{"id":6138,"date":"2022-06-06T12:51:52","date_gmt":"2022-06-06T10:51:52","guid":{"rendered":"https:\/\/www.rapharm.eu\/en\/?p=6138"},"modified":"2022-06-06T13:00:05","modified_gmt":"2022-06-06T11:00:05","slug":"eu-joint-implementation-and-preparedness-plan-for-ivdr-2","status":"publish","type":"post","link":"https:\/\/www.rapharm.eu\/en\/eu-joint-implementation-and-preparedness-plan-for-ivdr-2\/","title":{"rendered":"EU: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices"},"content":{"rendered":"<style type=\"text\/css\"><\/style>\n<p>Switzerland participates in the internal\nmarket of the European Union through the <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A22002A0430%2805%29\">Agreement on Mutual Recognition in\nrelation to conformity assessment (MRA)<\/a>. In the absence of an update of the MRA\nto include Regulation (EU) 2017\/746, the part of the MRA chapter covering in\nvitro diagnostic medical devices ceased to apply as of 26 May 2022. Switzerland\nis thus considered a third country in the field of in vitro diagnostic medical\ndevices. This is also clearly expressed in the <a href=\"https:\/\/ec.europa.eu\/health\/latest-updates\/notice-stakeholders-status-eu-switzerland-mutual-recognition-agreement-mra-vitro-diagnostic-medical-2022-05-24_en\">European Commission&#8217;s notice<\/a> setting out the following\nconsequences for in vitro diagnostics after 26. May 2022 (quote):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>For all new in vitro\ndiagnostic medical devices, Swiss manufacturers will be treated as any other\nthird country manufacturer intending to place its devices on the EU market. In particular,\nin vitro diagnostic medical devices of Swiss manufacturers requiring\ncertification on the basis of a conformity assessment procedure must be\ncertified by conformity assessment bodies established within the EU.<\/li><li>Certificates issued\nunder the MRA by conformity assessment bodies established in Switzerland will\nno longer be recognised as valid in the EU even if they were issued before 26\nMay 2022.<\/li><li>For in vitro diagnostic\nmedical devices placed on the market after 26 May 2022, Swiss manufacturers and\nthird country manufacturers whose authorised representative was previously\nestablished in Switzerland must designate an authorised representative\nestablished in the EU. <\/li><\/ul>\n\n\n\n<p>The consequences are identical to the\nconsequences that apply to medical devices from the entry into force of\nRegulation (EU) 2017\/745 on 26 May 2021 and published in the <a href=\"https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/IP_21_2684\">European Commission Notice<\/a> of 26 May 2021.<\/p>\n\n\n\n<p>On 19 May 2021, the Swiss Federal Council\nadopted an amendment to the Swiss Medical Devices Ordinance (MedDO)\nestablishing conditions for trade of medical devices covered by EU issued\ncertificates on the Swiss market. This includes the recognition of existing\ncertificates issued under the MRA by conformity assessment bodies established\nin the EU and transitional timelines for the designation of a representative in\nSwitzerland for EU\/EEA manufacturers of medical devices.<\/p>\n\n\n\n<p>See <a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/news\/mitteilungen\/neue-regulierug-mep-26-05-2021.html\">here<\/a> for more information on MedDO.&nbsp;<\/p>\n\n\n\n<p><strong>Do you need additional knowledge or assistance in\nmeeting 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>, we 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:\/\/ec.europa.eu\/commission\/presscorner\/api\/files\/document\/print\/en\/ip_21_2684\/IP_21_2684_EN.pdf\">Notice to Stakeholders: Status\nof the EU-Switzerland Mutual Recognition Agreement for Medical Devices<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/health\/document\/download\/8dd260fd-0b67-415b-bf1e-36bdf8681674_en?filename=md_eu-switzerland_mra_in-vitro-diagnostic.pdf\">Notice to Stakeholders: Status\nof the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro\ndiagnostic medical devices<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Switzerland participates in the internal market of the European Union through the Agreement on Mutual Recognition in relation to conformity assessment (MRA). In the absence of an update of the MRA to include Regulation (EU) 2017\/746, the part of the MRA chapter covering in vitro diagnostic medical devices ceased to apply as of 26 May&#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-6138","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: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices - 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-stanje-sporazuma-o-vzajemnem-priznavanju-mra-med-eu-in-svico-za-in-vitro-diagnosticne-medicinske-pripomocke\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"EU: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices - raPHARM\" \/>\n<meta property=\"og:description\" content=\"Switzerland participates in the internal market of the European Union through the Agreement on Mutual Recognition in relation to conformity assessment (MRA). In the absence of an update of the MRA to include Regulation (EU) 2017\/746, the part of the MRA chapter covering in vitro diagnostic medical devices ceased to apply as of 26 May...