{"id":839,"date":"2019-11-13T05:57:05","date_gmt":"2019-11-13T05:57:05","guid":{"rendered":"http:\/\/guires.uk\/newsroom\/?p=839"},"modified":"2019-11-18T06:38:57","modified_gmt":"2019-11-18T06:38:57","slug":"who-should-perform-clinical-evaluations-the-experience-and-expertise-of-cer-authors-and-evaluators","status":"publish","type":"post","link":"https:\/\/guires.uk\/newsroom\/blog\/who-should-perform-clinical-evaluations-the-experience-and-expertise-of-cer-authors-and-evaluators\/","title":{"rendered":"Who should perform clinical evaluations? \u2013 The Experience and expertise of CER authors and Evaluators"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Revised European guidance for medical devices have included\ncomprehensive considerations relating to risk management, post-market\nsurveillance and has introduced many pre and post-market clinical investigation\nrequirements. The objective of the revised guidance is to facilitate the\nmedical device manufacturers in the planning and implementation of robust and\nsystemic clinical evaluation process and the compilation of technically valid\nClinical Evaluation Reports (CERs). The guidance also includes the necessary\nqualification requirements for the authors and evaluators to perform clinical\nevaluations.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u00a0Experts in this specialized field recognize that many medical device manufacturers receive nonconformities mainly because the concerned evaluators are not adequately qualified or their qualifications were not supported with necessary documentation. Clause 6.4 of the revised MEDDEV 2.7.1 Rev 4 prescribes stricter eligibility requirements for report authors and clinical evaluators. It contains details of the essential qualifications and the supporting documentation procedures needed for medical device companies to perform clinical evaluations. <\/p>\n\n\n\n<h3 class=\"h3color\">Important Qualification requirements of a Clinical Evaluator<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">As per the revised guidelines, each evaluator involved in\nthe clinical evaluation process needs to be a qualified individual with\nsufficient knowledge of clinical study design, biostatistics, current\nregulatory requirements, information technology management and medical writing\nskills. The evaluator team and each evaluator need to have adequate technical\nand functional knowledge specific to the medical device under evaluation,\ntechnological know-how and operational proficiency.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The device manufacturer needs to document all the\nqualifications set by the company properly, and the concerned manufacturer also\nneeds to submit a declaration of interest for each evaluator involved in the\nclinical investigation.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Revised European guidance requires the clinical evaluators\nto possess the following training and experience in their area of\nspecialization<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>A higher education degree in their respective\nfield and five years of documented professional experience in the relevant\nfield; or<\/li><li>Ten years of documented professional experience\nin case if the higher education degree is not be taken into consideration for\nthe proposed clinical evaluation of the medical device. <\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The manufacturer needs to take into account the following\nconsiderations to maximize the conformity to the prescribed qualification\nrequirements of the revised European guidance related to medical devices<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>The quantity and\nquality of the evaluators are in line with the nature, clinical performance\nand&nbsp; the associated risks of the medical\ndevice under evaluation <\/li><li>Proper\njustification from the manufacturer regarding the choice of evaluators\nfor clinical evaluation based on the training qualifications and documented\nprofessional experience<\/li><li>Declaration of\ninterest from the evaluators needs to have sufficient clarification relating to\ntheir individual financial interests and conflict of interest in\nundertaking the clinical evaluation.<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">In circumstances where the expertise level of the evaluators\nmay be less or vary from the prescribed guidance, the manufacturers need to be\nappropriately documented and have to present proper justifications for such\ndeviations.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Professional scientific service providers with a network of renowned medical specialists and biostatisticians meet the high requirements of the revised European guidance on authors and evaluators of clinical evaluation. Their experience and expertise in research techniques can be of great assistance to the medical device manufacturers in conducting a well-documented clinical evaluation and in the creation of comprehensive clinical evaluation report.<\/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 clinical evaluations.\n<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Revised European guidance for medical devices have included comprehensive considerations relating to risk management, post-market surveillance and has introduced many pre and post-market clinical investigation requirements. The objective of the revised guidance is to facilitate the medical device manufacturers in the planning and implementation of robust and systemic clinical evaluation process and the compilation of [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":852,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[53],"tags":[],"class_list":["post-839","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\/839","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=839"}],"version-history":[{"count":3,"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/posts\/839\/revisions"}],"predecessor-version":[{"id":896,"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/posts\/839\/revisions\/896"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/media\/852"}],"wp:attachment":[{"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/media?parent=839"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/categories?post=839"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/tags?post=839"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}