{"id":5958,"date":"2022-09-30T15:34:00","date_gmt":"2022-09-30T13:34:00","guid":{"rendered":"https:\/\/m2apartners.cz\/mdr-for-the-second-time-risk-management-system\/"},"modified":"2025-03-27T17:05:22","modified_gmt":"2025-03-27T16:05:22","slug":"mdr-for-the-second-time-risk-management-system","status":"publish","type":"post","link":"https:\/\/m2apartners.cz\/en\/mdr-for-the-second-time-risk-management-system\/","title":{"rendered":"MDR for the second time &#8211; risk management system"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Our next article on MDR, this time in relation to the risk management system that every manufacturer is obliged to have under the new regulation. Read more here: <a href=\"https:\/\/www.tribune.cz\/clanek\/44589-mdr-podruhe-system-pro-rizeni-rizik\" target=\"_blank\" rel=\"noreferrer noopener\">https:\/\/www.tribune.cz\/clanek\/44589-mdr-podruhe-system-pro-rizeni-rizik<\/a> <\/p>\n","protected":false},"excerpt":{"rendered":"<p>Our next article on MDR, this time in relation to the risk management system that every manufacturer is obliged to have under the new regulation. Read more here: https:\/\/www.tribune.cz\/clanek\/44589-mdr-podruhe-system-pro-rizeni-rizik<\/p>\n","protected":false},"author":1,"featured_media":5523,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"categories":[320,357],"tags":[358,360,514,511],"class_list":["post-5958","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles","category-medical-devices","tag-eu-legislation","tag-mdr-en","tag-medicines","tag-pharmaceutical-industry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>MDR for the second time - risk management system - m2apartners.cz<\/title>\n<meta name=\"description\" content=\"This article is the second in a series dedicated to the new Regulation (EU) 2017\/745 of the European Parliament and of the Council on medical devices (the &quot;MDR&quot;). In the introductory article, which appeared in MT 7\/2019, we looked generally at the obligations arising from the MDR and, in particular, the points at which it will be necessary to comply with the rules set out therein.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/m2apartners.cz\/en\/mdr-for-the-second-time-risk-management-system\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MDR for the second time - risk management system - m2apartners.cz\" \/>\n<meta property=\"og:description\" content=\"This article is the second in a series dedicated to the new Regulation (EU) 2017\/745 of the European Parliament and of the Council on medical devices (the &quot;MDR&quot;). In the introductory article, which appeared in MT 7\/2019, we looked generally at the obligations arising from the MDR and, in particular, the points at which it will be necessary to comply with the rules set out therein.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/m2apartners.cz\/en\/mdr-for-the-second-time-risk-management-system\/\" \/>\n<meta property=\"og:site_name\" content=\"m2apartners.cz\" \/>\n<meta property=\"article:published_time\" content=\"2022-09-30T13:34:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-03-27T16:05:22+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/m2apartners.cz\/wp-content\/uploads\/2022\/09\/2.png\" \/>\n\t<meta property=\"og:image:width\" content=\"940\" \/>\n\t<meta property=\"og:image:height\" content=\"788\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"admin3645\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"admin3645\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/m2apartners.cz\\\/en\\\/mdr-for-the-second-time-risk-management-system\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/m2apartners.cz\\\/en\\\/mdr-for-the-second-time-risk-management-system\\\/\"},\"author\":{\"name\":\"admin3645\",\"@id\":\"https:\\\/\\\/m2apartners.cz\\\/en\\\/#\\\/schema\\\/person\\\/2737d6d592b954976f2a3fdcb4e8248e\"},\"headline\":\"MDR for the second time &#8211; risk management