{"id":51,"date":"2023-07-28T12:53:17","date_gmt":"2023-07-28T03:53:17","guid":{"rendered":"https:\/\/ce-certi.or.kr\/?page_id=51"},"modified":"2026-04-13T16:03:30","modified_gmt":"2026-04-13T07:03:30","slug":"ce-ivdr","status":"publish","type":"page","link":"https:\/\/ce-certi.or.kr\/?page_id=51","title":{"rendered":"CE-IVDR"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"51\" class=\"elementor elementor-51\">\n\t\t\t\t<div class=\"elementor-element elementor-element-cfe896b e-flex e-con-boxed e-con e-parent\" data-id=\"cfe896b\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7f649fc elementor-widget elementor-widget-text-editor\" data-id=\"7f649fc\" 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\t\t<p class=\"has-vivid-red-color has-text-color\" style=\"font-family: Tahoma, sans-serif; font-size: 25px; padding-left: 40px;\"><span style=\"font-weight: bold;\">CE-IVDR<\/span><\/p><p style=\"color: #6d6d6d; font-family: Tahoma, sans-serif; font-size: 18px; padding-left: 40px;\"><span style=\"font-weight: bold;\">\uccb4\uc678\uc9c4\ub2e8\uc758\ub8cc\uae30\uae30<\/span>\u00a0_<span style=\"font-weight: bold;\">IVDR (In Vitro Diagnostic Medical Devices Regulation)<\/span><\/p><h2 style=\"font-family: Tahoma, sans-serif; font-size: 25px; text-transform: uppercase; padding-left: 40px;\"><span style=\"color: #003300;\">\ub3c4\uc785\uc2dc\uae30<\/span><\/h2><p style=\"padding-left: 40px; color: #606060; font-family: 'Open Sans', 'Helvetica Neue', helvetica, arial, sans-serif; font-size: 16px;\">\uc758\ub8cc\uae30\uae30\uc5d0 \uad00\ud55c EU \uaddc\uc815(MDR: Medical Device Regulation)\uacfc \ubd80\ud569\ud558\uc5ec, \uc720\ub7fd \uc758\ud68c\uc640 \uc704\uc6d0\ud68c\uc758 \uccb4\uc678\uc9c4\ub2e8\uc758\ub8cc\uae30\uae30 \uaddc\uc815<br \/>2017\/746(IVDR: In Vitro Diagnostic Regulation)\uc774 2017\ub144 5\uc6d4 26\uc77c\uc5d0 \ubc1c\ud6a8\ub418\uc5c8\uc73c\uba70,\u00a0<span style=\"font-weight: 600;\">2022\ub144 5\uc6d4 26\uc77c\ubd80\ud130 \uc801\uc6a9\uc774 \uac1c\uc2dc<\/span>\ub418\uc5c8\uc2b5\ub2c8\ub2e4.<\/p><p style=\"padding-bottom: 1.563rem; padding-left: 40px; color: #606060; font-family: 'Open Sans', 'Helvetica Neue', helvetica, arial, sans-serif; font-size: 16px;\">\uad6c\ubc95\uc778 IVDD(\uc9c0\uce68, Directive)\uc5d0\uc11c IVDR(\uaddc\uc815, Regulation)\uc73c\ub85c \uc0c1\ud5a5\ub418\uc5c8\uc73c\uba70, IVDR\uc740 \uccb4\uc678\uc9c4\ub2e8\uc6a9 \uc758\ub8cc\uae30\uae30\uc5d0 \ub300\ud55c EU\uc758<br \/>\ud604\ud589 \uc9c0\uce68 IVDD(98\/79\/EC)\ub97c \ub300\uccb4\ud558\uc5ec \uc720\ub7fd\uc5d0 \uc720\ud1b5\ub418\ub294 \ubaa8\ub4e0 \uc81c\ud488\uc774 \ub300\uc0c1\uc774 \ub429\ub2c8\ub2e4.<\/p><h2 style=\"font-family: Tahoma, sans-serif; font-size: 25px; text-transform: uppercase; padding-left: 40px;\"><span style=\"color: #003300;\">\uc801\uc6a9\ub300\uc0c1\ud488\ubaa9<\/span><\/h2><p style=\"padding-left: 40px; color: #606060; font-family: 'Open Sans', 'Helvetica Neue', helvetica, arial, sans-serif; font-size: 16px;\">\uac00\uc7a5 \ud070 \ubcc0\ud654\ub294 \uccb4\uc678\uc9c4\ub2e8\uc758\ub8cc\uae30\uae30(In Vitro Diagnostics, IVD)\uac00 \uae30\uc874 \ub4f1\uae09 \ubd84\ub958 \uccb4\uacc4\uc5d0\uc11c \uc704\ud5d8\ub3c4\uac00 \ub0ae\uc740 A\ub4f1\uae09\uc5d0\uc11c<br \/>\uace0\uc704\ud5d8\uc778 D\ub4f1\uae09\uae4c\uc9c0 4\ub4f1\uae09\uc758 \ubd84\ub958 \uccb4\uacc4\ub85c \ubcc0\uacbd\ub418\ub294 \uac83\uc785\ub2c8\ub2e4.