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It explains how to justify update frequency based on design or manufacturing changes, emerging risks and uncertainties, innovation and science developments, and confidence in existing data. It further clarifies key MDR provisions including PSUR reporting, SSCP content and public availability, and conditions when clinical investigations are required.",{"@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":51,"@type":70,"position":76},"https://docshare.wps.com/template/general/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/mdr-meddev-v4-medical-devices-regulation-clinical-evidence-requirements/253972/",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/mdr-meddev-v4-medical-devices-regulation-clinical-evidence-requirements/253972.png","ImageObject",442,249,{"name":88,"@type":89},"Chumphorn","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-09-20","2026-09-13",true,{"@type":98,"interactionType":99,"userInteractionCount":76},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"How is the update frequency for the Clinical Evaluation Report (CER) defined under MedDev 2.7.1 Clause 6.2.3?","Question",{"text":108,"@type":109},"The manufacturer defines and justifies how often the CER must be actively updated, considering design or manufacturing changes, medium/long-term risks and uncertainties, innovation and scientific changes, and confidence in evaluation results from clinical and post-market data.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"What must be included in the MDR Periodic Safety Update Report (PSUR) under Article 86?",{"text":113,"@type":109},"The PSUR must present outcomes of PMS/PMCF and any CAPAs, sales volume details including population size and usage frequency where practicable, and conclusions of the risk-benefit analysis. Reporting requirements vary by device class and timing.",{"name":115,"@type":106,"acceptedAnswer":116},"What information must be included in the MDR Summary of Safety and Clinical Performance (SSCP) under Article 32?",{"text":117,"@type":109},"The SSCP must include manufacturer and SRN, device and UDI-DI, intended purpose and related statements, description and variants, possible alternatives, harmonised standards, a summary of the CER plus PMCF, training profile, residual risks and warnings. It is required for implantable and/or class III devices and made public via EUDAMED.","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},253972,1789272461,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":50,"category_name":51,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":76,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":37,"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":20},2336475401981,"https://ap-avatar.wpscdn.com/avatar/22000c94efd8d5204d?x-image-process=image/resize,m_fixed,w_180,h_180&k=1786935347598174694","MedDev 2.7.1 Rev 4 Medical Devices Regulation  \nClinical Evidence Requirements – Key Changes and Clarifications  \nJaishankar Kutty, Ph.D. August 2017  \nAuthored by: Suzie Halliday, Ph. D.  \nCopyright © 2016 BSI. All rights reserved.  \n1  \nClinical Evidence Requirements  \n1. Frequency of updates to the Clinical Evaluation Report (CER)  \n2. Qualifications of report authors and evaluators  \n3. Specific and measurable objectives for the CER  \n4. Establishing the state of the art  \n5. Scientific validity of data  \n6. Equivalence  \n7. Access to data for equivalent devices  \n8. When is a clinical investigation required?  \n9. Risk-benefit  \n10. Post Market Surveillance (PMS) and Post Market Clinical  \n Follow-up (PMCF)  \n1. Clause 6.2.3  \n2. Clause 6.4  \n3. Clause 7 + Appendix 5  \n4. Clause 8.2  \n5. Clause 9.3.1  \n• Clause 8 + Appendix 5  \n• Clause 9 + Appendix 6  \n• Clause 10 + Appendix 7  \n6. Appendix 1  \n7. Appendix 12.2.3  \n8. Appendix 2  \n9. Appendix 7  \n10. Appendix 12  \n2  \nClinical Evidence – MedDev 2.7.1 & MDR  \n| • the clinical data and clinical evaluation report pertaining to a device |  |\n| --- | --- |\n| Clinical Evidence | • sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s) when used as intended by the manufacturer |\n| Clinical Evaluation | • a systematic and planned /methodologically sound / process to\u003Cbr>continuously generate, collect, analyse and assess the clinical\u003Cbr>data pertaining to a device\u003Cbr>• to