system\",\"datePublished\":\"2022-09-30T13:34:00+00:00\",\"dateModified\":\"2025-03-27T16:05:22+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/m2apartners.cz\\\/en\\\/mdr-for-the-second-time-risk-management-system\\\/\"},\"wordCount\":43,\"publisher\":{\"@id\":\"https:\\\/\\\/m2apartners.cz\\\/en\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/m2apartners.cz\\\/en\\\/mdr-for-the-second-time-risk-management-system\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/m2apartners.cz\\\/wp-content\\\/uploads\\\/2022\\\/09\\\/2.png\",\"keywords\":[\"EU legislation\",\"MDR\",\"Medicines\",\"pharmaceutical industry\"],\"articleSection\":[\"Articles\",\"Medical devices\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/m2apartners.cz\\\/en\\\/mdr-for-the-second-time-risk-management-system\\\/\",\"url\":\"https:\\\/\\\/m2apartners.cz\\\/en\\\/mdr-for-the-second-time-risk-management-system\\\/\",\"name\":\"MDR for the second time - risk management system - m2apartners.cz\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/m2apartners.cz\\\/en\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/m2apartners.cz\\\/en\\\/mdr-for-the-second-time-risk-management-system\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/m2apartners.cz\\\/en\\\/mdr-for-the-second-time-risk-management-system\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/m2apartners.cz\\\/wp-content\\\/uploads\\\/2022\\\/09\\\/2.png\",\"datePublished\":\"2022-09-30T13:34:00+00:00\",\"dateModified\":\"2025-03-27T16:05:22+00:00\",\"description\":\"This article is the second in a series dedicated to the new Regulation (EU) 2017\\\/745 of the European Parliament and of the Council on medical devices (the \\\"MDR\\\"). In the introductory article, which appeared in MT 7\\\/2019, we looked generally at the obligations arising from the MDR and, in particular, the points at which it will be necessary to comply with the rules set out therein.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/m2apartners.cz\\\/en\\\/mdr-for-the-second-time-risk-management-system\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/m2apartners.cz\\\/en\\\/mdr-for-the-second-time-risk-management-system\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/m2apartners.cz\\\/en\\\/mdr-for-the-second-time-risk-management-system\\\/#primaryimage\",\"url\":\"https:\\\/\\\/m2apartners.cz\\\/wp-content\\\/uploads\\\/2022\\\/09\\\/2.png\",\"contentUrl\":\"https:\\\/\\\/m2apartners.cz\\\/wp-content\\\/uploads\\\/2022\\\/09\\\/2.png\",\"width\":940,\"height\":788,\"caption\":\"Syst\u00e9m pro \u0159\u00edzen\u00ed rizik\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/m2apartners.cz\\\/en\\\/mdr-for-the-second-time-risk-management-system\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/m2apartners.cz\\\/en\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"MDR for the second time - risk management system\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/m2apartners.cz\\\/en\\\/#website\",\"url\":\"https:\\\/\\\/m2apartners.cz\\\/en\\\/\",\"name\":\"m2apartners.cz\",\"description\":\"We focus on providing legal services to clients in the pharmaceutical and medical device industries, in corporate matters, in connection with the setting up of internal processes, in matters of zoning and construction law proceedings, in general practice, especially general contract, real estate, family and employment law.\",\"publisher\":{\"@id\":\"https:\\\/\\\/m2apartners.cz\\\/en\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/m2apartners.cz\\\/en\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/m2apartners.cz\\\/en\\\/#organization\",\"name\":\"M2A Partners\",\"url\":\"https:\\\/\\\/m2apartners.cz\\\/en\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/m2apartners.cz\\\/en\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/m2apartners.cz\\\/wp-content\\\/uploads\\\/2025\\\/03\\\/cropped-cropped-FAV_512x512.png\",\"contentUrl\":\"https:\\\/\\\/m2apartners.cz\\\/wp-content\\\/uploads\\\/2025\\\/03\\\/cropped-cropped-FAV_512x512.png\",\"width\":512,\"height\":512,\"caption\":\"M2A Partners\"},\"image\":{\"@id\":\"https:\\\/\\\/m2apartners.cz\\\/en\\\/#\\\/schema\\\/logo\\\/image\\\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/m2apartners.cz\\\/en\\\/#\\\/schema\\\/person\\\/2737d6d592b954976f2a3fdcb4e8248e\",\"name\":\"admin3645\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/baf40bb2dd82590384e4496ea9a16e5723a6284ec7fb445ad629f19905b6c337?