<\/p><ul style=\"margin-bottom: 1.6rem; color: #606060; font-family: 'Open Sans', 'Helvetica Neue', helvetica, arial, sans-serif; font-size: 16px;\"><li style=\"list-style-type: none;\"><ul><li><span style=\"font-weight: 600;\">A\ub4f1\uae09:<\/span>\u00a0\uac1c\uc778\uacfc \uacf5\uc911\ubcf4\uac74\uc5d0 \ub0ae\uc740 \uc704\ud5d8\ub3c4. \uc608) \uc561\uc138\uc11c\ub9ac, \uc138\ucc99\uc561, \uc7a5\ube44 \ub4f1<\/li><li><span style=\"font-weight: 600;\">B\ub4f1\uae09:<\/span>\u00a0\ubcf4\ud1b5\uc5d0\uc11c \ub0ae\uc740 \uac1c\uc778\uc758 \uc704\ud5d8\ub3c4\uc640 \ub0ae\uc740 \uacf5\uc911\ubcf4\uac74\uc758 \uc704\ud5d8\ub3c4. \uc608) \uac11\uc0c1\uc120 \uae30\ub2a5 \uac80\uc0ac\uae30, \ubd88\uc784 \uac80\uc0ac\uae30, \uc790\uac00 \uce21\uc815\uae30\uae30(\ucf5c\ub808\uc2a4\ud14c\ub864, \uc18c\ubcc0\uc9c4\ub2e8\uae30 \ub4f1)<\/li><li><span style=\"font-weight: 600;\">C\ub4f1\uae09:<\/span>\u00a0\uac1c\uc778\uc5d0\uac8c \uace0\uc704\ud5d8\ub3c4\uc640 \ubcf4\ud1b5\uc5d0\uc11c \ub0ae\uc740 \uacf5\uc911\ubcf4\uac74\uc758 \uc704\ud5d8\ub3c4. \uc608) \uc720\uc804\uc790 \uac80\uc0ac, \ud608\ub2f9\uce21\uc815\uae30\uae30, \ub3d9\ubc18\uc9c4\ub2e8\uae30\uae30<\/li><li><span style=\"font-weight: 600;\">D\ub4f1\uae09:<\/span>\u00a0\uac1c\uc778 \ubc0f \uacf5\uc911\ubcf4\uac74\uc5d0 \uace0\uc704\ud5d8. \uc608) HIV 1\/2 \uac80\uc0ac\uae30\uae30, \ud608\uc561\uac80\uc0ac\uae30\uae30, \ub9e4\ub3c5\uac80\uc0ac\uae30\uae30<\/li><\/ul><\/li><\/ul><h2 style=\"font-family: Tahoma, sans-serif; font-size: 25px; text-transform: uppercase; padding-left: 40px;\"><span style=\"color: #003300;\">MDR \uc8fc\uc694 \ubcc0\uacbd\uc0ac\ud56d<\/span><\/h2><p style=\"padding-left: 40px; color: #606060; font-family: 'Open Sans', 'Helvetica Neue', helvetica, arial, sans-serif; font-size: 16px;\"><span style=\"color: #000000;\"><span style=\"font-weight: 600;\">1. \uc0ac\uc804 \uc2b9\uc778\uc5d0\uc11c \uc548\uc804\uc131\uc744 \uac15\ud654\ud55c \uc804\uc8fc\uae30 \uad00\ub9ac \uce21\uba74\uc73c\ub85c\uc758 \uc804\ud658<\/span><\/span><\/p><ul style=\"color: #606060; font-family: 'Open Sans', 'Helvetica Neue', helvetica, arial, sans-serif; font-size: 16px;\"><li style=\"list-style-type: none;\"><ul><li>\uc81c\uc870\uc5c5\uc790\uc640 \uc81c\ud488 \uc0dd\uc0b0 \uc815\ubcf4\ub97c \uc6a9\uc774\ud558\uac8c \uc2dd\ubcc4\ud560 \uc218 \uc788\ub294 UDI(Unique Device Identifier) \ub3c4\uc785<\/li><li>MDR\uacfc \ub3d9\uc77c\ud558\uac8c \uaddc\uc815 \uc900\uc218 \ucc45\uc784\uc790(Person Responsible for Regulatory Compliance) 1\uba85 \uc774\uc0c1 \uc9c0\uc815 \uc694\uad6c<\/li><li>\ud488\uc9c8\uad00\ub9ac\uc2dc\uc2a4\ud15c(QMS)\uacfc \uc2dc\ud310 \ud6c4 \uac10\uc2dc \uc2dc\uc2a4\ud15c\uc744 \ub3c4\uc785\ud558\uc5ec \uc81c\ud488\uc758 \uc9c0\uc18d\uc801\uc778 \uc801\ud569\uc131 \uc720\uc9c0 \ubcf4\uc7a5<\/li><\/ul><\/li><\/ul><div style=\"color: #606060; font-family: 'Open Sans', 'Helvetica Neue', helvetica, arial, sans-serif; font-size: 16px;\"><p style=\"padding-left: 40px;\"><span style=\"color: #000000;\"><span style=\"font-weight: 600;\">2. \uc784\uc0c1\uc5f0\uad6c \ubc0f \ud3c9\uac00\uc5d0 \ub300\ud55c \uac15\uc870<\/span><\/span><\/p><ul><li style=\"list-style-type: