{"id":1124,"date":"2022-01-19T12:34:04","date_gmt":"2022-01-19T10:34:04","guid":{"rendered":"https:\/\/lymed.fi\/en\/?page_id=1124"},"modified":"2026-03-20T14:23:31","modified_gmt":"2026-03-20T12:23:31","slug":"mdr","status":"publish","type":"page","link":"https:\/\/lymed.fi\/en\/lymed-products\/mdr\/","title":{"rendered":"MDR"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; next_background_color=&#8221;#ffffff&#8221; _builder_version=&#8221;4.17.3&#8243; _module_preset=&#8221;default&#8221; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_stops=&#8221;#145b42 0%|#145b42 100%&#8221; background_color_gradient_start=&#8221;#145b42&#8243; background_color_gradient_end=&#8221;#145b42&#8243; background_image=&#8221;https:\/\/lymed.fi\/en\/wp-content\/uploads\/2022\/03\/tuotteet_tausta3.jpg&#8221; background_position=&#8221;bottom_center&#8221; background_blend=&#8221;overlay&#8221; top_divider_height_tablet=&#8221;&#8221; top_divider_height_phone=&#8221;&#8221; 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\/*change arrow icon for submenu*\/<!-- [et_pb_line_break_holder] -->  right: 20px !important;<!-- [et_pb_line_break_holder] -->  top: 10px;<!-- [et_pb_line_break_holder] -->  }<!-- [et_pb_line_break_holder] -->.et-vert-menu .nav li ul {<!-- [et_pb_line_break_holder] -->    left: calc(100% - 1px) !important; \/*align submenu to the right of menu link*\/<!-- [et_pb_line_break_holder] -->  }<!-- [et_pb_line_break_holder] -->@media all and (min-width: 981px) {<!-- [et_pb_line_break_holder] -->.et-vert-menu .et_pb_menu__menu, .et-vert-menu .et_pb_menu__menu>nav {<!-- [et_pb_line_break_holder] -->    width: 100%; \/*width of the vertical navigation menu*\/<!-- [et_pb_line_break_holder] -->  }<!-- [et_pb_line_break_holder] -->}<!-- [et_pb_line_break_holder] -->}<!-- [et_pb_line_break_holder] --><\/style>\n<p>[\/et_pb_code][\/et_pb_column][et_pb_column type=&#8221;2_3&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.27.5&#8243; _module_preset=&#8221;740e7acb-8ccd-44e0-ad57-d6f21a25e446&#8243; text_font=&#8221;Open Sans||||||||&#8221; header_4_font=&#8221;Work Sans||||||||&#8221; header_4_line_height=&#8221;1.5em&#8221; hover_enabled=&#8221;0&#8243; text_font_size_tablet=&#8221;&#8221; text_font_size_phone=&#8221;&#8221; text_font_size_last_edited=&#8221;on|desktop&#8221; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<div class=\"col-sm-12 col-md-9\">\n<h2 class=\"title\">Medical Device Regulation (EU) 2017\/745<\/h2>\n<blockquote><\/blockquote>\n<div class=\"x_elementToProof\"><b data-olk-copy-source=\"MessageBody\">Compliance with Medical Device Regulations<\/b><\/div>\n<div class=\"x_elementToProof\"><b data-olk-copy-source=\"MessageBody\"><\/b><\/div>\n<div class=\"x_elementToProof\"><\/div>\n<div class=\"x_elementToProof\"><em><b>Lymed products comply with the requirements of the EU Medical Device Regulation (EU) 2017\/745 (MDR). Our product range also includes wellness products that are not classified as medical devices.<\/b><\/em><\/div>\n<div class=\"x_elementToProof\"><em><b><\/b><\/em><\/div>\n<div class=\"x_elementToProof\"><em><b><\/b><\/em><\/div>\n<div class=\"x_elementToProof\">\n<div class=\"x_elementToProof\"><b>Standard Products<\/b><\/div>\n<ul data-end=\"413\" data-start=\"326\">\n<li>\n<div class=\"x_elementToProof\" role=\"presentation\">CE-marked Class I medical devices<\/div>\n<\/li>\n<li>\n<div class=\"x_elementToProof\" role=\"presentation\">designed for general use with standard sizing<\/div>\n<\/li>\n<\/ul>\n<div class=\"x_elementToProof\"><b>Custom-Made Products<\/b><\/div>\n<ul data-end=\"676\" data-start=\"440\">\n<li>\n<div class=\"x_elementToProof\" role=\"presentation\">Class I custom-made medical devices<\/div>\n<\/li>\n<li>\n<div class=\"x_elementToProof\" role=\"presentation\">designed and manufactured based on the user\u2019s individual measurements and needs<\/div>\n<\/li>\n<li>\n<div class=\"x_elementToProof\" role=\"presentation\">manufactured, where applicable, in accordance with the guidance or prescription of a healthcare professional<\/div>\n<\/li>\n<\/ul>\n<\/div>\n<div class=\"x_elementToProof\"><b>In Finland, medical devices are supervised by Fimea (Finnish Medicines Agency).<\/b><\/div>\n<\/div>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p><span><span><a href=\"https:\/\/lymed.fi\/en\/\">Lymed<\/a><\/span><\/span> Medical Device Regulation (EU) 2017\/745 Compliance with Medical Device Regulations Lymed products comply with the requirements of the EU Medical Device Regulation (EU) 2017\/745 (MDR). Our product range also includes wellness products that are not classified as medical devices. Standard Products CE-marked Class I medical devices designed for general use with standard sizing Custom-Made [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":1743,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"class_list":["post-1124","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>MDR - Lymed<\/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:\/\/lymed.fi\/en\/lymed-products\/mdr\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MDR - Lymed\" \/>\n<meta property=\"og:description\" content=\"Medical Device Regulation (EU) 2017\/745 Compliance with Medical Device Regulations Lymed products comply with the requirements of the EU Medical Device Regulation (EU) 2017\/745 (MDR). 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