{"id":19964,"date":"2022-01-19T15:42:19","date_gmt":"2022-01-19T14:42:19","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=19964"},"modified":"2022-01-19T15:42:19","modified_gmt":"2022-01-19T14:42:19","slug":"eu-new-standards-harmonised-for-mdr-ivdr-regulations","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2022\/01\/19\/eu-new-standards-harmonised-for-mdr-ivdr-regulations\/","title":{"rendered":"EU: new standards harmonised for MDR and IVDR regulations"},"content":{"rendered":"\n<p>In the first week of January 2022, <strong>Commission Implementing Decision (EU) 2022\/6<\/strong> concerning<strong> new harmonised standards MDR (EU) 2017\/745<\/strong>, and <strong>Commission Implementing Decision (EU) 2022\/15<\/strong> on new <strong>harmonised standards IVDR (EU) 2017\/746<\/strong> have been published on the Official Journal of the European Union.<\/p>\n\n\n\n<p>These standards are in addition to the <a href=\"https:\/\/www.thema-med.com\/en\/eu-first-mdr-ivdr-harmonised-standards-published\/\">first standards harmonised MDR and IVDR<\/a> published in July 2021.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/01\/ue-mdr-ivdr-harmonised-standards-1024x536.jpg\" alt=\"europe new standards harmonised for MDR and IVDR regulations\" class=\"wp-image-19902\"\/><figcaption>New standards harmonised for MDR and IVDR regulations<\/figcaption><\/figure>\n\n\n\n<p>Please remember that harmonised standards are <strong>European standards<\/strong> drawn up by a European Standardisation Organisations (ESO), such as CEN, CENELEC, ETSI, and they are valid for all EU countries.<\/p>\n\n\n\n<p>The <strong>goal of harmonised standards<\/strong> is to\nhelp Third parties in\ninterpreting security requirements to <strong>obtain<\/strong> the <strong>conformity of the\nproduct<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>9 new standards MDR harmonised <\/strong><\/h2>\n\n\n\n<p>The EU Commission Implementing Decision (EU) 2022\/6 of 4<sup>th<\/sup> January 2022 has modified the Implementing Decision (EU) 2021\/1182 regarding harmonised standards for biological evaluation of medical devices, sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer, processing of health care products and home light therapy equipment.<\/p>\n\n\n\n<p>The paper provides<strong> 9 new standards harmonised MDR<\/strong> in addition to the five already published in the previous Implementing Decision (EU) 2021\/1182, for a total amount of 14 standards harmonised MDR issued:<\/p>\n\n\n\n<p><strong>1.EN ISO 10993-9:2021<\/strong><br>Biological evaluation of medical devices &#8211; Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019).<\/p>\n\n\n\n<p><strong>2.EN ISO 10993-12:2021 <\/strong><br>Biological evaluation of medical devices &#8211; Part 12: Sample preparation and reference materials (ISO 10993-12:2021).<br><\/p>\n\n\n\n<p><strong>3.EN ISO 11737-1:2018 <\/strong><br>Sterilization of health care products &#8211; Microbiological methods &#8211; Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018).<br>EN ISO 11737-1:2018\/A1:2021 <\/p>\n\n\n\n<p><strong>4.EN ISO 13408-6:2021 <\/strong><br>Aseptic processing of health care products &#8211; Part 6: Isolator systems (ISO 13408-6:2021).<\/p>\n\n\n\n<p><strong>5.EN ISO 13485:2016 <\/strong><br>Medical devices &#8211; Quality management systems &#8211; Requirements for regulatory purposes (ISO 13485:2016).<br>EN ISO 13485:2016\/A11:2021<\/p>\n\n\n\n<p><strong>6.EN ISO 14160:2021<\/strong><br>Sterilization of health care products &#8211; Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives &#8211; Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020).<\/p>\n\n\n\n<p><strong>7.EN ISO 15223-1:2021<\/strong><br>Medical devices &#8211; Symbols to be used with information to be supplied by the manufacturer &#8211; Part 1: General requirements (ISO 15223-1:2021).<\/p>\n\n\n\n<p><strong>8.EN ISO 17664-1:2021<\/strong><br>Processing of health care products &#8211; Information to be provided by the medical device manufacturer for the processing of medical devices &#8211; Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021).