{"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":"medtech-products-swiss-industry-under-pressure","status":"publish","type":"post","link":"https:\/\/www.m-q.ch\/en\/medtech-produkte-schweizer-branche-unter-druck\/","title":{"rendered":"MedTech products: Swiss industry under pressure"},"content":{"rendered":"
\"\"
From 26 May, new approval rules for medtech products will apply in the EU. (Image: Unsplash)<\/figcaption><\/figure>\n

On 26 May, new rules for the approval of numerous medtech products will come into force in the EU. If the Joint Committee has not incorporated these rules into the 1999 agreement by then, Switzerland will become a normal third country in this area. Then it may not only be the new medtech products from Switzerland that have to be approved a second time in the EU.<\/p>\n

The Swiss medtech industry could be hit by the deadlock in relations between Switzerland and the EU. The EU refuses to update existing bilateral agreements. This affects in particular the\u00a0Agreement on mutual recognition in relation to conformity assessment<\/a>\u00a0one of the seven Bilateral I agreements. This regulates which regulations are recognised as equivalent in the EU and Switzerland.<\/p>\n

New regulations must be incorporated into the agreement by a joint committee of both sides. This was last done in 2017.<\/p>\n

Rather, according to a\u00a0Report<\/a>\u00a0the \"Neue Z\u00fcrcher Zeitung\", it is possible that existing products for which Swiss approval was previously sufficient will also be re-approved in the EU. This means that seven times more products would be affected by the blockade than previously assumed. In addition, Swiss companies would have to appoint an authorised representative in the EU to take responsibility for the products.<\/p>\n

The EU has considerable leeway in deciding how the Swiss medtech industry will be treated. \"One possible interpretation assumes that in a transitional phase until 2024, even new products must continue to be recognised,\" Peter Studer, at industry association\u00a0Swiss Medtech<\/a>\u00a0responsible for regulation, in a\u00a0Report<\/a>\u00a0of the \"Tages-Anzeiger\". But the uncertainty is weighing on the industry.<\/p>\n

The institutional framework agreement, which is at the heart of the bilateral blockade, remains on shaky ground.<\/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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