Hons), Clinical Regulatory Lead – Vascular Devices  \nBest Practice Guidance ©BSI 2026. All rights reserved.  \nScope  \nThis document covers the legislative aspects associated with clinical evaluation under Regulation (EU) 2017/745 (MDR) from a Notified Body perspective. The document doesn't describe how a clinical evaluation should be performed for individual device technologies or classifications, however it guides manufacturers on best practice related to the development of their clinical evaluation documentation under the MDR.  \nGeneral considerations for submissions  \nUpdate frequencies and alignment of documentation  \nManufacturers may need to apply different cadences for updating documents within the technical file, potentially leading to their misalignment. It is vitally important to ensure that information is consistent between all  \ndocuments submitted to the Notified Body as part of the conformity assessment. If the Notified Body observes that,(e.g., device details, specifications, or claims differ between documents), then the manufacturer will likely be challenged on this.  \nThe clinical evaluation documentation, includingthe clinical evaluation report, requires its update frequency to be defined and justified. It is important to consider, at the time of submitting documentation to the Notified Body for conformity assessment, whether the predefined update frequency of documents is appropriate considering, for example, the classification and the risk profile of the device, combined with the level of research activity within the technical and/or medical field.  \nIt is normally expected that clinical evaluation documentation is updated immediately prior to its submission for assessment. Updates are required whenever relevant new information is identified.¹  \nFinal versions of documents  \nManufacturers must always submit the final versions of documents to the Notified Body for conformity assessment. These should be versioncontrolled and signed as approved by all relevant stakeholders prior to being submitted. Evidence of electronic signatures is accepted by the Notified Body. If documents are updated after their submission, but prior to their assessment by the Notified Body, then the manufacturer should make efforts to inform their Scheme Manager.  \n1 MEDDEV 2.7/1 rev 4 Section 6.2.3  \nBest practice Guidance ©BSI 2026. All rights reserved. 1  \nClarity of regulatory pathway: the clinical route to conformity Manufacturers have options in terms of how they collect the clinical data2 they require to support the performance and safety of the device.  \nThe default position, according to the MDR, is that all medical devices require clinical data to support the GSPRs relating to performance and safety. Clinical data should be generated by means of properly designed clinical investigations of the d","cbCaibUw5W1EjCx2","https://ap.wps.com/l/cbCaibUw5W1EjCx2","pdf",2397686,35,"English","# Scope\n## General considerations for submissions\n## The clinical evaluation documentation\n# The Clinical Evaluation Plan\n## The Clinical Evaluation Report\n# The PMS & the PMCF\n## Additional documentation and procedures","[{\"question\":\"What is the document’s scope regarding clinical evaluation submissions to a Notified Body?\",\"answer\":\"It covers legislative aspects of clinical evaluation under Regulation (EU) 2017/745 (MDR) from a Notified Body perspective, guiding manufacturers on best practices for developing clinical evaluation documentation.\"},{\"question\":\"How should manufacturers handle update frequency and document alignment before submission?\",\"answer\":\"Manufacturers should ensure consistency across all documents submitted to the Notified Body and define and justify the update frequency for the clinical evaluation documentation, including the clinical evaluation report.\"},{\"question\":\"Why is a Clinical Evaluation Plan (CEP) critical before creating the Clinical Evaluation Report (CER)?\",\"answer\":\"A good clinical evaluation starts with a well-defined CEP; without it, the CER may fail to meet MDR requirements and can lead to challenges or refusal during conformity assessment.\"}]","Best Practice Guidance - For the Submission of Clinical Evaluation Documentation for Conformity Assessment by the Notified Body | PDF",1790114417]