{"id":450,"date":"2019-11-08T09:55:51","date_gmt":"2019-11-08T09:55:51","guid":{"rendered":"http:\/\/guires.uk\/newsroom\/?p=450"},"modified":"2019-11-18T06:31:20","modified_gmt":"2019-11-18T06:31:20","slug":"a-clinical-evaluation-report-cer-that-complies-with-meddev-2-7-1-rev-4-guidelines-a-case-of-x-ray-and-ecg","status":"publish","type":"post","link":"https:\/\/guires.uk\/newsroom\/case-studies\/a-clinical-evaluation-report-cer-that-complies-with-meddev-2-7-1-rev-4-guidelines-a-case-of-x-ray-and-ecg\/","title":{"rendered":"A Clinical Evaluation Report (CER) that complies with MEDDEV 2.7.1. Rev 4 Guidelines: A Case of X-Ray and ECG"},"content":{"rendered":"\n<p class=\"lead wp-block-paragraph\">A leading &nbsp;&nbsp;international healthcare technology company\nspecialising in High-Frequency X-Ray Imaging Systems, Critical Care, Dental\nCare, Primary Healthcare &amp; Telemedicine devices. The company&#8217;s vision is to\naid Primary Healthcare with products of International quality and performance\nat an affordable level to the rural population throughout the world. The\ncompany does that by combining the latest in technology with the simplicity of\ndesign, innovation and high performance for efficient patient care. The\ncompany\u2019s products are designed to comply with international quality &amp;\nsafety standards such as UL, CE, FDA, ISO 13485, ISO 9001 and AERB. The Company approached us to provide complete CER\nReport Evaluation and Writing.&nbsp; <\/p>\n\n\n\n<h3 class=\"h3color\">The Challenges<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The company sells their\nmedical devices in Europe and to comply with regulations, a Clinical Evaluation\nReport (CER) that complies with MEDDEV 2.7.1. Rev 4 Guidelines the client\napproached Pepgra, a Unit of Guires Ltd for updating and preparation of Clinical\nevaluation report for CE Marking from Revision 3 guidelines to MEDDEV guideline\n2.7.1 [Revision 4] (June 2016). The clinical evaluation report is developed to\nmeet the requirements of MDD\/93\/42\/EEC and framework as per MEDDEV 2.7.1. Rev 4\nGuidelines. The initial report shared by the client was with 5-10 pages and didn\u2019t\ncover all the requirements as per the MEDDEV guidelines. We discussed with the\nclient about the new revision and provided following understanding of the work\nthat needed to be carried out to adhere to the recent guidelines. &nbsp;<\/p>\n\n\n\n<ol>\n\t<li>Literature Search Flow Chart<\/li>\n    <li>Bibliographic Search Flow Chart<\/li>\n        <li> Screening the articles for inclusion and exclusion criteria (Primary &amp; Bibliographic),<\/li>\n        <ol>\n            <li>Primary Search Title Screening Summary<\/li>\n                <li>Bibliographic Title Screening Summary<\/li>\n                    <li>Primary Search Abstract &amp; Full Text Screening Summary<\/li>\n                        <li>Bibliographic Abstract &amp; Full Text Screening Summary <\/li><\/ol>\n                        <li>Data Extraction of finally included articles<\/li>\n<li>Data Appraisal of Clinical Data [A6] <\/li>\n<li>Analyses of the Clinical data [A7]<\/li>\n<li>Data Interpretation<\/li>\n<li>Conformity assessment with the requirement on Safety [A7.1]<\/li>\n<li>Conformity assessment with the requirement on Acceptable benefit\/risk profile [A7.2]<\/li>\n<li>Conformity assessment with the requirement on performance [A7.3]<\/li>\n<li>Conformity assessment with the requirement on Undesirable Side effects [A7.4]<\/li>\n<li>Conclusion <\/li>\n<li>Annexure I \u2013 Citation details<\/li>\n<li>Annexure-II \u2013 Device Description Per Study Details <\/li>\n<li>Annexure III \u2013 Study details <\/li>\n<li>Annexure-IV \u2013 Study Outcome <\/li>\n<\/ol>\n\n\n\n<h3 class=\"h3color\">Our Strategy<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Since Pepgra specialises in\nreviewing medical device clinical data and ensure that CER meets all European\nrequirement, our team of Medical device experts had developed\nthe clinical evaluation report set for the manufacturers and notified bodies\nunder directives 93\/42\/EEC and 90\/385\/EEC. The report is fully compliant with &nbsp;<a href=\"C:\/\/Users\/ganes\/Downloads\/2_7_1_rev4_en.pdf\">MEDDEV 2.7\/1 Rev 4<\/a>. Since its a\ntransition from old to new, the\nkey changes and clarifications in the new guidelines MEDDEV 2.7.1 Rev 4 have\nbeen discussed and addressed. For instance, <\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Clause\n6.2.3<\/strong>\nrequires the CER to be updated at least annually