{"id":15825,"date":"2020-09-22T11:39:13","date_gmt":"2020-09-22T09:39:13","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=15825"},"modified":"2023-01-24T14:59:06","modified_gmt":"2023-01-24T13:59:06","slug":"switzerland-harmonization-regulatory-system-to-mdr","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/","title":{"rendered":"SWITZERLAND: harmonization of the regulatory system to MDR is underway"},"content":{"rendered":"\n

Last July 2020 the Swiss Federal Council approved the revision of the Medical Devices Ordinance (MedDO<\/strong>), along with the new Ordinance on Clinical Trials for Medical Devices (ClinO-MD<\/strong>). Both ordinances will take effect on May 26, 2021 <\/strong>to align with the EU Medical Devices Regulation MDR (EU) 2017\/745 application date.<\/p>\n\n\n\n

\"Harmonization
Harmonization of the regulatory system to MDR is underway<\/figcaption><\/figure>\n\n\n\n

As the equivalence of the relevant legal requirements is a prerequisite for the mutual recognition agreement (MRA) between Switzerland and the EU, the Swiss Federal Council intends to align the MedDO to adapt it to the MDR (EU) 2017\/745 and to safeguard harmonization of regulatory system with the rest of Europe. <\/p>\n\n\n\n

The\nSwiss regulation on medical devices is therefore being amended. It is also\nexpected that the provisions relating to in vitro diagnostic medical devices\nwill be included in a separate regulation that will be harmonized with the In\nVitro Diagnostic Medical Devices Regulation IVDR (EU) 2017\/746. <\/p>\n\n\n\n

The\napplication date of the IVDR (EU) 2017\/746 is set for May 26, 2022, while the consultation\non implementing legislation is scheduled for summer 2021. <\/p>\n\n\n\n

Discover what we can do for you!<\/strong><\/p>\n\n\n\n

Thema offers strategic – regulatory consulting services<\/strong><\/a> for companies operating in the field of medical devices and IVD<\/strong>.<\/p>\n\n\n\n

Contact us<\/a><\/strong> <\/a>to know all the details and if you want to stay up to date Thema activities, subscribe to our newsletter<\/strong><\/a>! <\/p>\n\n\n\n