verify the safety and performance, including clinical benefits,\u003Cbr>of the device when used as intended by the manufacturer |\n| Clinical Data | • clinical investigation on the device concerned\u003Cbr>• clinical investigation reported in the scientific literature, of a device for which equivalence to the device in question can be demonstrated\u003Cbr>• peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence can be demonstrated\u003Cbr>• clinically relevant information from the manufacturer’s postmarket surveillance system, in particular post-market clinical follow-up |\n|  |  |\n|  |  |\n\n3  \n4  \n1. Frequency of updates to the Clinical Evaluation Report  \nMedDev 2.7.1 – 6.2.3 Updating the clinical evaluation  \na. Frequency of updates  \nThe manufacturer should define and justify the frequency at which the clinical evaluation needs to be actively updated. When doing so, the manufacturer should typically  \nconsider:  \n• design changes or changes to manufacturing procedures (if any)  \n• risks, uncertainties or unanswered questions, in the medium or long term  \n• innovation, changes in clinical sciences, changes in materials sciences  \n• current confidence in the evaluation of clinical safety and performance (data available from clinical investigations, PMCF studies, registries, other systematic studies, total number of devices used in the market, expected reporting rates under the vigilance system)  \n•  \nrisks – design, materials, components, invasiveness, clinical procedures, high-risk anatomical locations, high-risk populations, severity of disease, treatment challenges  \n5  \nMedDev 2.7.1 – 6.2.3 Updating the clinical evaluation  \nThe clinical evaluation is actively updated:  \n• on receipt of new information from PMS that has the potential to change the current evaluation  \n• at least annually if the device carries significant risks or is not yet well established  \n• every 2 to 5 years if the device is not expected to carry significant risks and is well established  \nWhen involvement of notified bodies is required, updates are usually coordinated with the notified body. Typically, they are aligned with the timetable for surveillance audits and the renewal of the certificates.  \n6  \nMDR – Article 86 – Periodic Safety Update Report  \n• Throughout the lifetime of the device concerned the PSUR shall set out:  \n• Outcomes of the PMS/PMCF  \n• Outcomes of any CAPAs  \n• Volume of Sales ","cbCaih3TpqL2vgx2","https://ap.wps.com/l/cbCaih3TpqL2vgx2","pdf",1253214,"English","# Clinical Evidence Requirements\n## Frequency of updates to the Clinical Evaluation Report (CER)\n## Qualifications of report authors and evaluators\n## Specific and measurable objectives for the CER\n## Establishing the state of the art\n## Scientific validity of data\n## Equivalence and access to data\n## When a clinical investigation is required\n## Risk-benefit, PMS and PMCF\n## Key MDR articles: Article 86 PSUR and Article 32 SSCP\n## Article 61 Clinical Evaluation update frequency","[{\"question\":\"How is the update frequency for the Clinical Evaluation Report (CER) defined under MedDev 2.7.1 Clause 6.2.3?\",\"answer\":\"The manufacturer defines and justifies how often the CER must be actively updated, considering design or manufacturing changes, medium/long-term risks and uncertainties, innovation and scientific changes, and confidence in evaluation results from clinical and post-market data.\"},{\"question\":\"What must be included in the MDR Periodic Safety Update Report (PSUR) under Article 86?\",\"answer\":\"The PSUR must present outcomes of PMS/PMCF and any CAPAs, sales volume details including population size and usage frequency where practicable, and conclusions of the risk-benefit analysis. Reporting requirements vary by device class and timing.\"},{\"question\":\"What information must be included in the MDR Summary of Safety and Clinical Performance (SSCP) under Article 32?\",\"answer\":\"The SSCP must include manufacturer and SRN, device and UDI-DI, intended purpose and related statements, description and variants, possible alternatives, harmonised standards, a summary of the CER plus PMCF, training profile, residual risks and warnings. It is required for implantable and/or class III devices and made public via EUDAMED.\"}]","MDR-MEDDEV-v4 - Medical Devices Regulation - Clinical Evidence Requirements | PDF"]