{"id":3872,"date":"2020-02-17T11:06:40","date_gmt":"2020-02-17T10:06:40","guid":{"rendered":"https:\/\/www.m-q.ch\/?p=3872"},"modified":"2020-02-25T13:47:56","modified_gmt":"2020-02-25T12:47:56","slug":"produits-medtech-branche-suisse-sous-pression","status":"publish","type":"post","link":"https:\/\/www.m-q.ch\/fr\/medtech-produkte-schweizer-branche-unter-druck\/","title":{"rendered":"Les produits MedTech : L'industrie suisse sous pression"},"content":{"rendered":"
\"\"
\u00c0 partir du 26 mai, de nouvelles r\u00e8gles d'approbation des produits de technologie m\u00e9dicale s'appliqueront dans l'UE. (Image : Unsplash)<\/figcaption><\/figure>\n

Le 26 mai, de nouvelles r\u00e8gles pour l'approbation de nombreux produits de technologie m\u00e9dicale entreront en vigueur dans l'UE. Si le comit\u00e9 mixte n'a pas int\u00e9gr\u00e9 ces r\u00e8gles dans l'accord de 1999 d'ici l\u00e0, la Suisse deviendra un pays tiers normal dans ce domaine. Il se peut alors que les nouveaux produits medtech suisses ne soient pas les seuls \u00e0 devoir \u00eatre approuv\u00e9s une deuxi\u00e8me fois dans l'UE.<\/p>\n

L'industrie suisse des technologies m\u00e9dicales pourrait \u00eatre touch\u00e9e par l'impasse dans laquelle se trouvent les relations entre la Suisse et l'UE. L'UE refuse d'actualiser les accords bilat\u00e9raux existants. Cela concerne en particulier\u00a0Accord sur la reconnaissance mutuelle en mati\u00e8re d'\u00e9valuation de la conformit\u00e9<\/a>\u00a0l'un des sept accords bilat\u00e9raux I. Il s'agit de d\u00e9terminer quelles r\u00e9glementations sont reconnues comme \u00e9quivalentes dans l'UE et en Suisse.<\/p>\n

Les nouveaux r\u00e8glements doivent \u00eatre int\u00e9gr\u00e9s \u00e0 l'accord par un comit\u00e9 mixte des deux parties. La derni\u00e8re fois que cela a \u00e9t\u00e9 fait, c'\u00e9tait en 2017.<\/p>\n

Au contraire, selon un\u00a0Rapport<\/a>\u00a0la \"Neue Z\u00fcrcher Zeitung\", il est possible que des produits existants pour lesquels l'approbation suisse \u00e9tait auparavant suffisante soient \u00e9galement r\u00e9-approuv\u00e9s dans l'UE. Cela signifie que sept fois plus de produits seraient touch\u00e9s par le blocus que ce que l'on supposait auparavant. En outre, les entreprises suisses devront d\u00e9signer un repr\u00e9sentant autoris\u00e9 dans l'UE pour assumer la responsabilit\u00e9 des produits.<\/p>\n

L'UE dispose d'une marge de man\u0153uvre consid\u00e9rable pour d\u00e9cider de la mani\u00e8re dont l'industrie suisse des technologies m\u00e9dicales sera trait\u00e9e. \"Une interpr\u00e9tation possible suppose que dans une phase transitoire jusqu'en 2024, m\u00eame les nouveaux produits doivent continuer \u00e0 \u00eatre reconnus\", Peter Studer, \u00e0 l'association de l'industrie\u00a0Le Medtech suisse<\/a>\u00a0responsable de la r\u00e9glementation, dans un\u00a0Rapport<\/a>\u00a0du \"Tages-Anzeiger\". Mais l'incertitude p\u00e8se sur l'industrie.<\/p>\n

L'accord-cadre institutionnel, qui est au c\u0153ur du blocus bilat\u00e9ral, reste sur des bases fragiles.<\/p>","protected":false},"excerpt":{"rendered":"

