{"id":3461,"date":"2017-05-04T21:34:32","date_gmt":"2017-05-04T20:34:32","guid":{"rendered":"http:\/\/www.hex-group.fr\/nl_BE\/?p=3461"},"modified":"2017-05-04T21:34:32","modified_gmt":"2017-05-04T20:34:32","slug":"de-versterkt-het-toezicht-op-de-medische-hulpmiddelen","status":"publish","type":"post","link":"https:\/\/www.hex-group.eu\/nl_BE\/de-versterkt-het-toezicht-op-de-medische-hulpmiddelen\/","title":{"rendered":"De EU versterkt het toezicht op de medische hulpmiddelen"},"content":{"rendered":"<p><strong>De maatregelen moeten uiterlijk in 2020 van kracht zijn.<\/strong><\/p>\n<img decoding=\"async\" class=\"alignleft size-thumbnail wp-image-3459\" src=\"https:\/\/www.hex-group.fr\/wp-content\/uploads\/2017\/05\/europe-drapeau-150x150.jpg\" alt=\"europe-drapeau\" width=\"150\" height=\"150\" srcset=\"https:\/\/www.hex-group.eu\/wp-content\/uploads\/2017\/05\/europe-drapeau-150x150.jpg 150w, https:\/\/www.hex-group.eu\/wp-content\/uploads\/2017\/05\/europe-drapeau-125x125.jpg 125w\" sizes=\"(max-width: 150px) 100vw, 150px\" \/>\n<p>Medische hulpmiddelen zoals prothesen en hiv-tests zullen onderworpen worden aan <strong>strengere controles binnen de Europese unie op grond van een nieuwe Europese wetgeving, die werd goedgekeurd naar aanleiding van bepaalde schandalen zoals dat van de PIP-borstprotheses.<\/strong><\/p>\n<p><strong>Het Europees Parlement heeft op 5 april, <\/strong>in de tweede lezing, <strong>twee wetsvoorstellen over medische hulpmiddelen goedgekeurd <\/strong>zoals de borstimplantaten en de heupprothesen, en over in vitro diagnosehulpmiddelen, zoals zwangerschapstests.<\/p>\n<p>De nieuwe wetgeving, waarover bijna vijf jaar onderhandeld werd, voorziet strengere controles van de certificerende instanties die verplicht zijn te werken met medisch gekwalificeerde mensen, willekeurige inspecties van fabrikanten nadat de hulpmiddelen op de markt gebracht zijn, en de invoering van een \u201cImplantaatkaart\u201d voor de pati\u00ebnten, om de traceerbaarheid van de producten te verhogen.<\/p>\n<p><strong>De maatregelen inzake de medische apparatuur moeten uiterlijk in 2020 van kracht zijn,<\/strong> en die inzake de diagnoseapparatuur uiterlijk in 2022.<\/p>\n<p><strong>Bron<\/strong>\u00a0<a href=\"http:\/\/www.processpropre.fr\">www.processpropre.fr<\/a>\u00a0\/\u00a0Ouest France<\/p>\n","protected":false},"excerpt":{"rendered":"<p>De maatregelen moeten uiterlijk in 2020 van kracht zijn. Medische hulpmiddelen zoals prothesen en hiv-tests zullen onderworpen worden aan strengere controles binnen de Europese unie op grond van een nieuwe Europese wetgeving, die werd goedgekeurd naar aanleiding van bepaalde schandalen zoals dat van de PIP-borstprotheses. Het Europees Parlement heeft op 5 april, in de tweede&#8230;  <a class=\"excerpt-read-more\" href=\"https:\/\/www.hex-group.eu\/nl_BE\/de-versterkt-het-toezicht-op-de-medische-hulpmiddelen\/\" title=\"Read De EU versterkt het toezicht op de medische hulpmiddelen\">Read more &raquo;<\/a><\/p>\n","protected":false},"author":21,"featured_media":3459,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"content-type":"","footnotes":""},"categories":[127],"tags":[],"class_list":["post-3461","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-nl_be"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>De EU versterkt het toezicht op de medische hulpmiddelen - HeX Group<\/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.hex-group.eu\/nl_BE\/de-versterkt-het-toezicht-op-de-medische-hulpmiddelen\/\" \/>\n<meta property=\"og:locale\" content=\"nl_BE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"De EU versterkt het toezicht op de medische hulpmiddelen - HeX Group\" \/>\n<meta property=\"og:description\" content=\"De maatregelen moeten uiterlijk in 2020 van kracht zijn. Medische hulpmiddelen zoals prothesen en hiv-tests zullen onderworpen worden aan strengere controles binnen de Europese unie op grond van een nieuwe Europese wetgeving, die werd goedgekeurd naar aanleiding van bepaalde schandalen zoals dat van de PIP-borstprotheses. Het Europees Parlement heeft op 5 april, in de tweede... 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