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/baf40bb2dd82590384e4496ea9a16e5723a6284ec7fb445ad629f19905b6c337?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/baf40bb2dd82590384e4496ea9a16e5723a6284ec7fb445ad629f19905b6c337?s=96&d=mm&r=g\",\"caption\":\"admin3645\"},\"sameAs\":[\"https:\\\/\\\/m2apartners.cz\"]}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"MDR for the second time - risk management system - m2apartners.cz","description":"This article is the second in a series dedicated to the new Regulation (EU) 2017\/745 of the European Parliament and of the Council on medical devices (the \"MDR\"). In the introductory article, which appeared in MT 7\/2019, we looked generally at the obligations arising from the MDR and, in particular, the points at which it will be necessary to comply with the rules set out therein.","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:\/\/m2apartners.cz\/en\/mdr-for-the-second-time-risk-management-system\/","og_locale":"en_US","og_type":"article","og_title":"MDR for the second time - risk management system - m2apartners.cz","og_description":"This article is the second in a series dedicated to the new Regulation (EU) 2017\/745 of the European Parliament and of the Council on medical devices (the \"MDR\"). In the introductory article, which appeared in MT 7\/2019, we looked generally at the obligations arising from the MDR and, in particular, the points at which it will be necessary to comply with the rules set out therein.","og_url":"https:\/\/m2apartners.cz\/en\/mdr-for-the-second-time-risk-management-system\/","og_site_name":"m2apartners.cz","article_published_time":"2022-09-30T13:34:00+00:00","article_modified_time":"2025-03-27T16:05:22+00:00","og_image":[{"width":940,"height":788,"url":"https:\/\/m2apartners.cz\/wp-content\/uploads\/2022\/09\/2.png","type":"image\/png"}],"author":"admin3645","twitter_card":"summary_large_image","twitter_misc":{"Written by":"admin3645"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/m2apartners.cz\/en\/mdr-for-the-second-time-risk-management-system\/#article","isPartOf":{"@id":"https:\/\/m2apartners.cz\/en\/mdr-for-the-second-time-risk-management-system\/"},"author":{"name":"admin3645","@id":"https:\/\/m2apartners.cz\/en\/#\/schema\/person\/2737d6d592b954976f2a3fdcb4e8248e"},"headline":"MDR for the second time &#8211; risk management system","datePublished":"2022-09-30T13:34:00+00:00","dateModified":"2025-03-27T16:05:22+00:00","mainEntityOfPage":{"@id":"https:\/\/m2apartners.cz\/en\/mdr-for-the-second-time-risk-management-system\/"},"wordCount":43,"publisher":{"@id":"https:\/\/m2apartners.cz\/en\/#organization"},"image":{"@id":"https:\/\/m2apartners.cz\/en\/mdr-for-the-second-time-risk-management-system\/#primaryimage"},"thumbnailUrl":"https:\/\/m2apartners.cz\/wp-content\/uploads\/2022\/09\/2.png","keywords":["EU legislation","MDR","Medicines","pharmaceutical industry"],"articleSection":["Articles","Medical devices"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/m2apartners.cz\/en\/mdr-for-the-second-time-risk-management-system\/","url":"https:\/\/m2apartners.cz\/en\/mdr-for-the-second-time-risk-management-system\/","name":"MDR for the second time - risk management system - m2apartners.cz","isPartOf":{"@id":"https:\/\/m2apartners.cz\/en\/#website"},"primaryImageOfPage":{"@id":"https:\/\/m2apartners.cz\/en\/mdr-for-the-second-time-risk-management-system\/#primaryimage"},"image":{"@id":"https:\/\/m2apartners.cz\/en\/mdr-for-the-second-time-risk-management-system\/#primaryimage"},"thumbnailUrl":"https:\/\/m2apartners.cz\/wp-content\/uploads\/2022\/09\/2.png","datePublished":"2022-09-30T13:34:00+00:00","dateModified":"2025-03-27T16:05:22+00:00","description":"This article