{"id":6129,"date":"2022-05-27T09:09:09","date_gmt":"2022-05-27T07:09:09","guid":{"rendered":"https:\/\/www.rapharm.eu\/en\/?p=6129"},"modified":"2022-05-27T11:10:18","modified_gmt":"2022-05-27T09:10:18","slug":"eu-new-harmonized-standards-for-mdr-and-ivdr-regulation-have-been-published","status":"publish","type":"post","link":"https:\/\/www.rapharm.eu\/en\/eu-new-harmonized-standards-for-mdr-and-ivdr-regulation-have-been-published\/","title":{"rendered":"EU: New harmonized standards for MDR and IVDR regulation have been published"},"content":{"rendered":"<style type=\"text\/css\"><\/style>\n<p>In May 2022,\nCommission Implementing Decisions (EU) <a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2022\/757\/oj\">2022\/757<\/a> on new harmonized standards for MDR and <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=uriserv%3AOJ.L_.2022.135.01.0031.01.ENG&amp;toc=OJ%3AL%3A2022%3A135%3ATOC\">2022\/729<\/a> on new harmonized standards for IVDR were\npublished in the Official Journal of the European Union. New standards are the\nsecond addition to the first harmonized standards for <a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2021\/1182\/oj?locale=en\">MDR<\/a> and <a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2021\/1195\/oj?locale=en\">IVDR<\/a> published in July 2021.<\/p>\n\n\n\n<p>The harmonized\nstandard is a European standard developed by a recognized European standards\norganization: <a href=\"https:\/\/www.cencenelec.eu\/\">CEN<\/a>, <a href=\"https:\/\/www.cencenelec.eu\/\">CENELEC<\/a> or <a href=\"https:\/\/www.etsi.org\/\">ETSI<\/a> and published in\nthe Official Journal of the European Union. Manufacturers, other economic\noperators or notified bodies may use harmonized standards to demonstrate that\ndevices, services, or procedures comply with the requirements of MDR\/IVDR.<\/p>\n\n\n\n<p>Two new MDR\nstandards have been harmonized and entry of one harmonized standard updated<\/p>\n\n\n\n<p>Commission\nImplementing Decision (EU) 2022\/757 of 11 May 2022 amended Implementing\nDecision (EU) 2021\/1182\nconcerning harmonized standards for quality management systems, sterilisation\nand application of risk management to medical devices.<\/p>\n\n\n\n<p>The document adds\ntwo new harmonized standards for MDR in addition to the fourteen already published in the previous\nImplementing Decisions (EU) <a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2021\/1182\/oj?locale=en\">2021\/1182<\/a> and <a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2022\/6\/oj\">2022\/6<\/a>. Entry for harmonized standard for quality\nmanagement systems is updated.<\/p>\n\n\n\n<p>One new\nIVDR standard has been harmonized and entry of one harmonized standard updated<\/p>\n\n\n\n<p>Commission\nImplementing Decision (EU) 2022\/729 of 11 May 2022 amended Implementing\nDecision (EU) 2021\/1195 as regards harmonized standards for quality management\nsystems and for application of risk management to medical devices.<\/p>\n\n\n\n<p>The\ndocument adds one new harmonized standard for IVDR in addition to the nine already\npublished in the previous Implementing Decisions (EU) <a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2021\/1195\/oj?locale=en\">2021\/1195<\/a> and <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A32022D0015&amp;qid=1653552087264\">2022\/15<\/a>. Entry for harmonized standard for quality\nmanagement systems is updated.<\/p>\n\n\n\n<p>Harmonized\nstandard for quality management systems EN ISO 13485:2016 is updated with amendment\nA11:2021. It includes two new annexes ZA and ZB, which cover the relationship\nof this standard with:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>the\ngeneral obligations of the manufacturer in Article 10 of MDR and IVDR and<\/li><li>the\nquality management system requirements in the conformity assessment annexes\n(Annexes IX and XI of MDR and IVDR).<\/li><\/ul>\n\n\n\n<p>In\naddition, this Annexes include a description of the regulatory processes and activities\nundertaken by the notified body, competent authority and European Commission,\nwhich are outside of the scope of EN ISO 13485 and therefore not covered by the\nstandard.<\/p>\n\n\n\n<p><strong>Do you\nneed additional knowledge or assistance in meeting the requirements of\nMDR\/IVDR?<\/strong><\/p>\n\n\n\n<p>With the\nhelp of our <a href=\"https:\/\/www.rapharm.eu\/en\/actual-educations\/\">educations<\/a> and <a href=\"https:\/\/www.rapharm.eu\/en\/consulting-services\/\">consulting services<\/a>, we can help you meet the requirements of the\nMDR\/IVDR.