{"id":5867,"date":"2022-03-24T09:00:35","date_gmt":"2022-03-24T08:00:35","guid":{"rendered":"https:\/\/www.rapharm.eu\/en\/2022\/03\/08\/eu-objavljeni-so-novi-harmonizirani-standardi-za-mdr-in-ivdr-uredbo\/"},"modified":"2022-05-25T14:30:02","modified_gmt":"2022-05-25T12:30:02","slug":"eu-objavljeni-so-novi-harmonizirani-standardi-za-mdr-in-ivdr-uredbo","status":"publish","type":"post","link":"https:\/\/www.rapharm.eu\/en\/eu-objavljeni-so-novi-harmonizirani-standardi-za-mdr-in-ivdr-uredbo\/","title":{"rendered":"EU: New harmonized standards for MDR and IVDR regulation have been published"},"content":{"rendered":"<style type=\"text\/css\"><\/style>\n<p>In the first week\nof January 2022, Commission Implementing Decisions (EU) <a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2022\/6\/oj?locale=en\">2022\/6<\/a> on new harmonized standards for MDR and <a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2022\/15\/oj?locale=en\">2022\/15<\/a> on new harmonized standards for IVDR were\npublished in the Official Journal of the European Union. The standards are in\naddition 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>Nine new MDR\nstandards have been harmonized<\/p>\n\n\n\n<p>Commission\nImplementing Decision (EU) 2022\/6 of 4 January 2022 amended Implementing\nDecision (EU) 2021\/1182 concerning harmonized standards for the biological evaluation\nof medical devices, sterilization of health care products, aseptic processing\nof health care products, quality management systems, symbols to be used with\ninformation to be supplied by the manufacturer, processing of health care\nproducts and home light therapy equipment.<\/p>\n\n\n\n<p>The document adds\nnine new harmonized standards for MDR in addition to the five already published\nin the previous Implementing Decision (EU) 2021\/1182.<\/p>\n\n\n\n<p>Five new IVDR\nstandards have been harmonized<\/p>\n\n\n\n<p>Commission\nImplementing Decision (EU) 2022\/15 of 6 January 2022 amended Implementing\nDecision (EU) 2021\/1195 as regards harmonised standards for sterilisation of\nhealth care products, aseptic processing of health care products, quality\nmanagement systems, symbols to be used with information to be supplied by the\nmanufacturer and requirements for establishing metrological traceability of\nvalues assigned to calibrators, trueness control materials and human samples<\/p>\n\n\n\n<p>The document adds\nfive new harmonized standards for IVDR in addition to the four already\npublished in the previous Implementing Decision (EU) 2021\/1195.<\/p>\n\n\n\n<p>Two new\nharmonized standards must be mentioned, EN ISO 13485: 2016 and EN ISO 15223-1:\n2021, which can be used by all economic operators, including distributors and\nimporters, to meet the requirements of MDR\/IVDR.<\/p>\n\n\n\n<p><strong>EN ISO\n13485:2016<\/strong><\/p>\n\n\n\n<p>Medical devices &#8211;\nQuality management systems &#8211; Requirements for regulatory purposes (ISO\n13485:2016)<\/p>\n\n\n\n<p>EN ISO\n13485:2016\/A11:2021<\/p>\n\n\n\n<p><strong>EN ISO\n15223-1:2021<\/strong><\/p>\n\n\n\n<p>Medical devices &#8211;\nSymbols to be used with information to be supplied by the manufacturer &#8211; Part\n1: General requirements (ISO 15223-1:2021)<\/p>\n\n\n\n<p>We have already\nincluded individual contents of the mentioned standards in our trainings in the\nfield of storage, distribution and import of devices and inspection of devices.\nWe are also preparing a new training, which will present the standard EN ISO\n15223-1:2021 and some new symbols and their use, as well as the new standard EN\nISO 20417:2021, information provided by the manufacturer, which is not yet\nharmonized, but in combination with EN ISO 15223-1: 2021 is of great help in\npreparing the information provided by the manufacturer on the label, packaging,\ninstructions for use as well as in the verification of this information by the\ndistributor and importer.<\/p>\n\n\n\n<p><strong>Do you need\nadditional knowledge or assistance in meeting the requirements of MDR\/IVDR?<\/strong><\/p>\n\n\n\n<p>With the help 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>,\nwe can help you meet the requirements of the MDR\/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\/6\/oj?locale=en\">COMMISSION IMPLEMENTING DECISION (EU) 2022\/6, Official Journal of the European Union, 4<sup>th<\/sup> January 2022<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2022\/15\/oj?locale=en\">COMMISSION IMPLEMENTING DECISION (EU) 2022\/15, Official Journal of the\nEuropean Union, 6<sup>th<\/sup> January 2022<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In the first week of January 2022, Commission Implementing Decisions (EU) 2022\/6 on new harmonized standards for MDR and 2022\/15 on new harmonized standards for IVDR were published in the Official Journal of the European Union. The standards are in addition to the first harmonized standards for MDR and IVDR published in July 2021. The&#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],"tags":[],"class_list":["post-5867","post","type-post","status-publish","format-standard","hentry","category-novice-en"],"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\/en\/eu-objavljeni-so-novi-harmonizirani-standardi-za-mdr-in-ivdr-uredbo\/\" \/>\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 the first week of January 2022, Commission Implementing Decisions (EU) 2022\/6 on new harmonized standards for MDR and 2022\/15 on new harmonized standards for IVDR were published in the Official Journal of the European Union. The standards are in addition to the first harmonized standards for MDR and IVDR published in July 2021. 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