{"id":7756,"date":"2024-10-10T17:33:39","date_gmt":"2024-10-10T15:33:39","guid":{"rendered":"https:\/\/www.fnmotol.cz\/o-nas\/kvalita-a-bezpeci-zdravotnich-sluzeb\/vyroba-zdravotnickych-prostredku\/"},"modified":"2024-12-01T21:08:18","modified_gmt":"2024-12-01T20:08:18","slug":"vyroba-zdravotnickych-prostredku","status":"publish","type":"page","link":"https:\/\/www.fnmotol.cz\/en\/o-nas\/kvalita-a-bezpeci-zdravotnich-sluzeb\/vyroba-zdravotnickych-prostredku\/","title":{"rendered":"Manufacture of medical devices under Article 5(5) of EU Regulation 2017\/746 (IVDR)"},"content":{"rendered":"<!-- Text block H1 -->\n<div class=\"content\" data-aos=\"fade-up\">\n            <h1>Manufacture of medical devices under Article 5(5) of EU Regulation 2017\/746 (IVDR)<\/h1>\n            <\/div>\n<!-- \/Text block H1 -->\n\n <!-- Documents -->\n <div class=\"content\">\n                    <ul class=\"documents\">\n                                <!-- Document -->\n                    <li data-aos=\"fade-up\" data-aos-delay=\"50\">\n                        <span class=\"name\">Declaration of the medical facility <\/span>\n                        <div class=\"actions\">\n                            <a href=\"https:\/\/www.fnmotol.cz\/wp-content\/uploads\/2024\/10\/Prohlaseni-IVDR.pdf\" target=\"_blank\" class=\"show\">\n                                <svg width=\"20\" height=\"13\" viewBox=\"0 0 20 13\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n                                    <path d=\"M10.0046 10.1538C11.0287 10.1538 11.8976 9.79817 12.6114 9.08683C13.3253 8.37547 13.6822 7.51169 13.6822 6.49548C13.6822 5.47926 13.3237 4.61698 12.6069 3.90865C11.89 3.20032 11.0195 2.84615 9.99544 2.84615C8.97135 2.84615 8.10239 3.20182 7.38856 3.91317C6.67474 4.62452 6.31783 5.48831 6.31783 6.50453C6.31783 7.52074 6.67626 8.38302 7.39312 9.09135C8.10999 9.79968 8.98047 10.1538 10.0046 10.1538ZM10 9.2C9.24419 9.2 8.60174 8.9375 8.07267 8.4125C7.5436 7.8875 7.27907 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                            Zobrazit                            <\/a>\n                            <a href=\"https:\/\/www.fnmotol.cz\/wp-content\/uploads\/2024\/10\/Prohlaseni-IVDR.pdf\" target=\"_blank\" class=\"download\" download>\n                                <svg width=\"14\" height=\"14\" viewBox=\"0 0 14 14\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n                                    <path d=\"M7 10.5769L3.46152 7.03845L4.16923 6.31923L6.5 8.65V0H7.5V8.65L9.83078 6.31923L10.5385 7.03845L7 10.5769ZM1.61537 14C1.15512 14 0.770833 13.8458 0.4625 13.5375C0.154167 13.2292 0 12.8449 0 12.3846V9.96155H1V12.3846C1 12.5385 1.0641 12.6795 1.1923 12.8077C1.32052 12.9359 1.46154 13 1.61537 13H12.3846C12.5385 13 12.6795 12.9359 12.8077 12.8077C12.9359 12.6795 13 12.5385 13 12.3846V9.96155H14V12.3846C14 12.8449 13.8458 13.2292 13.5375 13.5375C13.2292 13.8458 12.8449 14 12.3846 14H1.61537Z\" fill=\"#002F4C\"\/>\n                                <\/svg>  \n                                    St\u00e1hnout                            <\/a>\n                        <\/div>\n                    <\/li>\n                                        <!-- Document -->\n                    <li data-aos=\"fade-up\" data-aos-delay=\"100\">\n                        <span class=\"name\">Annexes to the declaration<\/span>\n                        <div class=\"actions\">\n                            <a href=\"https:\/\/www.fnmotol.cz\/wp-content\/uploads\/2024\/10\/Prilohy-k-prohlaseni.pdf\" target=\"_blank\" class=\"show\">\n                                <svg width=\"20\" height=\"13\" viewBox=\"0 0 20 13\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n                                    <path d=\"M10.0046 10.1538C11.0287 10.1538 11.8976 9.79817 12.6114 9.08683C13.3253 8.37547 13.6822 7.51169 13.6822 6.49548C13.6822 5.47926 13.3237 4.61698 12.6069 3.90865C11.89 3.20032 11.0195 2.84615 9.99544 2.84615C8.97135 2.84615 8.10239 3.20182 7.38856 3.91317C6.67474 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4.77229 2.4875C3.18508 3.47917 1.97157 4.81667 1.13178 6.5C1.97157 8.18333 3.18508 9.52083 4.77229 10.5125C6.3595 11.5042 8.10207 12 10 12Z\" fill=\"#002F4C\"\/>\n                                <\/svg> \n                                Zobrazit                            <\/a>\n                            <a href=\"https:\/\/www.fnmotol.cz\/wp-content\/uploads\/2024\/10\/Prilohy-k-prohlaseni.pdf\" target=\"_blank\" class=\"download\" download>\n                                <svg width=\"14\" height=\"14\" viewBox=\"0 0 14 14\" fill=\"none\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n                                    <path d=\"M7 10.5769L3.46152 7.03845L4.16923 6.31923L6.5 8.65V0H7.5V8.65L9.83078 6.31923L10.5385 7.03845L7 10.5769ZM1.61537 14C1.15512 14 0.770833 13.8458 0.4625 13.5375C0.154167 13.2292 0 12.8449 0 12.3846V9.96155H1V12.3846C1 12.5385 1.0641 12.6795 1.1923 12.8077C1.32052 12.9359 1.46154 13 1.61537 13H12.3846C12.5385 13 12.6795 12.9359 12.8077 12.8077C12.9359 12.6795 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-->","protected":false},"excerpt":{"rendered":"","protected":false},"author":7,"featured_media":0,"parent":7750,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-7756","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Manufacture of medical devices under Article 5(5) of EU Regulation 2017\/746 (IVDR) - Fakultn\u00ed nemocnice Motol a Homolka<\/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.fnmotol.cz\/en\/o-nas\/kvalita-a-bezpeci-zdravotnich-sluzeb\/vyroba-zdravotnickych-prostredku\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" 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