none;\"><ul><li>\uc784\uc0c1\uc5f0\uad6c\ub97c \ud1b5\ud55c \ub370\uc774\ud130 \ucd5c\uc2e0\ud654, \uae30\uc220 \ubb38\uc11c\uc640 \ub77c\ubca8\ub9c1 \uac15\ud654<\/li><li>\uc81c\uc870\uc5c5\uccb4\ub85c \ud558\uc5ec\uae08 \uc548\uc804 \ubc0f \uc131\ub298 \uc778\uc99d\uc744 \uc704\ud574 \uad6c\uccb4\uc801\uc778 \uc815\ubcf4\ub97c \uc694\uad6c\ud560 \ubfd0\ub9cc \uc544\ub2c8\ub77c \ud22c\uba85\uc131 \uac15\ud654\ub97c \uc704\ud574 EUDAMED \ub0b4 \ub4f1\ub85d \ubc0f \uad00\ub9ac \uc694\uad6c<br \/>\u2013 2026\ub144 5\uc6d4 28\uc77c\ubd80\ud130 4\uac1c \ubaa8\ub4c8 \uc758\ubb34 \uc0ac\uc6a9 \uac1c\uc2dc<\/li><li>\uc2dc\ud310 \ud6c4 \uc131\ub2a5 \ud6c4\uc18d \uc870\uce58(PMPF, Post-Market Performance Follow-up) \uc2dc\ud589 \uc758\ubb34\ud654, Class C\/D \uc81c\ud488\uc5d0 \ub300\ud574<br \/>\uc8fc\uae30\uc801\uc778 \uc548\uc804\uc131 \uac31\uc2e0 \ubcf4\uace0\uc11c(PSUR) \uc791\uc131<\/li><\/ul><\/li><\/ul><div><p style=\"padding-left: 40px;\"><span style=\"color: #000000;\"><span style=\"font-weight: 600;\">3. \uc778\uc99d\uae30\uad00(Notified Body)\uc5d0 \ub300\ud55c \uac15\ub825\ud55c \uac10\ub3c5<\/span><\/span><\/p><ul><li style=\"list-style-type: none;\"><ul><li>\uc778\uc99d\uae30\uad00 \uc9c0\uc815 \ubc0f \ubaa8\ub2c8\ud130\ub9c1\uc5d0 \uc788\uc5b4 \ubcf4\ub2e4 \uc5c4\uaca9\ud55c \uae30\uc900\uc774 \uc801\uc6a9\ub428\uc5d0 \ub530\ub77c \uc801\ud569\uc131 \ud3c9\uac00 \uc808\ucc28 \ubc0f \uc2b9\uc778 \uc7a5\uae30\ud654. \ud604\uc7ac IVDR \uae30\uc900 \uc9c0\uc815\ub41c<br \/>\uc778\uc99d\uae30\uad00\uc740 19\uac1c\ub85c \uc810\uc9c4\uc801\uc73c\ub85c \ud655\ub300 \uc911<\/li><\/ul><\/li><\/ul><p style=\"padding-left: 40px;\"><span style=\"color: #000000;\"><span style=\"font-weight: 600;\">4. EU \ucc38\uc870\uc2e4\ud5d8\uc2e4(EURL) \uc2e0\uc124 \u2015 IVDR \uace0\uc720 \uc694\uad6c\uc0ac\ud56d<\/span><\/span><\/p><ul style=\"margin-bottom: 1.6rem;\"><li style=\"list-style-type: none;\"><ul><li>IVDR\uc740 MDR\uc5d0\ub294 \uc5c6\ub294\u00a0<span style=\"font-weight: 600;\">EU \ucc38\uc870\uc2e4\ud5d8\uc2e4(EURL, EU Reference Laboratory)<\/span>\u00a0\uc81c\ub3c4\ub97c \ub3c4\uc785\ud558\uc600\uc2b5\ub2c8\ub2e4. Class D \uace0\uc704\ud5d8 \uc81c\ud488\uc740<br \/>\uc778\uc99d\uae30\uad00(Notified Body)\uc758 \uc801\ud569\uc131 \ud3c9\uac00 \uc678\uc5d0\u00a0<span style=\"font-weight: 600;\">EURL\uc758 \ub3c5\ub9bd\uc801 \uac80\uc99d\uc744 \ucd94\uac00\ub85c \uac70\uccd0\uc57c<\/span>\u00a0\ud558\uba70, \uc774\ub294 \ud608\uc561\u00b7\uc7a5\uae30 \uae30\uc99d \uad00\ub828 \uac10\uc5fc \uac80\uc0ac \ub4f1<br \/>\uacf5\uc911\ubcf4\uac74\uc5d0 \ubbf8\uce58\ub294 \uc601\ud5a5\uc774 \ud070 \uc81c\ud488\uc758 \uc548\uc804\uc131\uc744 \ud655\ubcf4\ud558\uae30 \uc704\ud55c \uc870\uce58\uc785\ub2c8\ub2e4.<\/li><li>2024\ub144 10\uc6d4\ubd80\ud130 \uac04\uc5fc\/\ub808\ud2b8\ub85c\ubc14\uc774\ub7ec\uc2a4, \ud638\ud761\uae30 \ubc14\uc774\ub7ec\uc2a4 \uce74\ud14c\uace0\ub9ac\uc758 EURL\uc774 \uc6b4\uc601\uc744 \uc2dc\uc791\ud558\uc600\uc73c\uba70,<br \/><span style=\"font-weight: 600;\">2026\ub144 5\uc6d4\ubd80\ud130 \uae30\uc0dd\ucda9(Parasites) \ubc0f \ud608\uc561\ud615 \ub9c8\ucee4(Blood group markers) \uce74\ud14c\uace0\ub9ac\uac00 \ucd94\uac00<\/span>\ub85c \uc6b4\uc601\ub420 \uc608\uc815\uc785\ub2c8\ub2e4.