Source:<\/em> <\/p>\n\n\n\n

https:\/\/www.admin.ch\/gov\/de\/start.html<\/a> <\/p>\n\n\n\n

https:\/\/bit.ly\/3bKRRtZ<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Last July 2020 the Swiss Federal Council approved the revision of the Medical Devices Ordinance (MedDO), along with the new Ordinance […]<\/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":[2],"tags":[],"class_list":["post-15825","post","type-post","status-publish","format-standard","hentry","category-news-en"],"acf":[],"yoast_head":"\nSWITZERLAND: harmonization of regulatory system to MDR is underway<\/title>\n<meta name=\"description\" content=\"The harmonization of regulatory system is underway in Switzerland to align with the European Medical Device Regulation MDR (EU) 2017\/745\" \/>\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.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"SWITZERLAND: harmonization of regulatory system to MDR is underway\" \/>\n<meta property=\"og:description\" content=\"The harmonization of regulatory system is underway in Switzerland to align with the European Medical Device Regulation MDR (EU) 2017\/745\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/\" \/>\n<meta property=\"og:site_name\" content=\"Thema Med\" \/>\n<meta property=\"article:published_time\" content=\"2020-09-22T09:39:13+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-01-24T13:59:06+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/09\/sw-sistema-normativo-mdr-1024x536.png\" \/>\n<meta name=\"author\" content=\"redazione\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"redazione\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/\"},\"author\":{\"name\":\"redazione\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e\"},\"headline\":\"SWITZERLAND: harmonization of the regulatory system to MDR is underway\",\"datePublished\":\"2020-09-22T09:39:13+00:00\",\"dateModified\":\"2023-01-24T13:59:06+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/\"},\"wordCount\":241,\"publisher\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/09\/sw-sistema-normativo-mdr-1024x536.png\",\"articleSection\":[\"News\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/\",\"url\":\"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/\",\"name\":\"SWITZERLAND: harmonization of regulatory system to MDR is underway\",\"isPartOf\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/09\/sw-sistema-normativo-mdr-1024x536.png\",\"datePublished\":\"2020-09-22T09:39:13+00:00\",\"dateModified\":\"2023-01-24T13:59:06+00:00\",\"description\":\"The harmonization of regulatory system is underway in Switzerland to align with the European Medical Device Regulation MDR (EU) 2017\/745\",\"breadcrumb\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/#primaryimage\",\"url\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/09\/sw-sistema-normativo-mdr-1024x536.png\",\"contentUrl\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/09\/sw-sistema-normativo-mdr-1024x536.png\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"http:\/\/www.thema-med.com\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"SWITZERLAND: harmonization of the regulatory system to MDR is underway\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#website\",\"url\":\"https:\/\/www.thema-med.com\/en\/\",\"name\":\"Thema Med\",\"description\":\"Quality and Regulatory Affairs for Medical Devices\",\"publisher\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.thema-med.com\/en\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":[\"Organization\",\"Place\"],\"@id\":\"https:\/\/www.thema-med.com\/en\/#organization\",\"name\":\"Thema\",\"alternateName\":\"Thema\",\"url\":\"https:\/\/www.thema-med.com\/en\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png\",\"contentUrl\":\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png\",\"width\":2440,\"height\":2851,\"caption\":\"Thema\"},\"image\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.linkedin.com\/company\/thema-s-r-l-\/\"],\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e\",\"name\":\"redazione\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g\",\"caption\":\"redazione\"},\"sameAs\":[\"http:\/\/www.thema-med.eu\"],\"url\":\"https:\/\/www.thema-med.com\/en\/author\/emanuele\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"SWITZERLAND: harmonization of regulatory system to MDR is underway","description":"The harmonization of regulatory system is underway in Switzerland to align with the European Medical Device Regulation MDR (EU) 2017\/745","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.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/","og_locale":"en_US","og_type":"article","og_title":"SWITZERLAND: harmonization of regulatory system to MDR is underway","og_description":"The harmonization of regulatory system is underway in Switzerland to align with the European Medical Device Regulation MDR (EU) 2017\/745","og_url":"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/","og_site_name":"Thema Med","article_published_time":"2020-09-22T09:39:13+00:00","article_modified_time":"2023-01-24T13:59:06+00:00","og_image":[{"url":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/09\/sw-sistema-normativo-mdr-1024x536.png","type":"","width":"","height":""}],"author":"redazione","twitter_card":"summary_large_image","twitter_misc":{"Written by":"redazione","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/#article","isPartOf":{"@id":"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/"},"author":{"name":"redazione","@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e"},"headline":"SWITZERLAND: harmonization of the regulatory system to MDR is underway","datePublished":"2020-09-22T09:39:13+00:00","dateModified":"2023-01-24T13:59:06+00:00","mainEntityOfPage":{"@id":"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/"},"wordCount":241,"publisher":{"@id":"https:\/\/www.thema-med.com\/en\/#organization"},"image":{"@id":"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/#primaryimage"},"thumbnailUrl":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/09\/sw-sistema-normativo-mdr-1024x536.png","articleSection":["News"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/","url":"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/","name":"SWITZERLAND: harmonization of regulatory system to MDR is underway","isPartOf":{"@id":"https:\/\/www.thema-med.com\/en\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/#primaryimage"},"image":{"@id":"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/#primaryimage"},"thumbnailUrl":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/09\/sw-sistema-normativo-mdr-1024x536.png","datePublished":"2020-09-22T09:39:13+00:00","dateModified":"2023-01-24T13:59:06+00:00","description":"The harmonization of regulatory system is underway in Switzerland to align with the European Medical Device Regulation MDR (EU) 2017\/745","breadcrumb":{"@id":"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/#primaryimage","url":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/09\/sw-sistema-normativo-mdr-1024x536.png","contentUrl":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/09\/sw-sistema-normativo-mdr-1024x536.png"},{"@type":"BreadcrumbList","@id":"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"http:\/\/www.thema-med.com\/en\/"},{"@type":"ListItem","position":2,"name":"SWITZERLAND: harmonization of the regulatory system to MDR is underway"}]},{"@type":"WebSite","@id":"https:\/\/www.thema-med.com\/en\/#website","url":"https:\/\/www.thema-med.com\/en\/","name":"Thema Med","description":"Quality and Regulatory Affairs for Medical Devices","publisher":{"@id":"https:\/\/www.thema-med.com\/en\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.thema-med.com\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":["Organization","Place"],"@id":"https:\/\/www.thema-med.com\/en\/#organization","name":"Thema","alternateName":"Thema","url":"https:\/\/www.thema-med.com\/en\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/logo\/image\/","url":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png","contentUrl":"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/11\/logo-Themasrl-COLOR-hires-2440.png","width":2440,"height":2851,"caption":"Thema"},"image":{"@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.linkedin.com\/company\/thema-s-r-l-\/"],"mainEntityOfPage":{"@id":"https:\/\/www.thema-med.com\/en\/2020\/09\/22\/switzerland-harmonization-regulatory-system-to-mdr\/"}},{"@type":"Person","@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e","name":"redazione","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.thema-med.com\/en\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/b256f44c95829224dda80aff96bb893da058966fe2e8b7b58ece2b0d74ffa04d?s=96&d=mm&r=g","caption":"redazione"},"sameAs":["http:\/\/www.thema-med.eu"],"url":"https:\/\/www.thema-med.com\/en\/author\/emanuele\/"}]}},"_links":{"self":[{"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/posts\/15825","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/comments?post=15825"}],"version-history":[{"count":1,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/posts\/15825\/revisions"}],"predecessor-version":[{"id":26752,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/posts\/15825\/revisions\/26752"}],"wp:attachment":[{"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/media?parent=15825"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/categories?post=15825"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/tags?post=15825"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}