{"id":13291,"date":"2023-05-26T11:27:23","date_gmt":"2023-05-26T08:27:23","guid":{"rendered":"https:\/\/medfilesgroup.com\/?p=13291"},"modified":"2026-05-20T14:23:32","modified_gmt":"2026-05-20T11:23:32","slug":"mdr-asetus-hyva-kliininen-kaytanto","status":"publish","type":"post","link":"https:\/\/medfilesgroup.com\/fi\/mdr-asetus-hyva-kliininen-kaytanto\/","title":{"rendered":"Maksuton opas: Miten MDR-asetuksen edellytt\u00e4m\u00e4 hyv\u00e4 kliininen k\u00e4yt\u00e4nt\u00f6 toteutetaan?"},"content":{"rendered":"\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-vertically-aligned-center is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:55%\">\n<p>L\u00e4\u00e4kinn\u00e4llisi\u00e4 laitteita koskevan asetuksen eli MDR-asetuksen (2017\/745) mukaan kliiniset tutkimukset on suoritettava hyv\u00e4n kliinisen k\u00e4yt\u00e4nn\u00f6n mukaisesti (ISO 14155:2020 Clinical investigation of medical devices for human subjects \u2013 Good clinical practice). Tutkimusten toimeksiantajien onkin noudatettava MDR-asetuksen vaatimuksia ja lis\u00e4ksi tunnettava hyvin my\u00f6s ISO-standardin vaatimukset.<\/p>\n\n\n\n<p>Medfiles on laatinut hyv\u00e4n kliinisen k\u00e4yt\u00e4nn\u00f6n oppaan asioista, joita toimeksiantajien olisi hyv\u00e4 tiet\u00e4\u00e4 tutkimuksen valmistelusta, monitoroinnista ja p\u00e4\u00e4tt\u00e4misest\u00e4. Oppaassa korostetaan etenkin niit\u00e4 seikkoja, jotka kokemuksemme mukaan saattavat tuntua vaikeaselkoisilta tutkimuksen toimeksiantajan n\u00e4k\u00f6kulmasta. Opas on englanninkielinen.<\/p>\n\n\n\n<div style=\"height:11px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" href=\"https:\/\/medfiles.activehosted.com\/f\/1\" style=\"font-size:15px\" rel=\"noopener\">Lataa maksuton opas<\/a><\/div>\n\n\n\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" href=\"https:\/\/medfilesgroup.com\/fi\/palvelut\/palvelut-laakinnallisille-laitteille-ja-ivd-laitteille\/kliiniset-tutkimukset\/\" style=\"font-size:15px\">Kliiniset tutkimuspalvelut<\/a><\/div>\n\n\n\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-custom-font-size wp-element-button\" href=\"https:\/\/medfilesgroup.com\/fi\/yhteystiedot\/tilaa-medfilesin-uutiskirje\/\" style=\"font-size:15px\">Tilaa uutiskirje<\/a><\/div>\n<\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-vertically-aligned-top is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:45%\">\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"1080\" height=\"1080\" src=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/05\/mdr-good-clinical-practice-requirements.jpg\" alt=\"MDR Good Clinical Practice requirements\" class=\"wp-image-13284\" srcset=\"https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/05\/mdr-good-clinical-practice-requirements.jpg 1080w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/05\/mdr-good-clinical-practice-requirements-300x300.jpg 300w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/05\/mdr-good-clinical-practice-requirements-1024x1024.jpg 1024w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/05\/mdr-good-clinical-practice-requirements-150x150.jpg 150w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/05\/mdr-good-clinical-practice-requirements-768x768.jpg 768w, https:\/\/medfilesgroup.com\/wp-content\/uploads\/2023\/05\/mdr-good-clinical-practice-requirements-360x360.jpg 360w\" sizes=\"auto, (max-width: 1080px) 100vw, 1080px\" \/><\/figure>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>L\u00e4\u00e4kinn\u00e4llisi\u00e4 laitteita koskevan asetuksen eli MDR-asetuksen (2017\/745) mukaan kliiniset tutkimukset on suoritettava hyv\u00e4n kliinisen k\u00e4yt\u00e4nn\u00f6n mukaisesti (ISO 14155:2020 Clinical investigation of medical devices for human &#8230; <a title=\"Maksuton opas: Miten MDR-asetuksen edellytt\u00e4m\u00e4 hyv\u00e4 kliininen k\u00e4yt\u00e4nt\u00f6 toteutetaan?\" class=\"read-more\" href=\"https:\/\/medfilesgroup.com\/fi\/mdr-asetus-hyva-kliininen-kaytanto\/\" aria-label=\"Lis\u00e4\u00e4 Maksuton opas: Miten MDR-asetuksen edellytt\u00e4m\u00e4 hyv\u00e4 kliininen k\u00e4yt\u00e4nt\u00f6 toteutetaan?\">Lue lis\u00e4\u00e4<\/a><\/p>\n","protected":false},"author":10,"featured_media":13284,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9],"tags":[],"product":[385],"content_type":[387],"service":[398,399],"class_list":["post-13291","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uutiset","product-laakinnalliset-laitteet-ja-ivd-laitteet","content_type-blogit","service-laakinnallisten-ja-ivd-laitteiden-lainsaadanto","service-laakinnallisten-ja-ivd-laitteiden-kliiniset-arvioinnit-ja-tutkimukset"],"_links":{"self":[{"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/posts\/13291","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/users\/10"}],"replies":[{"embeddable":true,"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/comments?post=13291"}],"version-history":[{"count":5,"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/posts\/13291\/revisions"}],"predecessor-version":[{"id":22887,"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/posts\/13291\/revisions\/22887"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/media\/13284"}],"wp:attachment":[{"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/media?parent=13291"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/categories?post=13291"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/tags?post=13291"},{"taxonomy":"product","embeddable":true,"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/product?post=13291"},{"taxonomy":"content_type","embeddable":true,"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/content_type?post=13291"},{"taxonomy":"service","embeddable":true,"href":"https:\/\/medfilesgroup.com\/fi\/wp-json\/wp\/v2\/service?post=13291"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}