<\/li><li>EURL \uac80\uc99d \uc808\ucc28\ub294 \uc778\uc99d \uc18c\uc694 \uae30\uac04\uacfc \ube44\uc6a9\uc744 \ucd94\uac00\ub85c \ubc1c\uc0dd\uc2dc\ud0a4\ubbc0\ub85c, Class D \uc81c\ud488 \uc81c\uc870\uc5c5\uccb4\ub294 \uc778\uc99d \uc77c\uc815 \uc218\ub9bd \uc2dc<br \/>\ubc18\ub4dc\uc2dc EURL \uc808\ucc28\ub97c \ud3ec\ud568\ud558\uc5ec \uacc4\ud68d\ud574\uc57c \ud569\ub2c8\ub2e4.\\<\/li><\/ul><\/li><\/ul><\/div><\/div><h2 style=\"font-family: Tahoma, sans-serif; font-size: 25px; text-transform: uppercase; padding-left: 40px;\"><span style=\"color: #003300;\">IVDR \uc804\ud658\uae30\uac04 \ud604\ud669(2026\ub144 \uae30\uc900)<\/span><\/h2><div style=\"color: #606060; font-family: 'Open Sans', 'Helvetica Neue', helvetica, arial, sans-serif; font-size: 16px;\"><div>\u00a0<\/div><ul style=\"margin-bottom: 1.6rem;\"><li style=\"list-style-type: none;\"><ul style=\"margin-bottom: 1.6rem;\"><li style=\"list-style-type: none;\">\u00a0Regulation (EU) 2024\/1860(2024\ub144 7\uc6d4 9\uc77c \ubc1c\ud6a8)\uc5d0 \uc758\ud574 \ucd5c\uc885 \ud655\uc815\ub418\uc5c8\uc73c\uba70, \ub4f1\uae09 \ubc0f \uae30\uc874 IVDD \uc778\uc99d \ubcf4\uc720 \uc5ec\ubd80\uc5d0 \ub530\ub77c \uc544\ub798\uc640 \uac19\uc774 \uc801\uc6a9\ub429\ub2c8\ub2e4.<br \/><span style=\"font-weight: 600;\"><br \/><\/span><\/li><li style=\"list-style-type: none;\"><span style=\"font-weight: 600;\"><span style=\"color: #000000;\">\u2460 \uae30\uc874 IVDD \uc778\uc99d\uc11c \ubcf4\uc720 \uc81c\ud488 (Legacy Device)<\/span><br \/><img fetchpriority=\"high\" decoding=\"async\" src=\"https:\/\/fda-certi.org\/wp-content\/uploads\/2026\/04\/%EA%B7%B8%EB%A6%BC6-scaled.png\" alt=\"\" width=\"900\" height=\"192\" \/><br \/><\/span><\/li><li style=\"list-style-type: none;\"><span style=\"font-weight: bold;\"><span style=\"color: #000000;\">\u2461 \uae30\uc874 IVDD \uc778\uc99d \uc5c6\uc774 \uc790\uccb4\uc120\uc5b8(Self-declared)\uc73c\ub85c \uc720\ud1b5\ub418\ub358 \uc81c\ud488<\/span><br \/><img decoding=\"async\" src=\"https:\/\/fda-certi.org\/wp-content\/uploads\/2026\/04\/%EA%B7%B8%EB%A6%BC7.png\" alt=\"\" width=\"650\" height=\"193\" \/><\/span><\/li><li style=\"list-style-type: none;\">\uc804\ud658\uae30\uac04 \uc801\uc6a9\uc744 \uc704\ud574\uc11c\ub294 2025\ub144 5\uc6d4 26\uc77c\uae4c\uc9c0 IVDR \uc801\ud569 QMS \uad6c\ucd95\uc774 \uacf5\ud1b5 \uc870\uac74\uc774\uba70, \uac01 \ub4f1\uae09\ubcc4 \uc2e0\uccad \ub9c8\uac10\uc77c \uc774\ud6c4 4\uac1c\uc6d4 \uc774\ub0b4<br \/>\uc778\uc99d\uae30\uad00\uacfc\uc758 \uc11c\uba74 \uacc4\uc57d \uccb4\uacb0\uc774 \ud544\uc694\ud569\ub2c8\ub2e4.<\/li><li style=\"list-style-type: none;\"><span style=\"color: #003300;\"><span style=\"font-weight: 600;\">\ucd5c\uc2e0\ub3d9\ud5a5 : IVDR \uac04\uc18c\ud654 \uac1c\uc815\uc548(2025\ub144 12\uc6d4)<\/span><\/span><\/li><li style=\"margin-bottom: 10px; list-style-type: none;\">\uc720\ub7fd\uc9d1\ud589\uc704\uc6d0\ud68c\ub294 2025\ub144 12\uc6d4 16\uc77c MDR\uacfc \ud568\uaed8 IVDR\uc5d0 \ub300\ud55c \uac04\uc18c\ud654 \uac1c\uc815 \uc81c\uc548(COM(2025)1023)\uc744 \ubc1c\ud45c\ud558\uc600\uc2b5\ub2c8\ub2e4.<br \/>\ud589\uc815 \ubd80\ub2f4 \uc644\ud654, \uc778\uc99d \uc608\uce21 \uac00\ub2a5\uc131 \ud5a5\uc0c1, \ud601\uc2e0 \ucd09\uc9c4\uc744 \ubaa9\ud45c\ub85c \ud558\uba70 \ud604\uc7ac \uc720\ub7fd\uc758\ud68c \ubc0f \uc774\uc0ac\ud68c \uac80\ud1a0 \uc911\uc73c\ub85c\u00a0<span style=\"font-weight: 600;\">\ube60\ub974\uba74 2026\ub144 \ub9d0 \uc774\ud6c4 \ubc1c\ud6a8 \uc608\uc0c1<\/span>\uc785\ub2c8\ub2e4.