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.rapharm.eu\/eu-stanje-sporazuma-o-vzajemnem-priznavanju-mra-med-eu-in-svico-za-in-vitro-diagnosticne-medicinske-pripomocke\/\" \/>\n<meta property=\"og:site_name\" content=\"raPHARM\" \/>\n<meta property=\"article:published_time\" content=\"2022-06-06T10:51:52+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-06-06T11:00:05+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-stanje-sporazuma-o-vzajemnem-priznavanju-mra-med-eu-in-svico-za-in-vitro-diagnosticne-medicinske-pripomocke\/\",\"url\":\"https:\/\/www.rapharm.eu\/eu-stanje-sporazuma-o-vzajemnem-priznavanju-mra-med-eu-in-svico-za-in-vitro-diagnosticne-medicinske-pripomocke\/\",\"name\":\"EU: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices - raPHARM\",\"isPartOf\":{\"@id\":\"https:\/\/www.rapharm.eu\/#website\"},\"datePublished\":\"2022-06-06T10:51:52+00:00\",\"dateModified\":\"2022-06-06T11:00:05+00:00\",\"author\":{\"@id\":\"https:\/\/www.rapharm.eu\/#\/schema\/person\/ba2051c1c51d2328945ac838b3f1d7e1\"},\"breadcrumb\":{\"@id\":\"https:\/\/www.rapharm.eu\/eu-stanje-sporazuma-o-vzajemnem-priznavanju-mra-med-eu-in-svico-za-in-vitro-diagnosticne-medicinske-pripomocke\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.rapharm.eu\/eu-stanje-sporazuma-o-vzajemnem-priznavanju-mra-med-eu-in-svico-za-in-vitro-diagnosticne-medicinske-pripomocke\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.rapharm.eu\/eu-stanje-sporazuma-o-vzajemnem-priznavanju-mra-med-eu-in-svico-za-in-vitro-diagnosticne-medicinske-pripomocke\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.rapharm.eu\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"EU: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices\"}]},{\"@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: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices - 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-stanje-sporazuma-o-vzajemnem-priznavanju-mra-med-eu-in-svico-za-in-vitro-diagnosticne-medicinske-pripomocke\/","og_locale":"en_US","og_type":"article","og_title":"EU: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices - raPHARM","og_description":"Switzerland participates in the internal market of the European Union through the Agreement on Mutual Recognition in relation to conformity assessment (MRA). In the absence of an update of the MRA to include Regulation (EU) 2017\/746, the part of the MRA chapter covering in vitro diagnostic medical devices ceased to apply as of 26 May...","og_url":"https:\/\/www.rapharm.eu\/eu-stanje-sporazuma-o-vzajemnem-priznavanju-mra-med-eu-in-svico-za-in-vitro-diagnosticne-medicinske-pripomocke\/","og_site_name":"raPHARM","article_published_time":"2022-06-06T10:51:52+00:00","article_modified_time":"2022-06-06T11:00:05+00:00","author":"rapharm","twitter_card":"summary_large_image","twitter_misc":{"Written by":"rapharm","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.rapharm.eu\/eu-stanje-sporazuma-o-vzajemnem-priznavanju-mra-med-eu-in-svico-za-in-vitro-diagnosticne-medicinske-pripomocke\/","url":"https:\/\/www.rapharm.eu\/eu-stanje-sporazuma-o-vzajemnem-priznavanju-mra-med-eu-in-svico-za-in-vitro-diagnosticne-medicinske-pripomocke\/","name":"EU: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices - raPHARM","isPartOf":{"@id":"https:\/\/www.rapharm.eu\/#website"},"datePublished":"2022-06-06T10:51:52+00:00","dateModified":"2022-06-06T11:00:05+00:00","author":{"@id":"https:\/\/www.rapharm.eu\/#\/schema\/person\/ba2051c1c51d2328945ac838b3f1d7e1"},"breadcrumb":{"@id":"https:\/\/www.rapharm.eu\/eu-stanje-sporazuma-o-vzajemnem-priznavanju-mra-med-eu-in-svico-za-in-vitro-diagnosticne-medicinske-pripomocke\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.rapharm.eu\/eu-stanje-sporazuma-o-vzajemnem-priznavanju-mra-med-eu-in-svico-za-in-vitro-diagnosticne-medicinske-pripomocke\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.rapharm.eu\/eu-stanje-sporazuma-o-vzajemnem-priznavanju-mra-med-eu-in-svico-za-in-vitro-diagnosticne-medicinske-pripomocke\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.rapharm.eu\/en\/"},{"@type":"ListItem","position":2,"name":"EU: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices"}]},{"@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\/"}]}},"_links":{"self":[{"href":"https:\/\/www.rapharm.eu\/en\/wp-json\/wp\/v2\/posts\/6138","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.rapharm.eu\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.rapharm.eu\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.rapharm.eu\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.rapharm.eu\/en\/wp-json\/wp\/v2\/comments?post=6138"}],"version-history":[{"count":4,"href":"https:\/\/www.rapharm.eu\/en\/wp-json\/wp\/v2\/posts\/6138\/revisions"}],"predecessor-version":[{"id":6144,"href":"https:\/\/www.rapharm.eu\/en\/wp-json\/wp\/v2\/posts\/6138\/revisions\/6144"}],"wp:attachment":[{"href":"https:\/\/www.rapharm.eu\/en\/wp-json\/wp\/v2\/media?parent=6138"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.rapharm.eu\/en\/wp-json\/wp\/v2\/categories?post=6138"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.rapharm.eu\/en\/wp-json\/wp\/v2\/tags?post=6138"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}