{"id":837,"date":"2019-11-13T05:54:18","date_gmt":"2019-11-13T05:54:18","guid":{"rendered":"http:\/\/guires.uk\/newsroom\/?p=837"},"modified":"2019-11-18T06:33:38","modified_gmt":"2019-11-18T06:33:38","slug":"preparing-a-clinical-evaluation-report-cer-for-medical-devices","status":"publish","type":"post","link":"https:\/\/guires.uk\/newsroom\/blog\/preparing-a-clinical-evaluation-report-cer-for-medical-devices\/","title":{"rendered":"Preparing a Clinical Evaluation Report (CER) for medical devices"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">The Clinical Evaluation Report (CER)\nis a prerequisite document required to be submitted to regulatory bodies along\nwith the technical file as a part of CE marking, and conformity assessment\nprocess before the medical device manufacturer introduces the product in the\nEuropean market. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The clinical evaluation report (CER)\nprovides complete details of a medical device product in its entire lifecycle\nand is a mandatory document needed for the European Union market for all types\nof medical devices, components, and compounds. CER document is prepared based\non the clinical evaluation of the medical device and is an important\nrequirement to obtain CE marking. It is an important part of the technical file\nor the design dossier of the medical device manufacturer, and they need to be\nupdated with regular reviews throughout the lifecycle of the device. The CER is\nan important live document that needs to be prepared based on solid foundations,\nevidence, and literature reviews of similar products, components, and\ncompounds.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Manufacturers need to comply with\nEuropean CER requirements that necessitate that the respective device or\ncomponent achieve their intended purpose without exposing the patients,\nconsumers or users to any adverse risk. Clinical data is recognized as the\nnecessary evidence to validate the safety and performance of the medical\ndevices, which is derived by conducting preclinical and clinical assessments,\nscientific literature and the clinical experience of comparable equipment.\nEvaluation and analysis of the clinical data are essential to validate the\nclinical safety and performance of the medical device, which is outlined in the\nClinical Evaluation Report.&nbsp; <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Clinical evaluation is an ongoing and\ncontinuous process that is integrated into the quality system and carried out\nthroughout the life-cycle of the device. The initial report is prepared at the\nbeginning of the CER\u2019s lifecycle and the manufacturers need to update CER based\non ongoing clinical evaluations. The CER can also be updated as the component\nof post-market surveillance and vigilance case review.<\/p>\n\n\n\n<h3 class=\"h3color\">Major components of Clinical Evaluation Report<\/h3>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>&nbsp;&nbsp;<\/strong>&nbsp;&nbsp;Description of the medical device, components\nand model numbers <\/li><li>&nbsp;&nbsp;&nbsp;&nbsp;Intended purpose of the\ndevice <\/li><li>&nbsp;&nbsp;&nbsp;&nbsp;Fundamental principles of\noperation<\/li><li>&nbsp;&nbsp;&nbsp;&nbsp;Indications and supporting\nclaims<\/li><li>&nbsp;&nbsp;&nbsp;&nbsp;Overview of relevant\npre-clinical data<\/li><li>&nbsp;&nbsp;&nbsp;&nbsp;State Compliance to\nstandards like MEDDEV 2.7.1<\/li><\/ul>\n\n\n\n<h3 class=\"h3color\">Relevant Standards and Guidelines for Clinical Evaluation<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\nThe key applicable guidance standards and the\nrespective guidelines are mentioned below;\n\n\n\n<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>MEDDEV 2.7.1 Rev4, an updated version of Rev 3 standard provides the\nEuropean Commission\u2019s Guidelines on Medical Devices, which is a complete guide\nfor manufacturers and regulatory authorities, relating to clinical data\nevaluation.<\/li><li>MEDDEV 2.7.1 Rev3 standard provides the European Commission\u2019s\nGuidelines on Medical Devices, which is a complete&nbsp; guide for manufacturers and regulatory\nauthorities relating to clinical data evaluation.<\/li><li>MEDDEV 2.12-1 Rev8 standard outlines the guidelines on\nmedical device vigilance system.<\/li><li>MEDDEV 2.12\/2 Rev 2 provides the guidelines on medical devices\nrelating to post \u2013market clinical follow-up studies.<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Medical device manufacturers need\nright expertise, and sufficient time to effectively conduct a clinical\nevaluation and subsequently create a clinical Evaluation Report (CER), thus it\nis a major challenge.&nbsp; Hence, many manufacturers\u2019\nhave realized that the clinical evaluation process is not a standalone activity\nbut a relatively continuous process and often seek the assistance of qualified professional\nservice providers with strong expertise and experience to prepare an up to date\nCER.<\/p>\n\n\n\n<p class=\"pcontact\">Contact us for more information about how we can help you comply with MEDDEV 2.7\/1 rev 4 and perform literature reviews.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Clinical Evaluation Report (CER) is a prerequisite document required to be submitted to regulatory bodies along with the technical file as a part of CE marking, and conformity assessment process before the medical device manufacturer introduces the product in the European market. The clinical evaluation report (CER) provides complete details of a medical device [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":850,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[53],"tags":[],"class_list":["post-837","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\/837","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=837"}],"version-history":[{"count":3,"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/posts\/837\/revisions"}],"predecessor-version":[{"id":895,"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/posts\/837\/revisions\/895"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/media\/850"}],"wp:attachment":[{"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/media?parent=837"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/categories?post=837"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/tags?post=837"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}