{"id":345,"date":"2021-04-27T16:32:03","date_gmt":"2021-04-27T14:32:03","guid":{"rendered":"https:\/\/www.meliora-compliance.com\/?page_id=345"},"modified":"2023-09-25T16:51:29","modified_gmt":"2023-09-25T14:51:29","slug":"prrc-eu-mdr","status":"publish","type":"page","link":"https:\/\/www.meliora-compliance.com\/czech\/prrc-eu-mdr\/","title":{"rendered":"Osoba odpov\u011bdn\u00e1 za dodr\u017eov\u00e1n\u00ed pr\u00e1vn\u00edch p\u0159edpis\u016f (EU MDR)"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"345\" class=\"elementor elementor-345\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-1e75310c elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"1e75310c\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;shape_divider_bottom&quot;:&quot;triangle&quot;,&quot;shape_divider_bottom_negative&quot;:&quot;yes&quot;}\">\n\t\t\t\t\t<div class=\"elementor-shape elementor-shape-bottom\" data-negative=\"true\">\n\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 1000 100\" preserveaspectratio=\"none\">\n\t<path class=\"elementor-shape-fill\" d=\"M500.2,94.7L0,0v100h1000V0L500.2,94.7z\"\/>\n<\/svg>\t\t<\/div>\n\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-6ba8abbd\" data-id=\"6ba8abbd\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-20cf541d elementor-widget__width-initial elementor-widget-tablet__width-initial elementor-widget elementor-widget-image\" data-id=\"20cf541d\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"300\" height=\"300\" src=\"https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/08\/08_PRRC-300x300.png\" class=\"elementor-animation-push attachment-medium size-medium wp-image-822\" alt=\"\" srcset=\"https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/08\/08_PRRC-300x300.png 300w, https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/08\/08_PRRC-150x150.png 150w, https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/08\/08_PRRC-12x12.png 12w, https:\/\/www.meliora-compliance.com\/wp-content\/uploads\/2023\/08\/08_PRRC.png 512w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-4fa4dca2\" data-id=\"4fa4dca2\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e6bd163 elementor-widget__width-initial elementor-widget elementor-widget-heading\" data-id=\"e6bd163\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Osoba odpov\u011bdn\u00e1 za dodr\u017eov\u00e1n\u00ed pr\u00e1vn\u00edch p\u0159edpis\u016f (EU MDR)<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7bf63d70 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7bf63d70\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4dd4295b\" data-id=\"4dd4295b\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5346b31f elementor-widget elementor-widget-heading\" data-id=\"5346b31f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Pro\u010d PRRC?<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3988d641 elementor-widget elementor-widget-text-editor\" data-id=\"3988d641\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">Evropsk\u00e1 na\u0159\u00edzen\u00ed MDR (2017\/745) a IVDR (2017\/746) vy\u017eaduj\u00ed, aby v\u00fdrobci (manufacturers), zplnomocn\u011bn\u00ed z\u00e1stupci (authorised representatives) a jin\u00e9 hospod\u00e1\u0159sk\u00e9 subjekty (economic operators), pokud se na n\u011b vztahuj\u00ed povinnosti v\u00fdrobce, zplnomocnili Osobu odpov\u011bdnou za dodr\u017eov\u00e1n\u00ed pr\u00e1vn\u00edch p\u0159edpis\u016f, anglicky Person Responsible for Regulatory Compliance (PRRC).<\/span><\/p><p><span style=\"font-weight: 400;\">Pokud je va\u0161e firma klasifikov\u00e1na jako mikropodnik nebo mal\u00fd podnik, Meliora Compliance v\u00e1m nab\u00edz\u00ed slu\u017eby jako va\u0161e extern\u00ed PRRC.<\/span><\/p><p><span style=\"font-weight: 400;\">PRRC responsibilities:<\/span><\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-48c412e0 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"48c412e0\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-666c3d3f\" data-id=\"666c3d3f\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-21ec7c43 elementor-widget elementor-widget-text-editor\" data-id=\"21ec7c43\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Shoda prost\u0159edk\u016f je p\u0159ed uvoln\u011bn\u00edm prost\u0159edku n\u00e1le\u017eit\u011b kontrolov\u00e1na v souladu se syst\u00e9mem \u0159\u00edzen\u00ed kvality, v jeho\u017e r\u00e1mci je tento prost\u0159edek vyroben;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Je vypracov\u00e1na a pravideln\u011b aktualizov\u00e1na technick\u00e1 dokumentace a EU prohl\u00e1\u0161en\u00ed o shod\u011b;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Jsou spln\u011bny povinnosti t\u00fdkaj\u00edc\u00ed se sledov\u00e1n\u00ed po uveden\u00ed na trh;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Jsou spln\u011bny ohla\u0161ovac\u00ed povinnosti;<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">V p\u0159\u00edpad\u011b prost\u0159edk\u016f, kter\u00e9 jsou p\u0159edm\u011btem klinick\u00e9 zkou\u0161ky, vyd\u00e1v\u00e1 prohl\u00e1\u0161en\u00ed o tom, \u017ee dan\u00fd prost\u0159edek je ve shod\u011b s obecn\u00fdmi po\u017eadavky na bezpe\u010dnost a \u00fa\u010dinnost, a \u017ee byla p\u0159ijata v\u0161echna p\u0159edb\u011b\u017en\u00e1 opat\u0159en\u00ed k ochran\u011b zdrav\u00ed a bezpe\u010dnosti subjektu.<\/span><\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2da60a0e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2da60a0e\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-231ce82d\" data-id=\"231ce82d\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-741a52d4 elementor-widget elementor-widget-heading\" data-id=\"741a52d4\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-medium\">Dotazy?<br>\nNapi\u0161te n\u00e1m!<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-131b497a elementor-align-center elementor-widget elementor-widget-button\" data-id=\"131b497a\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-md\" href=\"https:\/\/www.meliora-compliance.com\/czech\/contact-us\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon elementor-align-icon-right\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"fas fa-long-arrow-alt-right\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t<span class=\"elementor-button-text\">Kontakt<\/span>\n\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>PRRC (EU MDR) Why PRRC? The European MDR (2017\/745) and IVDR (2017\/746) require that manufacturers, authorised representatives and other economic operators, if the obligations of the manufacturer apply to them, shall have a person that will be responsible for regulatory compliance (PRRC). If your establishment is classified as a micro or a small enterprise, Meliora &#8230; <a title=\"Osoba odpov\u011bdn\u00e1 za dodr\u017eov\u00e1n\u00ed pr\u00e1vn\u00edch p\u0159edpis\u016f (EU MDR)\" class=\"read-more\" href=\"https:\/\/www.meliora-compliance.com\/czech\/prrc-eu-mdr\/\" aria-label=\"V\u00edce na PRRC (EU MDR)\">\u010c\u00edst d\u00e1l<\/a><\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-345","page","type-page","status-publish"],"_links":{"self":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages\/345","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/comments?post=345"}],"version-history":[{"count":58,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages\/345\/revisions"}],"predecessor-version":[{"id":1493,"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/pages\/345\/revisions\/1493"}],"wp:attachment":[{"href":"https:\/\/www.meliora-compliance.com\/czech\/wp-json\/wp\/v2\/media?parent=345"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}