{"id":829,"date":"2019-11-13T05:21:55","date_gmt":"2019-11-13T05:21:55","guid":{"rendered":"http:\/\/guires.uk\/newsroom\/?p=829"},"modified":"2019-11-18T06:09:59","modified_gmt":"2019-11-18T06:09:59","slug":"importance-of-systematic-literature-search-for-clinical-evaluation-ce-strict-adherence-of-meddev-2-71-rev-4","status":"publish","type":"post","link":"https:\/\/guires.uk\/newsroom\/blog\/importance-of-systematic-literature-search-for-clinical-evaluation-ce-strict-adherence-of-meddev-2-71-rev-4\/","title":{"rendered":"Importance of Systematic literature search for clinical evaluation (CE) \u2013 Strict Adherence of MEDDEV 2.71 Rev 4"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Clinical\nEvaluation Report (CER) comprises of three major parts that present complete\nclinical evaluation information of the medical device under consideration. The\nfirst section is a report of the new clinical investigations of the device\nconducted by the manufacturer. The second section deals with the unpublished\ndata concerning the biological safety and bench testing of the medical device along\nwith compliance and experience records. The third part of the CER deals with\nthe literature review of the clinical evaluation published on equivalent\ndevices.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">&nbsp;A literature review may form the major source of clinical evidence to validate the safety and performance of the established devices in their commercialization approval process, where it may not be feasible to conduct new clinical investigations on the device. <\/p>\n\n\n\n<h3 class=\"h3color\">Purpose of Literature search in Clinical evaluation<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">A\nwell-conducted literature search can reduce the need for generating relevant\ndata through clinical investigation of the medical device under consideration. Therefore,\na good database search knowledge is mandatory (e.g. MEDLINE or Pubmed, EMBASE,\nExcerpta Medica, the Cochrane Central Trials registries, WHO International\nClinical Trial Registry Platform (ICTRP) and Clinical Trials.gov) Experts who\nare well versed in conducting systematic review would adopt sound non-biased\nmethodology using PICO or PRISMA or MOOSE guidelines to review methods\npertinent to the literature review questions.&nbsp;\n&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The\nimportant objectives of the literature review are to <\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Provide an overview of the\nperformance and intended use of the device through a report of past clinical\ntrials.<\/li><li>Establish that the\nparticular medical device is broadly similar to another equivalent device in\nthe market<\/li><li>Validate that the safety\nparameters of the device under the close monitoring of the clinical\ninvestigator<\/li><li>Establish that the\nparticular device is highly safe for use in the day-to-day healthcare delivery\nfield.<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The\nclinical evaluation plan needs to specify the selection criteria of the\nrelevant publications to tackle &nbsp;the\nliterature review questions. It shall contain a decisive review of the\npertinent scientific literature along with the list of literature reviewed and\nrelevant unpublished data about the particular medical device. A good review of\nappropriate literature relating to the intended use and planned method of use\nof the medical device is considered significant by the concerned regulatory\nauthorities during the conformity assessment process.<\/p>\n\n\n\n<h3 class=\"h3color\">European Regulatory guidelines on Literature Review<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The\nEuropean Commission provides a series of guidance documents to assist medical\ndevice manufacturers and other stakeholders in implementing the set directives\nrelated to marketing medical devices in the European Union region.&nbsp; Revision 4 of the guidelines provides\ndetailed information regarding the literature review process for clinical\nevaluation that includes the directions and the methods to do a relevant\nliterature search, appraisal and search strategies.&nbsp; The CER needs to have the analysis of data\narrived from literature review, results of assessment strategy and the\nfunctional list of publication references used in the literature search for\nclinical investigation.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">European\nRegulatory Framework has established that a well-conducted literature review is\nsignificant to <\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Ascertain whether a clinical\ninvestigation is needed for the medical device under consideration.<\/li><li>Make a justification for the\nclinical study, if considered necessary.<\/li><li>Arrive at a conclusion as to\nwhether the particular medical device is ready for commercialization.<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">A\nprofessional literature search conducted with the use of biomedical literature\ndatabase that contains up-to-date and deeply indexed information can lead to a\ncomprehensive report, which has complete information relating to the comparison\nof similar devices, device economics, and adverse device events. The medical\ndevice manufacturers can acquire expert assistance from seasoned professionals\nto create a comprehensive Clinical Evaluation Report that will facilitate them\nto obtain regulatory approval in a prompt manner.<\/p>\n\n\n\n<p class=\"pcontact\">Contact us for more information about how we can help you to develop CER report.  <\/p>\n","protected":false},"excerpt":{"rendered":"<p>Clinical Evaluation Report (CER) comprises of three major parts that present complete clinical evaluation information of the medical device under consideration. The first section is a report of the new clinical investigations of the device conducted by the manufacturer. The second section deals with the unpublished data concerning the biological safety and bench testing of [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":856,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[53],"tags":[],"class_list":["post-829","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"_links":{"self":[{"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/posts\/829","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=829"}],"version-history":[{"count":4,"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/posts\/829\/revisions"}],"predecessor-version":[{"id":889,"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/posts\/829\/revisions\/889"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/media\/856"}],"wp:attachment":[{"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/media?parent=829"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/categories?post=829"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/tags?post=829"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}