<br \/>\ub2e8, \uc774 \uac1c\uc815\uc548\uc740 \ud604\uc7ac \uc801\uc6a9 \uc911\uc778 \uc804\ud658\uae30\uac04\uc5d0\ub294 \uc601\ud5a5\uc744 \ubbf8\uce58\uc9c0 \uc54a\uc2b5\ub2c8\ub2e4.<\/li><\/ul><\/li><\/ul><\/div><h2 style=\"font-family: Tahoma, sans-serif; font-size: 25px; text-transform: uppercase; padding-left: 40px;\"><span style=\"color: #003300;\">\uc778\uc99d \ud6a8\uacfc<\/span><\/h2><div style=\"color: #606060; font-family: 'Open Sans', 'Helvetica Neue', helvetica, arial, sans-serif; font-size: 16px;\"><div><ul><li style=\"list-style-type: none;\"><ul><li>\uc77c\ubc18 \uc548\uc804 \uc131\ub2a5 \uc694\uad6c\uc0ac\ud56d(GSPR)\uc744 \ucda9\uc871\uc2dc\ud0b4\uc73c\ub85c\uc368 \uc548\uc804\ud55c \uc81c\ud488\uc744 \uc18c\ube44\uc790\uc5d0\uac8c \uc81c\uacf5<\/li><li>EU\u00a0 \ud68c\uc6d0\uad6d \uc218\ucd9c\uc5d0 \uc81c\ud55c\uc774 \uc5c6\uc74c (EU \ud68c\uc6d0\uad8c \ub0b4 \ubaa8\ub4e0 \uc81c\ud488\uc5d0 CE Mark \uc758\ubb34\ud654)<\/li><li>CE Mark \ubd80\ucc29\uc744 \ud1b5\ud574 EU \uc774\uc678\uc758 \uad6d\uac00 \uc218\ucd9c \uc2dc \uc218\ucd9c\uacbd\uc7c1\ub825 \uac15\ud654<\/li><li>\uc81c\ud488\uc758 \uc548\uc804\uc131 \uc785\uc99d\uc744 \ud1b5\ud55c \uc18c\uc1a1 \uc704\ud5d8 \uac10\uc18c<\/li><li>\ud68c\uc0ac \u00b7 \uc81c\ud488 \u00b7 \ube0c\ub79c\ub4dc \uc774\ubbf8\uc9c0\uc640 \uc2e0\ub8b0\uc131 \ud5a5\uc0c1<\/li><\/ul><\/li><\/ul><\/div><div><span style=\"font-weight: bold;\">\u00a0<\/span><\/div><\/div><div style=\"color: #606060; font-family: 'Open Sans', 'Helvetica Neue', helvetica, arial, sans-serif; font-size: 16px;\">\u00a0<\/div><div style=\"color: #606060; font-family: 'Open Sans', 'Helvetica Neue', helvetica, arial, sans-serif; font-size: 16px;\"><div style=\"padding-left: 40px;\"><img decoding=\"async\" src=\"https:\/\/fda-certi.org\/wp-content\/uploads\/2026\/04\/%EC%A7%80%EC%82%AC-scaled.png\" alt=\"\" width=\"900\" height=\"105\" \/><\/div><\/div>\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\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-e48b077 e-flex e-con-boxed e-con e-parent\" data-id=\"e48b077\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4082abd elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"4082abd\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-d8b3141 e-flex e-con-boxed e-con e-parent\" data-id=\"d8b3141\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-debb997 elementor-widget elementor-widget-heading\" data-id=\"debb997\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">\ube60\ub978 \ubb38\uc758 \ud558\uae30<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-cadc6b6 e-flex e-con-boxed e-con e-parent\" data-id=\"cadc6b6\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-ab318f1 e-flex e-con-boxed e-con e-child\" data-id=\"ab318f1\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f986e5e elementor-widget elementor-widget-text-editor\" data-id=\"f986e5e\" 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\t\t\n<div class=\"wpcf7 no-js\" id=\"wpcf7-f353-o1\" lang=\"ko-KR\" dir=\"ltr\" data-wpcf7-id=\"353\">\n<div class=\"screen-reader-response\"><p role=\"status\" aria-live=\"polite\" aria-atomic=\"true\"><\/p> <ul><\/ul><\/div>\n<form