for high risk of new devices,\nand every 2 to 5 years for lower risks. A justification for the update\nfrequency will be required. &nbsp;<\/li><li><strong>Clause 6.4<\/strong>\nmandates to report qualifications of authors and evaluators, including a\nrelevant higher education degree and five years or ten years\u2019 experience. All\nevaluators must now make a declaration of interest<\/li><li>Specific and measurable objectives of the CER in\nterms of safety, performance and risk endpoints related to the essential\nrequirements to be mentioned clearly. <\/li><li><strong>Clause 8.2<\/strong>\nmandates companies to establish state of the art including establishment of the\ndevice, its claimed equivalent(s) and any benchmark or other similar devices,\nits claimed equivalent(s) and any similar devices<\/li><li><strong>Section 9.3.1<\/strong>\naddresses factors which can affect scientific validity of different types of\ndatasets including literature search and retrieval methods (Section 8 and\nAppendix 5), data appraisal and weighting (Section 9 and Appendix 6), and the\nanalysis of data and demonstration of conformity (Section 10 and Appendix 7)<\/li><li><strong>Revision 4 <\/strong>requires\nequivalence specifically mentioning the design differences and their impacts on\nclinical safety and performance which needs to be described in detail<\/li><li>Revision 4 also requires that the Notified Body\nchallenge the manufacturers access to data and therefore will require a manufacturer\nto have a contract in place allowing access to data<\/li><li>&nbsp;Sufficient\ndata on <strong>the clinical device<\/strong> <\/li><li><strong>Appendix 7 Risk-benefit analysis<\/strong> to demonstrate safety and performance. <\/li><li>Post Market Surveillance (PM) and Post Market\nClinical Follow Up (PMCF) <\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Our team of experts visited the site, collected all manuals to understand the technical requirements of the product. Several discussions were carried out to complete the report, and with ten iterations, the report was successfully prepared and delivered. <\/p>\n\n\n\n<h3 class=\"h3color\">Our Outcome and Impact<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The literature\nsearch is being carried out to identify published clinical data that helps to\nassist manufacturers in establishing acceptable performance and safety\nstandards for the pertinent device, i.e., Mobile C-Arm Surgical X-Ray System.\nThe data generated through the literature search is directly related to the\ndevice or the equivalent device. While conducting a literature review, reasonable\neffort is made to conduct a comprehensive and exhaustive search, and the\npublished data is thereby selected and evaluated judiciously, based on the\nprinciple of contribution towards the device, in terms of both performance and\nsafety against the risks. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Pepgra specializes in\nreviewing medical device clinical data.Contact us for more information about\nhow we can help you comply with MEDDEV 2.7\/1 rev 4 and perform literature\nreviews.<strong><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A leading &nbsp;&nbsp;international healthcare technology company specialising in High-Frequency X-Ray Imaging Systems, Critical Care, Dental Care, Primary Healthcare &amp; Telemedicine devices. The company&#8217;s vision is to aid Primary Healthcare with products of International quality and performance at an affordable level to the rural population throughout the world. The company does that by combining the latest [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":803,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-450","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-case-studies"],"_links":{"self":[{"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/posts\/450","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/comments?post=450"}],"version-history":[{"count":7,"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/posts\/450\/revisions"}],"predecessor-version":[{"id":894,"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/posts\/450\/revisions\/894"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/media\/803"}],"wp:attachment":[{"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/media?parent=450"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/categories?post=450"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/tags?post=450"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}