{"id":3799,"date":"2019-02-12T08:00:01","date_gmt":"2019-02-12T07:00:01","guid":{"rendered":"https:\/\/news.save.ch\/?p=3799"},"modified":"2023-03-14T09:04:04","modified_gmt":"2023-03-14T08:04:04","slug":"medizinskandal-hoehere-sicherheit-von-medizinprodukten","status":null,"type":"post","link":"https:\/\/news.save.ch\/en\/medizinskandal-hoehere-sicherheit-von-medizinprodukten\/","title":{"rendered":"Medical scandal: Increased safety of medical devices"},"content":{"rendered":"<figure id=\"attachment_3801\" aria-describedby=\"caption-attachment-3801\" style=\"width: 680px\" class=\"wp-caption alignnone\"><img loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-3801\" src=\"http:\/\/develop.safety-plus.ch\/wp-content\/uploads\/2019\/02\/Depositphotos_BranislavP.jpg\" alt=\"\" width=\"680\" height=\"432\" \/><figcaption id=\"caption-attachment-3801\" class=\"wp-caption-text\">Draft law aims to improve the safety and quality of medical devices and thus patient safety in Switzerland. Pictured, breast implants. \u00a9 Depositphotos\/BranislavP<\/figcaption><\/figure>\n<p>Several incidents and scandals involving medical devices such as leaking <a href=\"https:\/\/news.save.ch\/en\/neue-high-tech-elektroden\/\" target=\"_blank\" rel=\"noopener\">Silicone<\/a>-In Europe, doubts about the system for controlling medical devices arose due to the failure of breast implants and defective hip prostheses. As a result, the EU modernized its legal framework in May 2017 and made it significantly stricter in two new EU regulations.<\/p>\n<p>Switzerland currently has equivalent regulation for medical devices as the EU. The Switzerland-EU agreement on mutual recognition of conformity assessments allows Switzerland to participate in European market surveillance. By adapting Swiss medical device legislation to the stricter EU regulations, the safety and quality of medical devices should also be improved in Switzerland.<\/p>\n<p>This requires adjustments in the <a href=\"https:\/\/news.save.ch\/en\/bund-will-engpaesse-bei-medikamenten-und-impfstoffen-verhindern\/\" target=\"_blank\" rel=\"noopener\">Therapeutic Products Act<\/a> (HMG) and in the Human Research Act (HFG) are necessary. The requirements will be tightened for all players involved. In the case of high-risk products, for example, manufacturers must substantiate the benefits and usefulness of the products with clinical data and assess their safety. The criteria for approval and monitoring of clinical trials and performance testing will be made stricter. At the same time, the requirements and responsibilities for the competent authorities as well as for the privately organized conformity assessment bodies will be made much stricter. Market surveillance by <a href=\"https:\/\/news.save.ch\/en\/operation-pangea-gegen-illegalen-heilmittelhandel\/\" target=\"_blank\" rel=\"noopener\">Swissmedic<\/a> will be strengthened. Furthermore, the clear identification of all products is to enable their complete traceability. In addition, relevant data will be made available to the public in a comprehensible form within the framework of a central European database for medical devices.<\/p>\n<p><strong>More info:<\/strong><\/p>\n<p><a href=\"https:\/\/www.admin.ch\/gov\/de\/start\/dokumentation\/medienmitteilungen.msg-id-73160.html\" target=\"_blank\" rel=\"noopener\"><strong>www.admin.ch<\/strong><\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Mehrere Vorkommnisse und Skandale mit Medizinprodukten wie undichte Silikon-Brustimplantate oder fehlerhafte H\u00fcftprothesen liessen in Europa Zweifel am System zur Kontrolle von Medizinprodukten aufkommen. In der Folge hat die EU im Mai 2017 ihren Rechtsrahmen modernisiert und in zwei neuen EU-Verordnungen deutlich strenger ausgestaltet. Die Schweiz verf\u00fcgt derzeit \u00fcber eine gleichwertige Regulierung f\u00fcr Medizinprodukte wie die [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":16310,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"pgc_sgb_lightbox_settings":"","footnotes":""},"categories":[1,3314],"tags":[1775,168,2165,149,2523,141,2719,2739,310,3059],"class_list":["post-3799","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-allgemein","category-health-safety","tag-betriebliches-gesundheitsmanagement","tag-bundesrat","tag-gesundheitsfoerderung","tag-gesundheitsschutz","tag-medizinprodukte","tag-praevention","tag-prothese","tag-qualitaet","tag-sicherheit","tag-swissmedic"],"acf":[],"hkrextid":null,"publication":null,"issue":null,"workflow":null,"startPage":null,"spitzmarke":null,"_posts_by_tag_page_fields":{"widget_title":"","widget_tags":""},"_at_widget":"1","_yoast_wpseo_primary_category":"1","_yoast_wpseo_focuskw_text_input":"Medizinskandal","_yoast_wpseo_opengraph-image":null,"_yoast_wpseo_opengraph-description":null,"_yoast_wpseo_opengraph-title":null,"enclosure":null,"_yoast_wpseo_twitter-title":null,"_yoast_wpseo_twitter-description":null,"_yoast_wpseo_twitter-image":null,"_wp_old_slug":null,"_yoast_wpseo_title":null,"_yoast_wpseo_canonical":null,"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - 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