action=\"\/index.php?rest_route=%2Fwp%2Fv2%2Fpages%2F51#wpcf7-f353-o1\" method=\"post\" class=\"wpcf7-form init\" aria-label=\"\ubb38\uc758 \uc591\uc2dd\" novalidate=\"novalidate\" data-status=\"init\">\n<fieldset class=\"hidden-fields-container\"><input type=\"hidden\" name=\"_wpcf7\" value=\"353\" \/><input type=\"hidden\" name=\"_wpcf7_version\" value=\"6.1.4\" \/><input type=\"hidden\" name=\"_wpcf7_locale\" value=\"ko_KR\" \/><input type=\"hidden\" name=\"_wpcf7_unit_tag\" value=\"wpcf7-f353-o1\" \/><input type=\"hidden\" name=\"_wpcf7_container_post\" value=\"0\" \/><input type=\"hidden\" name=\"_wpcf7_posted_data_hash\" value=\"\" \/>\n<\/fieldset>\n<style>\ntable.type01 {\nborder-collapse: collapse;\n text-align: left;\n line-height: 1.5;\n margin : 20px 10px;\n}\ntable.type01 th {\n width: 150px;\n padding: 10px;\n font-weight: bold;\n vertical-align: top;\n border: 0px solid #ccc;\n}\ntable.type01 td {\n width: 350px;\n padding: 10px;\n vertical-align: top;\n border: 0px solid #ccc;\n}\ntable.type01 .tg-baqh{text-align:center;vertical-align:top}\n<\/style>\n<table class=\"type01\" >\n\t<tr>\n\t\t<td>\n\t\t\t<p><label>1.\ud68c\uc0ac\uba85(*)<span class=\"wpcf7-form-control-wrap\" data-name=\"text-494\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"text-494\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/td>\n\t\t<td>\n\t\t\t<p><label>2.\ub2f4\ub2f9\uc790\uba85(*)<span class=\"wpcf7-form-control-wrap\" data-name=\"your-name\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"your-name\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/td>\n\t<\/tr>\n\t<tr>\n\t\t<td>\n\t\t\t<p><label>3.\uc774\uba54\uc77c(*)<span class=\"wpcf7-form-control-wrap\" data-name=\"your-email\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-email wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-email\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"email\" name=\"your-email\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/td>\n\t\t<td>\n\t\t\t<p><label>4.\uc5f0\ub77d\ucc98(*)<span class=\"wpcf7-form-control-wrap\" data-name=\"tel-139\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-tel wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-tel\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"tel\" name=\"tel-139\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/td>\n\t<\/tr>\n\t<tr>\n\t\t<td colspan=\"2\">\n\t\t\t<p><label>5.\ubb38\uc758\uc885\ub958(\ubcf5\uc218\uc120\ud0dd\uac00\ub2a5) : <\/label><span class=\"wpcf7-form-control-wrap\" data-name=\"checkbox-388\"><span class=\"wpcf7-form-control wpcf7-checkbox\"><span class=\"wpcf7-list-item first\"><input type=\"checkbox\" name=\"checkbox-388[]\" value=\"\uc720\ub7fdCE\uc778\uc99d\" \/><span class=\"wpcf7-list-item-label\">\uc720\ub7fdCE\uc778\uc99d<\/span><\/span><span class=\"wpcf7-list-item\"><input type=\"checkbox\" name=\"checkbox-388[]\" value=\"\ubbf8\uad6d FDA\uc778\uc99d\" \/><span class=\"wpcf7-list-item-label\">\ubbf8\uad6d FDA\uc778\uc99d<\/span><\/span><span class=\"wpcf7-list-item\"><input type=\"checkbox\" name=\"checkbox-388[]\" value=\"\uae30\uc220\uc9c0\uc6d0(\ubc38\ub9ac\ub370\uc774\uc158)\" \/><span class=\"wpcf7-list-item-label\">\uae30\uc220\uc9c0\uc6d0(\ubc38\ub9ac\ub370\uc774\uc158)<\/span><\/span><span class=\"wpcf7-list-item last\"><input type=\"checkbox\" name=\"checkbox-388[]\" value=\"\uae30\ud0c0\" \/><span class=\"wpcf7-list-item-label\">\uae30\ud0c0<\/span><\/span><\/span><\/span>\n\t\t\t<\/p>\n\t\t<\/td>\n\t<\/tr>\n\t<tr>\n\t\t<td colspan=\"2\">\n\t\t\t<p><label>6.