{"id":42593,"date":"2020-02-12T15:45:01","date_gmt":"2020-02-12T14:45:01","guid":{"rendered":"https:\/\/fhi.nl\/nieuws\/meldplicht-voor-fabrikanten-medische-hulpmiddelen-is-niet-haalbaar\/"},"modified":"2024-07-10T14:33:02","modified_gmt":"2024-07-10T12:33:02","slug":"meldplicht-voor-fabrikanten-medische-hulpmiddelen-is-niet-haalbaar","status":"publish","type":"news","link":"https:\/\/fhi.nl\/en\/news\/meldplicht-voor-fabrikanten-medische-hulpmiddelen-is-niet-haalbaar\/","title":{"rendered":"Reporting obligation for medical device manufacturers &#039;is not feasible&#039;"},"content":{"rendered":"<header id=\"header\" class=\"header header--low\">\n\n\t\n\t\t\t<div class=\"header__background header__background--graphic\"><\/div>\n\t\n\t<div class=\"container\">\n\t\t<div class=\"header__content\">\n\t\t\t<div class=\"header__first header__first--alone\">\n\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t<h1 class=\"header__title\" >\n\t\t\t\t\tReporting obligation for medical device manufacturers &#039;is not feasible&#039;\t\t\t\t<\/h1>\n\n\t\t\t\t<div class=\"header__dots-line\">\n\t\t\t\t\t<svg width=\"431\" height=\"9\" viewbox=\"0 0 431 9\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M430.799 4.192a1.136 1.136 0 1 1-2.272-.001 1.136 1.136 0 0 1 2.272 0Zm-27.272 0a1.135 1.135 0 1 1-2.27 0 1.135 1.135 0 0 1 2.27 0Zm-27.27 0a1.136 1.136 0 1 1-2.272-.001 1.136 1.136 0 0 1 2.272 0Zm-27.272 0a1.39 1.39 0 1 1-2.78 0 1.39 1.39 0 0 1 2.78 0Zm-27.78 0a1.645 1.645 0 1 1-3.29 0 1.645 1.645 0 0 1 3.29 0Zm-28.29 0a1.9 1.9 0 1 1-3.799 0 1.9 1.9 0 0 1 3.799 0Zm-28.799 0a2.154 2.154 0 1 1-4.308 0 2.154 2.154 0 0 1 4.308 0Zm-29.308 0a2.41 2.41 0 1 1-4.819 0 2.41 2.41 0 0 1 4.819 0Zm-29.819 0a2.663 2.663 0 1 1-5.326.001 2.663 2.663 0 0 1 5.326-.001Zm-30.327 0a2.919 2.919 0 1 1-5.837 0 2.919 2.919 0 0 1 5.837 0Zm-30.837 0a3.173 3.173 0 1 1-6.345.001 3.173 3.173 0 0 1 6.345 0Zm-31.346 0a3.428 3.428 0 1 1-6.856 0 3.428 3.428 0 0 1 6.856 0Zm-31.856 0a3.683 3.683 0 1 1-7.365 0 3.683 3.683 0 0 1 7.365 0Zm-32.365 0a3.937 3.937 0 1 1-7.875 0 3.937 3.937 0 0 1 7.875 0Zm-32.874 0a4.192 4.192 0 1 1-8.384 0 4.192 4.192 0 0 1 8.384 0Z\" fill=\"#FFF960\"\/><\/svg>\t\t\t\t<\/div>\n\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\n\t\t\t\n\t\t<\/div>\n\t<\/div>\n<\/header>\n\n\t<div class=\"header__meta\">\n\t<div class=\"container\">\n\t\t<div class=\"header__meta__category\">\n\n\t\t\t\n\t\t\t\t\t\t\t<div class=\"header__meta__detail\">\n\t\t\t\t\t<div>Subject<\/div>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/fhi.nl\/en\/kennishub\/?_onderwerp_kennishub=implantaten-en-prothesen\" class=\"header__meta__detail--categorie\">\n\t\t\t\t\t\t\t\tImplants and prostheses\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/fhi.nl\/en\/kennishub\/?_onderwerp_kennishub=medische-technologie\" class=\"header__meta__detail--categorie\">\n\t\t\t\t\t\t\t\tMedical technology\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t<\/div>\n<\/div>\n\n<div class=\"text bg--white\">\n\t<div class=\"container\">\n\t\t\t\t\t\t\t\t\t\t\t<div class=\"text__content text__content--1-col\">\n\t\t\t<p><strong>The wish of a number of hospital umbrella organizations that Minister Bruno Bruins (Medical Care, VVD) imposes a reporting obligation on manufacturers of medical devices is unfeasible. This is what Luc Knaven, director of FHI Medical Technology, says in NRC.<\/strong><\/p>\r\n<p>According to Knaven, it is often not clear to manufacturers of medical devices how long they can continue to supply a product. According to Knaven, the biggest bottleneck lies with the European inspection bodies that have to certify the aids. He advocates more inspection bodies that can issue certificates. Currently, only nine of the 55 authorities are allowed to do this.