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It guides the preparation of administrative particulars, executive summary, scope, objectives and hypothesis, device description and intended purpose, clinical evaluation plan, and harmonised standards. 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Users will be held accountable for licence breaches, including recourse to legal remedy.  \nIt must not be reproduced or shared in any way.  \nCopyright remains the property of Mantra Systems Ltd.  \n- --  \nThis document contains guidance only. Mantra Systems Ltd is unable to accept responsibility or liability for any damage resulting from use of this document. The medical device manufacturer retains full responsibility for the structure and content of all regulatory documents, including those produced through reference to the guidance contained in this document.  \nContents  \nIntroduction 5  \n1. Administrative particulars 8  \n2. Executive Summary 9  \n3. Scope of the clinical evaluation 11  \n3. 1. Objective 11  \n3.2. Hypothesis 12  \n3.3. Device overview  12  \n3.4. Device classification 14  \n3.5. Manufacturer and sales history 15  \n3.6. Intended purpose  16  \n3.7. Indications, contraindications and precautions 16  \n3.8. Target population and medical conditions 16  \n3.9. Device composition and components 17  \n3. 10. Accessories or compatible devices 18  \n3. 11. Similar devices  18  \n4. Clinical Evaluation Plan-Summary 19  \n4. 1. Intended purpose, target groups & indications / contra-indications of the device 19  \n4.2. Intended clinical benefits 19  \n4.3. General Safety and Performance Requirements (GSPRs) 20  \n4.4. Type of evaluation 20  \n4.5. Methods used for examining clinical safety  21  \n4.6. Search protocol: evidence identification, appraisal and analysis plan  22  \n4.7. Clinical development plan 37  \n5. Common specifications and harmonised standards 38  \n6. Clinical background, current knowledge, state of the art 39  \n6. 1. Methods and search protocol 39  \n6.2. Objective 40  \n6.3. General description of the medical condition 41  \n6.4. Other available treatment options & comparable alternatives 42  \n6.5. State of the art 45  \n7. Equivalence 46  \n7. 1. Equivalent device(s) 46  \n7.2. Statement of equivalence & access to data 47  \n7.3. Equivalence rationale 47  \n7.4. Equivalence summary 48  \n8. Clinical evidence review 49  \n8. 1. Introduction 49  \n8.2. Clinical review questions 49  \n8.3. Data generated and held by the manufacturer 49  \n8.4. Information from PMS, Vigilance systems & PMCF activities 50  \n8.5. Clinical data from literature 52  \n8.6. Summary of clinical data  54  \n8.7. Summary of safety outcomes 54  \n8.8. Summary of performance outcomes 54  \n9. Clinical Evidence Analysis-GSPRs 55  \n9. 1. Introduction and methodology 55  \n9.2. GSPR conformity analysis 56  \n9.3. GSPR Conformity-conclusion 58  \n10. Clinical evidence analysis-Benefit-risk profile  59  \n10. 1. Risk management system  59  \n10.2. Known risks and acceptability analysis  59  \n10.3. Clinical evidence review- impact of risk analysis 60  \n10.4. Clinical benefits 60  \n10.5. Benefit-risk analysis 61  \n11. Conclusions 62  \n12. Final sections 64  \nIntroduction  \nThe Clinical Evaluation Report (CER) is an important technical document that must be produced in relation to every medical device under the MDR. It documents a point-in-time summary of the ongoing process of medical device clinical evaluation.  \nA clinical evaluation is performed through the objective assessment of all clinical evidence relating to the subject medical device, whether favourable or unfavourable, in order to determine whether a device meets its obligations under the MDR. Specifically, it considers whether evidence supports conformity with all relevant General Safety and Performance Requirements (GSPRs), conformity with the device's intended purpose, anda favourable benefit-risk profile.  \nA CER consists of the following sections:  \n● Administrative ","cbCaips6ggbiK06u","https://ap.wps.com/l/cbCaips6ggbiK06u","pdf",726457,"English","# Contents\n## Introduction\n## 1. Administrative particulars\n## 2. Executive Summary\n## 3. Scope of the clinical evaluation\n## 4. Clinical Evaluation Plan-Summary\n## 5. Common specifications and harmonised standards\n## 6. Clinical background, current knowledge, state of the art\n## 7. Equivalence\n## 8. Clinical evidence review\n## 9. Clinical Evidence Analysis-GSPRs\n## 10. Clinical evidence analysis-Benefit-risk profile\n## 11. Conclusions\n## 12. Final sections\n# How to use this template\n## Required information\n## Instructions\n## Guidance","[{\"question\":\"What is the purpose of a Clinical Evaluation Report (CER) under the EU MDR?\",\"answer\":\"A CER provides a point-in-time summary of the ongoing clinical evaluation process and documents the assessment of all clinical evidence. It supports determining whether the device meets MDR obligations, including GSPR conformity and a favourable benefit-risk profile.\"},{\"question\":\"What sections does the CER template include?\",\"answer\":\"The template covers administrative particulars, executive summary, hypothesis and objectives, device description and classification, clinical field summary, the clinical evaluation plan, common specifications and harmonised standards, equivalence (if relevant), and evidence review and analyses. It ends with conclusions and final sections such as revision dates and author CVs.\"},{\"question\":\"How does the template guide clinical evidence review and analysis?\",\"answer\":\"It specifies an objective, systematic literature review with a defined identification and appraisal plan, including both manufacturer-held information and external/independent data. It then analyses conformity with relevant GSPRs and performs benefit-risk profiling using a structured risk management view of known risks and clinical benefits.\"}]","Clinical Evaluation Report Template - Edition 4.0 - EU MDR-compliant CER toolkit | PDF",1789225029,6]