\ubb38\uc758\ubd84\uc57c(\ubcf5\uc218\uc120\ud0dd\uac00\ub2a5) : <\/label><span class=\"wpcf7-form-control-wrap\" data-name=\"checkbox-389\"><span class=\"wpcf7-form-control wpcf7-checkbox\"><span class=\"wpcf7-list-item first\"><input type=\"checkbox\" name=\"checkbox-389[]\" value=\"\uc758\ub8cc\uae30\uae30\" \/><span class=\"wpcf7-list-item-label\">\uc758\ub8cc\uae30\uae30<\/span><\/span><span class=\"wpcf7-list-item\"><input type=\"checkbox\" name=\"checkbox-389[]\" value=\"\ud654\uc7a5\ud488\" \/><span class=\"wpcf7-list-item-label\">\ud654\uc7a5\ud488<\/span><\/span><span class=\"wpcf7-list-item\"><input type=\"checkbox\" name=\"checkbox-389[]\" value=\"\uc2dd\ud488\" \/><span class=\"wpcf7-list-item-label\">\uc2dd\ud488<\/span><\/span><span class=\"wpcf7-list-item\"><input type=\"checkbox\" name=\"checkbox-389[]\" value=\"\uc18c\ud504\ud2b8\uc6e8\uc5b4\" \/><span class=\"wpcf7-list-item-label\">\uc18c\ud504\ud2b8\uc6e8\uc5b4<\/span><\/span><span class=\"wpcf7-list-item\"><input type=\"checkbox\" name=\"checkbox-389[]\" value=\"\ud3ec\uc7a5\uc7ac\" \/><span class=\"wpcf7-list-item-label\">\ud3ec\uc7a5\uc7ac<\/span><\/span><span class=\"wpcf7-list-item\"><input type=\"checkbox\" name=\"checkbox-389[]\" value=\"\ud654\ud559\ubb3c\uc9c8\" \/><span class=\"wpcf7-list-item-label\">\ud654\ud559\ubb3c\uc9c8<\/span><\/span><span class=\"wpcf7-list-item last\"><input type=\"checkbox\" name=\"checkbox-389[]\" value=\"\uae30\ud0c0\" \/><span class=\"wpcf7-list-item-label\">\uae30\ud0c0<\/span><\/span><\/span><\/span>\n\t\t\t<\/p>\n\t\t<\/td>\n\t<\/tr>\n\t<tr>\n\t\t<td colspan=\"2\">\n\t\t\t<p><label>7.\uc81c\ud488\uc815\ubcf4<span class=\"wpcf7-form-control-wrap\" data-name=\"text-428\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"text-428\" \/><\/span><\/label>\n\t\t\t<\/p>\n\t\t<\/td>\n\t<\/tr>\n\t<tr>\n\t\t<td colspan=\"2\">\n\t\t\t<p><label>8.\ubb38\uc758\ub0b4\uc6a9(\ucd5c\ub300\ud55c\uc0c1\uc138\ud788) <\/label>\n\t\t\t<\/p>\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"textarea-909\"><textarea cols=\"40\" rows=\"10\" maxlength=\"2000\" class=\"wpcf7-form-control wpcf7-textarea\" aria-invalid=\"false\" name=\"textarea-909\"><\/textarea><\/span>\n\t\t\t<\/p>\n\t\t<\/td>\n\t<\/tr>\n\t<tr>\n\t\t<td class=\"tg-baqh\" colspan=\"2\">\n\t\t\t<p><label><span class=\"wpcf7-form-control-wrap\" data-name=\"checkbox-102\"><span class=\"wpcf7-form-control wpcf7-checkbox wpcf7-validates-as-required wpcf7-exclusive-checkbox\"><span class=\"wpcf7-list-item first last\"><input type=\"checkbox\" name=\"checkbox-102\" value=\"\uac1c\uc778\uc815\ubcf4 \uc218\uc9d1 \ubc0f \uc774\uc6a9 \ub3d9\uc758\" \/><span class=\"wpcf7-list-item-label\">\uac1c\uc778\uc815\ubcf4 \uc218\uc9d1 \ubc0f \uc774\uc6a9 \ub3d9\uc758<\/span><\/span><\/span><\/span><\/label><a href=\"https:\/\/ce-certi.or.kr\/?page_id=3\"><span id=\"terms-link\" style=\"color:red;\">\ubcf4\uae30<\/span><\/a>\n\t\t\t<\/p>\n\t\t<\/td>\n\t<\/tr>\n\t<tr>\n\t\t<td  class=\"tg-baqh\" colspan=\"2\">\n\t\t\t<p><input