Am 26. Mai treten in der EU neue Regeln f\u00fcr die Zulassung zahlreicher MedTech-Produkte in Kraft. Wenn bis dahin der gemischte Ausschuss diese Regeln nicht in das Abkommen von 1999 aufgenommen hat, wird die Schweiz in diesem Bereich zu einem normalen Drittstaat. Dann m\u00fcssen wom\u00f6glich nicht nur die neuen Medtech-Produkte aus der Schweiz in der […]<\/p>\n","protected":false},"author":35,"featured_media":3873,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[3303],"tags":[4234,4020,4232,4233],"class_list":["post-3872","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-qualitaetsmanagement","tag-blockade","tag-med-tech","tag-rahmenabkommen","tag-schweiz-eu"],"acf":[],"yoast_head":"\nMedTech-Produkte: Schweizer Branche unter Druck - MQ Management und Qualit\u00e4t<\/title>\n<meta name=\"description\" content=\"Ab dem 26. 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Das k\u00f6nnte die Schweizer Medtech Branche auf den Kopf stellen.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.m-q.ch\/fr\/produits-medtech-branche-suisse-sous-pression\/\" \/>\n<meta property=\"og:site_name\" content=\"MQ Management und Qualit\u00e4t\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/ManagementUndQualitaet\" \/>\n<meta property=\"article:published_time\" content=\"2020-02-17T10:06:40+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2020-02-25T12:47:56+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.m-q.ch\/wp-content\/uploads\/2020\/02\/health_MQ-management-u-qualitaet.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1042\" \/>\n\t<meta property=\"og:image:height\" content=\"703\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Roger Str\u00e4ssle\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u00c9crit par\" \/>\n\t<meta name=\"twitter:data1\" content=\"Roger Str\u00e4ssle\" \/>\n\t<meta name=\"twitter:label2\" content=\"Dur\u00e9e de lecture estim\u00e9e\" \/>\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\":\"Article\",\"@id\":\"https:\/\/www.m-q.ch\/medtech-produkte-schweizer-branche-unter-druck\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.m-q.ch\/medtech-produkte-schweizer-branche-unter-druck\/\"},\"author\":{\"name\":\"Roger Str\u00e4ssle\",\"@id\":\"https:\/\/www.m-q.ch\/fr\/#\/schema\/person\/47d540e081acd98ccbeb69b55df653d7\"},\"headline\":\"MedTech-Produkte: Schweizer Branche unter Druck\",\"datePublished\":\"2020-02-17T10:06:40+00:00\",\"dateModified\":\"2020-02-25T12:47:56+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.m-q.ch\/medtech-produkte-schweizer-branche-unter-druck\/\"},\"wordCount\":315,\"publisher\":{\"@id\":\"https:\/\/www.m-q.ch\/fr\/#organization\"},\"image\":{\"@id\":\"https:\/\/www.m-q.ch\/medtech-produkte-schweizer-branche-unter-druck\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.m-q.ch\/wp-content\/uploads\/2020\/02\/health_MQ-management-u-qualitaet.jpg\",\"keywords\":[\"Blockade\",\"Med Tech\",\"Rahmenabkommen\",\"Schweiz-EU\"],\"articleSection\":[\"Qualit\u00e4tsmanagement\"],\"inLanguage\":\"fr-FR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.m-q.ch\/medtech-produkte-schweizer-branche-unter-druck\/\",\"url\":\"https:\/\/www.m-q.ch\/medtech-produkte-schweizer-branche-unter-druck\/\",\"name\":\"MedTech-Produkte: Schweizer Branche unter Druck - MQ Management und Qualit\u00e4t\",\"isPartOf\":{\"@id\":\"https:\/\/www.m-q.ch\/fr\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.m-q.ch\/medtech-produkte-schweizer-branche-unter-druck\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.m-q.ch\/medtech-produkte-schweizer-branche-unter-druck\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.m-q.ch\/wp-content\/uploads\/2020\/02\/health_MQ-management-u-qualitaet.jpg\",\"datePublished\":\"2020-02-17T10:06:40+00:00\",\"dateModified\":\"2020-02-25T12:47:56+00:00\",\"description\":\"Ab dem 26. 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