{"id":48337,"date":"2022-09-07T13:53:54","date_gmt":"2022-09-07T08:23:54","guid":{"rendered":"https:\/\/corpbiz.io\/learning\/?p=48337"},"modified":"2022-09-07T13:53:56","modified_gmt":"2022-09-07T08:23:56","slug":"clinical-performance-evaluation-for-new-ivd-medical-device","status":"publish","type":"post","link":"https:\/\/corpbiz.io\/learning\/clinical-performance-evaluation-for-new-ivd-medical-device\/","title":{"rendered":"Clinical Performance Evaluation for New IVD Medical Device"},"content":{"rendered":"\n<p>CDSCO or <strong>Central Drugs Standard Control Organisation<\/strong><sup><a href=\"https:\/\/en.wikipedia.org\/wiki\/Central_Drugs_Standard_Control_Organisation\"><strong>[1]<\/strong><\/a><\/sup>, is a regulatory body which functions as a Central Licensing Authority (CLA) that provides  the permission required for Clinical Performance Evaluation (CPE) for New In-Vitro Diagnostic Medical Devices. In this write-up, we are going to discuss Clinical Performance Evaluation for new IVD Medical Device. c<\/p>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_82_2 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title ez-toc-toggle\" style=\"cursor:pointer\">Page Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 eztoc-toggle-hide-by-default' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/corpbiz.io\/learning\/clinical-performance-evaluation-for-new-ivd-medical-device\/#What_are_In-Vitro_Diagnostics_IVDs_Medical_Devices\" >What are In-Vitro Diagnostics (IVDs) Medical Devices?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/corpbiz.io\/learning\/clinical-performance-evaluation-for-new-ivd-medical-device\/#What_are_Form_MD-24_and_MD-25\" >What are Form MD-24 and MD-25?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/corpbiz.io\/learning\/clinical-performance-evaluation-for-new-ivd-medical-device\/#Conditions_for_Conducting_Clinical_Performance_Evaluation\" >Conditions for Conducting Clinical Performance Evaluation<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/corpbiz.io\/learning\/clinical-performance-evaluation-for-new-ivd-medical-device\/#Documents_Required_to_Obtain_Permission_to_Conduct_Clinical_Performance_Evaluation\" >Documents Required to Obtain Permission to Conduct Clinical Performance\nEvaluation<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/corpbiz.io\/learning\/clinical-performance-evaluation-for-new-ivd-medical-device\/#Procedure_to_Obtain_Clinical_Performance_Evaluation_for_IVD_Medical_Device\" >Procedure to Obtain Clinical Performance Evaluation for IVD Medical Device<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/corpbiz.io\/learning\/clinical-performance-evaluation-for-new-ivd-medical-device\/#Important_Tips_for_Conducting_Clinical_Performance_Evaluation_for_IVD_Medical_Devices\" >Important Tips for Conducting Clinical Performance Evaluation for IVD\nMedical Devices<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/corpbiz.io\/learning\/clinical-performance-evaluation-for-new-ivd-medical-device\/#Conclusion\" >Conclusion<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_are_In-Vitro_Diagnostics_IVDs_Medical_Devices\"><\/span>What are In-Vitro Diagnostics (IVDs) Medical Devices?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>IVD products are\ndevices &amp; systems used to treat, prevent, or diagnose health conditions.\nThese products are meant to be used in the collection &amp; examination of\nbiological samples such as tissue, blood, or saliva. An IVD device could be a\nregent, software, test kit, system, or instrument.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"What_are_Form_MD-24_and_MD-25\"><\/span>What are Form MD-24 and MD-25?<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<ol><li><strong>MD-24<\/strong> is an application form to grant permission to conduct a CPE.<\/li><li><strong>MD-25:<\/strong> It is the permission to conduct a CPE of a new\nIn-vitro Diagnostics medical device (IVD).<\/li><\/ol>\n\n\n\n<p><strong><em>Note: Any manufacturers or\nimporters who want to conduct a clinical evaluation of new IVD can make an\napplication form to the CLA.<\/em><\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conditions_for_Conducting_Clinical_Performance_Evaluation\"><\/span>Conditions for Conducting Clinical Performance Evaluation<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following are some conditions for Clinical Performance Evaluation:<\/p>\n\n\n\n<ul><li>The\nClinical Investigation plan needs to be approved through registration with the\nClinical Trial Registry of India.<\/li><li>The\nClinical Evaluation needs to be conducted per the approved clinical evaluation\nplan &amp; good clinical practice guidelines granted by the CDSCO.<\/li><li>The\nanalysis should be initiated within one year of getting the permission failing\nthat, prior permission is required to start the analysis.<\/li><li>The\nsponsor should submit the annual report of the analysis to the Central\nLicensing Authority (CLA), and if the study is terminated, it should be\nreported within thirty days.<\/li><li>The\nsponsor and any person connected with the study are subjected to an audit by\nthe authorised officers of the CLA.<\/li><li>Any\nadditional exemptions or conditions, in case any, imposed through CLA while\ngranting the permission must be followed through the sponsor.<\/li><li>If there\nis any injury to the subjects, the sponsor has to provide medical facilities to\nthe subject.<\/li><li>In case\nthe sponsor fails to comply with the permission conditions, the CLA may suspend\nor cancel the permission either partly or wholly. The sponsor may appeal\nagainst such orders to the Central Government within thirty days, and the\ngovernment will dispose of such appeal within sixty days.