is the second in a series dedicated to the new Regulation (EU) 2017\/745 of the European Parliament and of the Council on medical devices (the \"MDR\"). In the introductory article, which appeared in MT 7\/2019, we looked generally at the obligations arising from the MDR and, in particular, the points at which it will be necessary to comply with the rules set out therein.","breadcrumb":{"@id":"https:\/\/m2apartners.cz\/en\/mdr-for-the-second-time-risk-management-system\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/m2apartners.cz\/en\/mdr-for-the-second-time-risk-management-system\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/m2apartners.cz\/en\/mdr-for-the-second-time-risk-management-system\/#primaryimage","url":"https:\/\/m2apartners.cz\/wp-content\/uploads\/2022\/09\/2.png","contentUrl":"https:\/\/m2apartners.cz\/wp-content\/uploads\/2022\/09\/2.png","width":940,"height":788,"caption":"Syst\u00e9m pro \u0159\u00edzen\u00ed rizik"},{"@type":"BreadcrumbList","@id":"https:\/\/m2apartners.cz\/en\/mdr-for-the-second-time-risk-management-system\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/m2apartners.cz\/en\/"},{"@type":"ListItem","position":2,"name":"MDR for the second time - risk management system"}]},{"@type":"WebSite","@id":"https:\/\/m2apartners.cz\/en\/#website","url":"https:\/\/m2apartners.cz\/en\/","name":"m2apartners.cz","description":"We focus on providing legal services to clients in the pharmaceutical and medical device industries, in corporate matters, in connection with the setting up of internal processes, in matters of zoning and construction law proceedings, in general practice, especially general contract, real estate, family and employment law.","publisher":{"@id":"https:\/\/m2apartners.cz\/en\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/m2apartners.cz\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/m2apartners.cz\/en\/#organization","name":"M2A Partners","url":"https:\/\/m2apartners.cz\/en\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/m2apartners.cz\/en\/#\/schema\/logo\/image\/","url":"https:\/\/m2apartners.cz\/wp-content\/uploads\/2025\/03\/cropped-cropped-FAV_512x512.png","contentUrl":"https:\/\/m2apartners.cz\/wp-content\/uploads\/2025\/03\/cropped-cropped-FAV_512x512.png","width":512,"height":512,"caption":"M2A Partners"},"image":{"@id":"https:\/\/m2apartners.cz\/en\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/m2apartners.cz\/en\/#\/schema\/person\/2737d6d592b954976f2a3fdcb4e8248e","name":"admin3645","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/baf40bb2dd82590384e4496ea9a16e5723a6284ec7fb445ad629f19905b6c337?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/baf40bb2dd82590384e4496ea9a16e5723a6284ec7fb445ad629f19905b6c337?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/baf40bb2dd82590384e4496ea9a16e5723a6284ec7fb445ad629f19905b6c337?s=96&d=mm&r=g","caption":"admin3645"},"sameAs":["https:\/\/m2apartners.cz"]}]}},"_links":{"self":[{"href":"https:\/\/m2apartners.cz\/en\/wp-json\/wp\/v2\/posts\/5958","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/m2apartners.cz\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/m2apartners.cz\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/m2apartners.cz\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/m2apartners.cz\/en\/wp-json\/wp\/v2\/comments?post=5958"}],"version-history":[{"count":1,"href":"https:\/\/m2apartners.cz\/en\/wp-json\/wp\/v2\/posts\/5958\/revisions"}],"predecessor-version":[{"id":5959,"href":"https:\/\/m2apartners.cz\/en\/wp-json\/wp\/v2\/posts\/5958\/revisions\/5959"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/m2apartners.cz\/en\/wp-json\/wp\/v2\/media\/5523"}],"wp:attachment":[{"href":"https:\/\/m2apartners.cz\/en\/wp-json\/wp\/v2\/media?parent=5958"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/m2apartners.cz\/en\/wp-json\/wp\/v2\/categories?post=5958"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/m2apartners.cz\/en\/wp-json\/wp\/v2\/tags?post=5958"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}