{"id":23778,"date":"2022-09-20T16:22:31","date_gmt":"2022-09-20T14:22:31","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=23778"},"modified":"2022-09-20T16:26:54","modified_gmt":"2022-09-20T14:26:54","slug":"europe-mdcg-2022-14-immediate-actions-planned-to-facilitate-transition-to-mdr-ivdr","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2022\/09\/20\/europe-mdcg-2022-14-immediate-actions-planned-to-facilitate-transition-to-mdr-ivdr\/","title":{"rendered":"EUROPE: MDCG 2022-14 | Immediate actions planned to facilitate transition to MDR\/IVDR"},"content":{"rendered":"<h2>To this date, it is still difficult for Manufacturers to embark on an MDR or IVDR certification pathway in a way that is <strong>clear, accessible<\/strong>, and that ensures <strong>continuity<\/strong> in device commercialization. For this reason, the MDCG Guideline 2022-14 <a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2022-14-transition-mdr-and-ivdr-notified-body-capacity-and-availability-medical-devices-and-2022-08-26_en\"><em>Transition to the MDR and IVDR Notified body capacity and availability of medical devices and IVDs<\/em><\/a>, issued last August, lists immediate actions to be taken by Notified Bodies, Manufacturers, and Economic Operators in general.<\/h2>\n<p>Among the recommendations reported by the Medical Device Coordination Group to <strong>Notified Bodies<\/strong>, some are particularly significant:<\/p>\n<ul>\n<li>using Hybrid Audits;<\/li>\n<li>promoting the development of Notified Bodies through training, mentoring and internship activities for their staff. In addition, Notified Bodies should streamline internal administrative procedures;<\/li>\n<li>speeding up the process of assessment, designation and notification of Notified Bodies;<\/li>\n<li>adding Notified Body designation codes in a timely manner;<\/li>\n<li>allowing flexibility to Economic Operators, Notified Bodies and Competent Authorities on how to demonstrate compliance with legal requirements and within reasonable timeframes.<\/li>\n<\/ul>\n<p>There are also some requirements for the Notified Bodies, including making <strong>fees<\/strong> public and easily comparable and providing resources to assist small and medium-sized companies and organizations that are to enter the medical market for the first time, including providing information through common guidelines and content sharing.<\/p>\n<p>In addition, the guideline urges Manufacturers <strong>not to wait<\/strong> until the end of the Period of Grace to begin the certification process and recommends <strong>structured meetings and dialogues<\/strong> with the Notified Body before and during the conformity assessment process.<\/p>\n<p>Through the MDCG Guideline 2022-14, the European Commission has taken <strong>an important first step<\/strong> in order to resolve significant issues that are still existing and which could delay market access for In Vitro Medical Devices and Diagnostics.<\/p>\n<p>&gt;&gt;&gt; Through our <a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\">strategic-regulatory consulting services<\/a>, <a href=\"https:\/\/www.thema-med.com\/en\/services\/ce-certification-support\/\">CE certification support<\/a> and if necessary, of <a href=\"https:\/\/www.thema-med.com\/en\/services\/local-representative-and-license-holder\/european-authorised-representative-service\/\">European Authorized Representative<\/a>, Thema can support you in complying with the requirements of the Medical Device Regulation MDR (EU) 2017\/745 and IVDR (EU) 2017\/746 In Vitro Diagnostic Medical Devices.<\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/en\/contact-us-2\/\">Contact us<\/a> for more info!<\/p>\n<p>Source: <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2022-08\/mdcg_2022-14_en.pdf\">https:\/\/health.ec.europa.eu\/system\/files\/2022-08\/mdcg_2022-14_en.pdf<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>To this date, it is still difficult for Manufacturers to embark on an MDR or IVDR certification pathway in a way  [&#8230;]<\/p>\n","protected":false},"author":114,"featured_media":23772,"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-23778","post","type-post","status-publish","format-standard","has-post-thumbnail","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: MDCG 2022-14 | Immediate actions planned<\/title>\n<meta name=\"description\" content=\"To this date, it is still difficult for Manufacturers to embark on an MDR or IVDR certification pathway. 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