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Documents_Required_to_Obtain_Permission_to_Conduct_Clinical_Performance_Evaluation\"><\/span>Documents Required to Obtain Permission to Conduct Clinical Performance\nEvaluation <span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following are some vital documents necessary to obtain permission to conduct a Clinical Performance Evaluation for a New IVD Medical Device:<\/p>\n\n\n\n<ul><li>Complete\nMedical Device Description;<\/li><li>Performance\nevaluation report by Central Device Testing Lab;<\/li><li>In House\nPerformance evaluation data;<\/li><li>Performance\nevaluation plan;<\/li><li>Case\nreport form &amp; undertaking as prescribed in the seventh schedule;<\/li><li>Approval\nthrough the registered Ethics Committee;<\/li><li>Quantity\n&amp; Source of sample;<\/li><li>Duration\nof evaluation;<\/li><li>Laboratories\nparticipating in the study and undertaking that the medical device conforms to\nthe rules &amp; adequate precaution has been taken to protect the health &amp;\nsafety of the subjects.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Procedure_to_Obtain_Clinical_Performance_Evaluation_for_IVD_Medical_Device\"><\/span>Procedure to Obtain Clinical Performance Evaluation for IVD Medical Device<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The permission to conducting of Clinical Performance Evaluation (CPE) for a new IVD medical device can be obtained through a sponsor by submitting an application Form MD-24 to the Central Licensing Authority (CLA) and submitting required essential documents and a fee prescribed in the Second Schedule of MDR, 2017. In case the application form complies with the statutory requirements, then the CLA will issue the approval in Form MD-25 or else, the application form will be rejected within ninety days from the date of application after allowing an explanation. No fees are required in case the organisation, institute, or hospital is run or funded through the Central Government or the State Government. In the public interest, the CLA has the authority to defer, abbreviate, and waive the requirement of CPE.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Important_Tips_for_Conducting_Clinical_Performance_Evaluation_for_IVD_Medical_Devices\"><\/span>Important Tips for Conducting Clinical Performance Evaluation for IVD\nMedical Devices<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Following are some\nimportant tips for conducting Clinical Performance Evaluation for IVD Medical\nDevices:<\/p>\n\n\n\n<ul><li>The\nApplicant needs to have an undertaking from investigators.<\/li><li>The\nClinical Performance Evaluation plan should clearly state the objective,\nscientific, medical or technical grounds and scope of the evaluation.<\/li><li>The\nApplicant needs approval from an Ethics Committee registered with the CLA.<\/li><\/ul>\n\n\n\n<p><strong>The same issues can be faced in case the\nfollowing points are left unchecked during the application procedure:<\/strong><\/p>\n\n\n\n<ul><li>The\nApplicant must register the Clinical Evaluation with the Clinical Trial\nRegistry of India before enrolling the 1<sup>st<\/sup> participant for the\nClinical Evaluation.<\/li><li>The\nClinical Evaluation plan needs to be initiated only after the registered Ethics\nCommittee approves.<\/li><li>The\nClinical Evaluation should be conducted under the guidelines of Good Clinical\nPractices and the approved Clinical Evaluation Plan.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span>Conclusion<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Clinical data for a particular device are continuously generated, collected, analysed, and evaluated through the systematic and planned process of clinical performance evaluation of medical devices. Additionally, it confirms a device&#8217;s effectiveness and safety, including any clinical benefits, for the manufacturer&#8217;s intended usage. Comparatively to the MDD, the MDR emphasises the extent and weighting of the clinical evaluation. For a device to be certified and given the <a href=\"https:\/\/corpbiz.io\/ce-certification\"><strong>CE mark<\/strong><\/a>, it must undergo a clinical review as part of the development process and adhere to the GSLA&#8217;s Essential Safety and Performance Requirements. As a result, every manufacturer of medical devices must go through this procedure with their product. <\/p>\n\n\n\n<p class=\"text-left\"><b>Read our Article<\/b>:<mark style=\"background: #fffd03 !important;\"><a href=\"https:\/\/corpbiz.io\/learning\/top-differences-between-medical-devices-and-ivds\/\">Top Differences Between Medical Devices and IVDs<\/a><\/mark><\/p>\n","protected":false},"excerpt":{"rendered":"<p>CDSCO or Central Drugs Standard Control Organisation[1], is a regulatory body which functions as a Central Licensing Authority (CLA) that provides the permission required for Clinical Performance Evaluation (CPE) for New In-Vitro Diagnostic Medical Devices. In this write-up, we are going to discuss Clinical Performance Evaluation for new IVD Medical Device. c What are In-Vitro [&hellip;]<\/p>\n","protected":false},"author":42,"featured_media":48341,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[2358],"tags":[2700],"acf":{"service_id":"508"},"authorName":"Krishna Kumar","authorImageUrl":"https:\/\/corpbiz.io\/learning\/wp-content\/uploads\/2022\/07\/MicrosoftTeams-image-62.jpg","authorDescription":"Krishna Kumar has completed BA-LLB with a specialization in constitutional Laws from ICFAI University. As a recent graduate, He has both legal research and content writing experience in various law firms. He secures good drafting skills for various legal documents in multiple fields of law.","postViews":3268,"readingTime":4,"_links":{"self":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48337"}],"collection":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/users\/42"}],"replies":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/comments?post=48337"}],"version-history":[{"count":12,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48337\/revisions"}],"predecessor-version":[{"id":48352,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/posts\/48337\/revisions\/48352"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media\/48341"}],"wp:attachment":[{"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/media?parent=48337"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/categories?post=48337"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/corpbiz.io\/learning\/wp-json\/wp\/v2\/tags?post=48337"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}