<\/p>\n\n\n\n<p><strong>9.EN IEC 60601-2-83:2020<\/strong> <br>Medical electrical equipment &#8211; Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment.<br>EN IEC 60601-2-83:2020\/A11:2021\u00bb.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>5 new standards harmonised IVDR <\/strong><\/h2>\n\n\n\n<p>On 6<sup>th<\/sup> January 2022, it was published the Commission <strong>Implementing Decision (EU) 2022\/15<\/strong> that edits the Implementing Decision (EU) 2021\/1195 regarding harmonised standards for sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer and requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples.  <\/p>\n\n\n\n<p>The\npaper presents the following <strong>five new standards harmonised IVDR<\/strong> in\naddition to the other four harmonised standards published in July 2021:<\/p>\n\n\n\n<p><strong>1.EN ISO 11737-1:2018 <\/strong><br>Sterilization of health care products \u2013 Microbiological methods \u2013 Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018).<br>EN ISO 11737-1:2018\/A1:2021<\/p>\n\n\n\n<p><strong>2.EN ISO 13408-6:2021 <\/strong><br>Aseptic processing of health care products \u2013 Part 6: Isolator systems (ISO 13408-6:2021).<\/p>\n\n\n\n<p><strong>3.EN ISO 13485:2016 <\/strong><br>Medical devices \u2013 Quality management systems \u2013 Requirements for regulatory purposes (ISO 13485:2016).<br>EN ISO 13485:2016\/A11:2021<\/p>\n\n\n\n<p><strong>4.EN ISO 15223-1:2021 <\/strong><br>Medical devices \u2013 Symbols to be used with information to be supplied by the manufacturer \u2013 Part 1: General requirements (ISO 15223-1:2021).<\/p>\n\n\n\n<p><strong>5.EN ISO 17511:2021 <\/strong><br>In vitro diagnostic medical devices \u2013 Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)\u2019.<\/p>\n\n\n\n<p>As of today, a total of 9 standards harmonised IVDR were therefore issued.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Do you need any help adjusting\nto MDR and IVDR Regulations?<\/strong><\/h2>\n\n\n\n<p>Through our <strong><a rel=\"noreferrer noopener\" aria-label=\"strategic-regulatory consultancy (si apre in una nuova scheda)\" href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\" target=\"_blank\">strategic-regulatory consultancy<\/a><\/strong> services we can fully support you in the adjustment process to MDR (UE) 2017\/745 and to IVDR (UE) 2017\/746.<br><strong><a href=\"mailto:sales@thema-med.com\">Contact us for information!<\/a><\/strong><\/p>\n\n\n\n<p><em>Source:<\/em><\/p>\n\n\n\n<p><a rel=\"noreferrer noopener\" aria-label=\"COMMISSION IMPLEMENTING DECISION (EU) 2022\/6, Official Journal of the European Union, 4 January 2022 (si apre in una nuova scheda)\" href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32022D0006&amp;from=EN\" target=\"_blank\">COMMISSION IMPLEMENTING DECISION (EU) 2022\/6, Official Journal of the European Union, 4 January 2022<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32022D0015&amp;from=EN\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"COMMISSION IMPLEMENTING DECISION (EU) 2022\/15, Official Journal of the European Union, 6 January 2022 (si apre in una nuova scheda)\">COMMISSION IMPLEMENTING DECISION (EU) 2022\/15, Official Journal of the European Union, 6 January 2022<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>In the first week of January 2022, Commission Implementing Decision (EU) 2022\/6 concerning new harmonised standards MDR (EU) 2017\/745, and Commission  [&#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":[1],"tags":[],"class_list":["post-19964","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EU:new standards harmonised for MDR and IVDR regulations<\/title>\n<meta name=\"description\" content=\"In the first week of January 2022, the implementing decisions on the new standards harmonised for MDR and IVDR were published in the EU Official Journal\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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