{"id":14556,"date":"2020-05-27T11:43:18","date_gmt":"2020-05-27T09:43:18","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=14556"},"modified":"2023-01-24T14:59:10","modified_gmt":"2023-01-24T13:59:10","slug":"europe-new-guidelines-published-by-mdcg","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/en\/2020\/05\/27\/europe-new-guidelines-published-by-mdcg\/","title":{"rendered":"EUROPE: new guidelines published by MDCG"},"content":{"rendered":"\n<p>The Medical Device Coordination Group (<strong>MDCG<\/strong>) has recently published several\ninteresting <strong>guidelines <\/strong>for the medical\nand in vitro diagnostic medical devices fields. <\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/05\/ue-linee-guida-mdcg-1-1024x536.png\" alt=\"Europe new guidelines published by MDCG\" class=\"wp-image-14540\"\/><figcaption>New guidelines published by MDCG<\/figcaption><\/figure>\n\n\n\n<p>The <strong>MDCG\n2020-5 \u201cClinical Evaluation \u2013 Equivalence. A guide for manufacturers and\nnotified bodies\u201d <\/strong>guideline aims to underline the differences between the\nMDR and the guide MEDDEV 2.7 \/ 1 rev.4 with regard to criteria that have to be\nfulfilled for the demonstration of <strong>equivalence.\n<\/strong>The differences concern <strong>technical,\nbiological and clinical characteristics. <\/strong>The equivalence has to be\ndemonstrated according to the <strong>MDR <\/strong>requirements\nand the relevant documentation has to be included within the <strong>clinical evaluation <\/strong>report. <\/p>\n\n\n\n<p>The <strong>MDCG 2020-6 \u201cRegulation (EU) 2017\/745: Clinical\nevidence needed for medical devices previously CE marked under Directives\n93\/42\/EEC or 90\/385\/EEC. A guide for manufacturers and\nnotified bodies\u201d<\/strong> guideline provides information on\nthe necessary clinical data and evidences sufficient to demonstrate the\nconformity with the relevant General Safety and Performance Requirements (<strong>GSPR<\/strong>) (article 61 MDR) for the legacy\ndevices, carrying the 93\/42\/CEE (MDD) or 90\/385\/CEE (AIMDD) CE mark. The\ndocument includes information for Manufacturers and Notified Bodies to carry\nout the conformity assessment procedure and the clinical investigations\naccording to <strong>article 61 of the MDR. <\/strong>With\nregard to the 93\/42\/CEE and 90\/385\/CEE Directives, the MDR provides further\ndetails and indicates a series of important factors for the clinical evaluation\nprocess. <\/p>\n\n\n\n<p>In the <strong>MDCG 2020-7 \u201cPost-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies\u201d <\/strong>guideline, the attention is placed on the development of a <strong>post-marketing clinical follow-up <\/strong>plan <strong>(PMCF) <\/strong>required by the MDR. <br>The <strong>PMCF plan <\/strong>in part of the post-market surveillance plan. The Manufacturer, after making the analysis, has to document the results in a PMCF evaluation report. This report has to be included in the Clinical Evaluation Report and in the Technical Documentation and it can be evaluated by the Notified Body. <\/p>\n\n\n\n<p>The <strong>MDCG 2020-8 \u201cPost-market clinical follow-up (PMCF) Evaluation\nReport Template. <\/strong><strong>A guide for manufacturers and\nnotified bodies\u201d <\/strong>document\nadds the template of the evaluation report of the PMCF plan to the previous guideline.\nIn order to update the Clinical Evaluation and the Post-Market Surveillance\nPlan, the conclusions of this report have to be taken into account. <\/p>\n\n\n\n<p>The <strong>MDCG 2020-9 \u201cRegulatory Requirements for Ventilators and Related Accessories\u201d <\/strong>guideline shows several normative options to support production and placing on the market of ventilators in the context of <strong>COVID-19 <\/strong>pandemia. <br>For example, according to the <strong>derogation procedure <\/strong>contained in the document \u201cGuidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the Covid-19 context\u201d, the Competent Authority of the Member State, in the interests of public health, authorizes the placing on the market of the medical devices in his territory and he can also arrange their purchase. <\/p>\n\n\n\n<p><strong>Thema offers <a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\">strategic-regulatory consultancy<\/a> and <a href=\"https:\/\/www.thema-med.com\/en\/services\/ce-certification-support\/\">CE certification support<\/a> of medical devices and IVD.<\/strong><br><strong>In order to know what we can do for you, contact us!<\/strong> <a href=\"mailto:sales@thema-group.it\"><strong>sales@thema-group.it<\/strong><\/a><\/p>\n\n\n\n<p><em>Sources: <\/em> <\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/40903\">https:\/\/ec.europa.eu\/docsroom\/documents\/40903<\/a>  <a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/40904\">https:\/\/ec.europa.eu\/docsroom\/documents\/40904<\/a>  <a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/40905\">https:\/\/ec.europa.eu\/docsroom\/documents\/40905<\/a>  <a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/40906\">https:\/\/ec.europa.eu\/docsroom\/documents\/40906<\/a>  <a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/40941\">https:\/\/ec.europa.eu\/docsroom\/documents\/40941<\/a>  <a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/40607\">https:\/\/ec.europa.eu\/docsroom\/documents\/40607<\/a> <\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Medical Device Coordination Group (MDCG) has recently published several interesting guidelines for the medical and in vitro diagnostic medical devices  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-14556","post","type-post","status-publish","format-standard","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EUROPE: new guidelines published by MDCG<\/title>\n<meta name=\"description\" content=\"MDCG has recently published several interesting guidelines for the medical and in vitro diagnostic medical devices fields.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link 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