<\/p>\r\n<p>Knaven is responding to a possible impending shortage of thousands of medical devices. This shortage is said to be caused by the fact that many medical products must comply with stricter European rules from May 26, while the current inspection capacity is said to be insufficient. This threatens to stall the certification process.<\/p>\r\n<p>Ad Melkert recently stated that Minister Bruins must intervene because patients are in danger of becoming victims. For example, some manufacturers are said to be withdrawing products from the market because they find the inspections too expensive. However, the minister is reluctant to introduce a reporting obligation, partly due to the fact that the medical device market is extremely diverse with hundreds of thousands of different products.<\/p>\r\n<p><a href=\"https:\/\/www.nrc.nl\/nieuws\/2020\/02\/10\/ziekenhuizen-vrezen-tekort-hulpmiddelen-a3989950\" target=\"_blank\" rel=\"noopener\">Read the entire article at NRC<\/a>.<\/p>\t\t<\/div>\n\t<\/div>\n<\/div>\r\n\t<div class=\"articles bg--offwhite automatic\">\r\n\t\t<div class=\"container\">\r\n\t\t\t<div class=\"articles__header\">\r\n\t\t\t\t\t\t\t\t\t<div class='heading-wrapper'><svg width=\"13\" height=\"13\" viewbox=\"0 0 13 13\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><circle cx=\"6.394\" cy=\"6.5\" r=\"6.394\" fill=\"#000\"\/><\/svg><h2>Related articles<\/h2><\/div>\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"\/en\/profiel\/fhi-federatie-van-technologie-branches\/\" class=\"button button--outline\">view profile<\/a>\r\n\t\t\t\t\t\t\t<\/div>\r\n\t\t\t\t\t\t<div class=\"post-grid post-grid--no-padding\">\r\n\t\t\t\t\n<a class=\"single-item single-item__articles\" href=\"https:\/\/fhi.nl\/en\/news\/making-and-evaluating-cross-sections\/\" data-id=\"38056\">\n\t<div class=\"single-item__articles-icon\">\n\t\t<svg width=\"103\" height=\"103\" viewbox=\"0 0 103 103\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n<path fill-rule=\"evenodd\" clip-rule=\"evenodd\" d=\"M49.5 98.9587V82.3076C33.3844 81.2758 20.6328 67.878 20.6328 51.5019C20.6328 35.1258 33.3844 21.728 49.5 20.6962V4.04134C24.1941 5.08952 4 25.9365 4 51.5C4 77.0635 24.1941 97.9105 49.5 98.9587ZM53.5 78.2983V61.8096H76.3238C72.5238 70.9498 63.8222 77.5397 53.5 78.2983ZM49.5 78.298V61.8096H26.681C30.4804 70.9484 39.1799 77.5377 49.5 78.298ZM47.0728 57.8096H25.3773C24.8906 55.7865 24.6328 53.6743 24.6328 51.5019C24.6328 37.3358 35.5955 25.7301 49.5 24.7058V37.013H34.0466C33.2709 37.013 32.5653 37.4615 32.2359 38.1637C31.9065 38.8659 32.0128 39.6952 32.5086 40.2916L47.0728 57.8096ZM55.9249 57.8096H77.6274C78.1141 55.7865 78.3719 53.6743 78.3719 51.5019C78.3719 37.3342 67.4068 25.7275 53.5 24.7055V37.013H68.9511C69.7268 37.013 70.4324 37.4615 70.7618 38.1637C71.0912 38.8659 70.9849 39.6952 70.4891 40.2916L55.9249 57.8096ZM53.5 82.3079V98.9587C78.8059 97.9105 99 77.0635 99 51.5C99 25.9365 78.8059 5.08952 53.5 4.04134V20.6959C69.6178 21.7254 82.3719 35.1242 82.3719 51.5019C82.3719 67.8796 69.6178 81.2784 53.5 82.3079ZM0 51.5C0 23.7271 21.9843 1.08883 49.5 0.0381213V0H51.5H53.5V0.0381213C81.0157 1.08883 103 23.7271 103 51.5C103 79.9427 79.9427 103 51.5 103C23.0573 103 0 79.9427 0 51.5ZM38.3102 41.013H64.6875L51.4989 56.8765L38.3102 41.013Z\" fill=\"#2DD881\"\/>\n<\/svg>\n\t<\/div>\n\t<div class=\"single-item__articles-title\"><div class='heading-wrapper'><h3>Making and Evaluating Cross Sections<\/h3><\/div><\/div>\n\t<div class=\"single-item__articles-terms\">\n\t\t\n\t\t\n\t\t\t\t\t\t<span class=\"button button--outline single-item__articles-term--branche single-item__articles-term\">Industrial Electronics<\/span>\n\t\t\t\t\t\t\t\t<span class=\"button button--outline single-item__articles-term--branche single-item__articles-term\">Design Automation &amp; 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