European regulatory framework has\nestablished rules that govern the development, manufacturing, and marketing of medical\ndevices in the European market. Both European and non-European medical device\nmanufacturers fall under the purview of the regulatory framework, which is\nestablished to provide confidence to the clinicians, and the patients that the\nmedical and implantable devices used in the region have been validated for\ntheir potential benefits and certified as safe for usage. The European\nregulatory framework\u2019s MEDDEV guidelines promote a uniform approach to the\nconformity assessment procedures for the medical device manufacturers and the\nnotified bodies associated with the evaluation process. MEDDEV 2.7.1 Rev 4\nguidelines provide guidance relating to the proper evaluation of clinical\nsafety and the performance of the medical devices for the manufacturers. <\/p>\n\n\n\n
Clinical Evaluation Report (CER) is\nan important document that is a part of the conformity assessment process,\nwhich is carried out throughout the life-cycle of the device. The CE reports\nprovide conclusive information about the clinical safety and the performance of\nthe medical device by bringing together all relevant clinical data and making proper\nanalysis of the data.<\/p>\n\n\n\n
Clinical evaluation is undertaken in\nthe initial phase of the conformity assessment, which is conducted for the\npurpose of obtaining CE mark, the marketing license to market the products in\nthe European Union region. <\/p>\n\n\n\n
The CE report needs to be revised periodically to update the concerned authorities whenever the manufacturers have made changes to the device\u2019s design, manufacturing process or its intended use. The CER is also needed to inform the authorities about the risk analysis of the device, which is done to identify potential risks and areas of concern, and to update them on the risk mitigation measures undertaken by the manufacturers.<\/p>\n\n\n\n
In the post-market phase, clinical evaluation of the device is continued with the maintenance of surveillance programs to monitor device safety and performance. The updated CER can include adverse incident reports, results from published literature reviews on the actual device or similar products, and clinical investigations.<\/p>\n\n\n\n
The medical device\u2019s clinical data\ncollected during the pre-market phase may be too limited and might not be\nsufficient to identify events or incidents with rare occurrence. Post Market\nClinical Follow-up involves an ongoing collection of clinical data based on the\nuser experience of the device after its introduction in the market. Regulatory\nrequirements mandate medical device manufacturers to conduct Post Market\nSurveillance plan that includes PMCF with the objective of identifying new\nrisks that cannot be predicted during the pre-market phase. The manufacturers\nneeds to analyze the clinical data obtained from the PMCF to arrive at\nmeaningful conclusions about the benefits and the risks of the device. They also\nhave to report the current understanding to the relevant authorities in CER on\na periodic basis.<\/p>\n\n\n\n
CE report is needed to update the\nresults of the Post-market Clinical follow-up along with the vigilance and\ncomplaints to comply with the regulatory requirements. <\/p>\n\n\n\n
Thus, CE Report is an important\nprerequisite for introducing and continuing to market medical devices in\nEuropean Union regions, which requires high expertise and sufficient time\nallocation for initial preparation and subsequent updating process. <\/p>\n","protected":false},"excerpt":{"rendered":"
European regulatory framework has established rules that govern the development, manufacturing, and marketing of medical devices in the European market. Both European and non-European medical device manufacturers fall under the purview of the regulatory framework, which is established to provide confidence to the clinicians, and the patients that the medical and implantable devices used in […]<\/p>\n","protected":false},"author":1,"featured_media":920,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[53],"tags":[],"class_list":["post-834","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\/834","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=834"}],"version-history":[{"count":3,"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/posts\/834\/revisions"}],"predecessor-version":[{"id":921,"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/posts\/834\/revisions\/921"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/media\/920"}],"wp:attachment":[{"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/media?parent=834"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/categories?post=834"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/guires.uk\/newsroom\/wp-json\/wp\/v2\/tags?post=834"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}