<\/p>\n\n\n\n<p><strong>Resource:<\/strong><\/p>\n\n\n\n<p><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2022\/757\/oj\">COMMISSION IMPLEMENTING DECISION (EU)\n2022\/757, Official Journal of\nthe European Union, 11<sup>th<\/sup> May 2022<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=uriserv%3AOJ.L_.2022.135.01.0031.01.ENG&amp;toc=OJ%3AL%3A2022%3A135%3ATOC\">COMMISSION IMPLEMENTING DECISION (EU)\n2022\/729, Official Journal of the European Union, 11<sup>th<\/sup> May 2022<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In May 2022, Commission Implementing Decisions (EU) 2022\/757 on new harmonized standards for MDR and 2022\/729 on new harmonized standards for IVDR were published in the Official Journal of the European Union. New standards are the second addition to the first harmonized standards for MDR and IVDR published in July 2021. The harmonized standard is&#8230;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[45,30],"tags":[],"class_list":["post-6129","post","type-post","status-publish","format-standard","hentry","category-novice-en","category-uncategorized"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EU: New harmonized standards for MDR and IVDR regulation have been published - raPHARM<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.rapharm.eu\/eu-objavljeni-so-novi-harmonizirani-standardi-za-mdr-in-ivdr-uredbo-2\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU: New harmonized standards for MDR and IVDR regulation have been published - raPHARM\" \/>\n<meta property=\"og:description\" content=\"In May 2022, Commission Implementing Decisions (EU) 2022\/757 on new harmonized standards for MDR and 2022\/729 on new harmonized standards for IVDR were published in the Official Journal of the European Union. New standards are the second addition to the first harmonized standards for MDR and IVDR published in July 2021. The harmonized standard is...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.rapharm.eu\/eu-objavljeni-so-novi-harmonizirani-standardi-za-mdr-in-ivdr-uredbo-2\/\" \/>\n<meta property=\"og:site_name\" content=\"raPHARM\" \/>\n<meta property=\"article:published_time\" content=\"2022-05-27T07:09:09+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-05-27T09:10:18+00:00\" \/>\n<meta name=\"author\" content=\"rapharm\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"rapharm\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.rapharm.eu\/eu-objavljeni-so-novi-harmonizirani-standardi-za-mdr-in-ivdr-uredbo-2\/\",\"url\":\"https:\/\/www.rapharm.eu\/eu-objavljeni-so-novi-harmonizirani-standardi-za-mdr-in-ivdr-uredbo-2\/\",\"name\":\"EU: New harmonized standards for MDR and IVDR regulation have been published - raPHARM\",\"isPartOf\":{\"@id\":\"https:\/\/www.rapharm.eu\/#website\"},\"datePublished\":\"2022-05-27T07:09:09+00:00\",\"dateModified\":\"2022-05-27T09:10:18+00:00\",\"author\":{\"@id\":\"https:\/\/www.rapharm.eu\/#\/schema\/person\/ba2051c1c51d2328945ac838b3f1d7e1\"},\"breadcrumb\":{\"@id\":\"https:\/\/www.rapharm.eu\/eu-objavljeni-so-novi-harmonizirani-standardi-za-mdr-in-ivdr-uredbo-2\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.rapharm.eu\/eu-objavljeni-so-novi-harmonizirani-standardi-za-mdr-in-ivdr-uredbo-2\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.rapharm.eu\/eu-objavljeni-so-novi-harmonizirani-standardi-za-mdr-in-ivdr-uredbo-2\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.rapharm.eu\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"EU: New harmonized standards for MDR and IVDR regulation have been published\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.rapharm.eu\/#website\",\"url\":\"https:\/\/www.rapharm.eu\/\",\"name\":\"raPHARM\",\"description\":\"Just another WordPress site\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.rapharm.eu\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.rapharm.eu\/#\/schema\/person\/ba2051c1c51d2328945ac838b3f1d7e1\",\"name\":\"rapharm\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.rapharm.eu\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/9ea8e299db6979b3c68307fd37c34f245020d4996bcf2ccdeec4bce3350fcc24?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/9ea8e299db6979b3c68307fd37c34f245020d4996bcf2ccdeec4bce3350fcc24?s=96&d=mm&r=g\",\"caption\":\"rapharm\"},\"url\":\"https:\/\/www.rapharm.eu\/en\/author\/rapharm\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"EU: New harmonized standards for MDR and IVDR regulation have been published - raPHARM","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.rapharm.eu\/eu-objavljeni-so-novi-harmonizirani-standardi-za-mdr-in-ivdr-uredbo-2\/","og_locale":"en_US","og_type":"article","og_title":"EU: New harmonized standards for MDR and IVDR regulation have been published - raPHARM","og_description":"In May 2022, Commission Implementing Decisions (EU) 2022\/757 on new harmonized standards for MDR and 2022\/729 on new harmonized standards for IVDR were published in the Official Journal of the European Union. 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