class=\"wpcf7-form-control wpcf7-submit has-spinner\" type=\"submit\" value=\"\ube60\ub978 \ubb38\uc758\ud558\uae30&gt;&gt;\" \/>\n\t\t\t<\/p>\n\t\t<\/td>\n\t<\/tr>\n<\/table><div class=\"wpcf7-response-output\" aria-hidden=\"true\"><\/div>\n<\/form>\n<\/div>\n\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\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c43b88d e-flex e-con-boxed e-con e-parent\" data-id=\"c43b88d\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6b8c529 elementor-widget elementor-widget-image\" data-id=\"6b8c529\" 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\t<a href=\"https:\/\/ce-certi.or.kr\/?page_id=560\">\n\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"140\" src=\"https:\/\/ce-certi.or.kr\/wp-content\/uploads\/2024\/02\/cont2-1024x140.jpg\" class=\"attachment-large size-large wp-image-478\" alt=\"\" srcset=\"https:\/\/ce-certi.or.kr\/wp-content\/uploads\/2024\/02\/cont2-1024x140.jpg 1024w, https:\/\/ce-certi.or.kr\/wp-content\/uploads\/2024\/02\/cont2-300x41.jpg 300w, https:\/\/ce-certi.or.kr\/wp-content\/uploads\/2024\/02\/cont2-768x105.jpg 768w, https:\/\/ce-certi.or.kr\/wp-content\/uploads\/2024\/02\/cont2-1536x209.jpg 1536w, https:\/\/ce-certi.or.kr\/wp-content\/uploads\/2024\/02\/cont2-18x2.jpg 18w, https:\/\/ce-certi.or.kr\/wp-content\/uploads\/2024\/02\/cont2.jpg 2048w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\t\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\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>CE-IVDR \uccb4\uc678\uc9c4\ub2e8\uc758\ub8cc\uae30\uae30\u00a0_IVDR (In Vitro Diagnostic Medical Devices Regulation) \ub3c4\uc785\uc2dc\uae30 \uc758\ub8cc\uae30\uae30\uc5d0 \uad00\ud55c EU \uaddc\uc815(MDR: Medical Device Regulation)\uacfc \ubd80\ud569\ud558\uc5ec, \uc720\ub7fd \uc758\ud68c\uc640 \uc704\uc6d0\ud68c\uc758 \uccb4\uc678\uc9c4\ub2e8\uc758\ub8cc\uae30\uae30 \uaddc\uc8152017\/746(IVDR: In Vitro Diagnostic Regulation)\uc774 2017\ub144 5\uc6d4 26\uc77c\uc5d0 \ubc1c\ud6a8\ub418\uc5c8\uc73c\uba70,\u00a02022\ub144 5\uc6d4 26\uc77c\ubd80\ud130 \uc801\uc6a9\uc774 \uac1c\uc2dc\ub418\uc5c8\uc2b5\ub2c8\ub2e4. \uad6c\ubc95\uc778 IVDD(\uc9c0\uce68, Directive)\uc5d0\uc11c IVDR(\uaddc\uc815, Regulation)\uc73c\ub85c \uc0c1\ud5a5\ub418\uc5c8\uc73c\uba70, IVDR\uc740 \uccb4\uc678\uc9c4\ub2e8\uc6a9 \uc758\ub8cc\uae30\uae30\uc5d0 \ub300\ud55c EU\uc758\ud604\ud589 \uc9c0\uce68 IVDD(98\/79\/EC)\ub97c \ub300\uccb4\ud558\uc5ec \uc720\ub7fd\uc5d0 \uc720\ud1b5\ub418\ub294 \ubaa8\ub4e0 \uc81c\ud488\uc774 \ub300\uc0c1\uc774 \ub429\ub2c8\ub2e4. \uc801\uc6a9\ub300\uc0c1\ud488\ubaa9 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-51","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/ce-certi.or.kr\/index.php?rest_route=\/wp\/v2\/pages\/51","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ce-certi.or.kr\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/ce-certi.or.kr\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/ce-certi.or.kr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/ce-certi.or.kr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=51"}],"version-history":[{"count":42,"href":"https:\/\/ce-certi.or.kr\/index.php?rest_route=\/wp\/v2\/pages\/51\/revisions"}],"predecessor-version":[{"id":1592,"href":"https:\/\/ce-certi.or.kr\/index.php?rest_route=\/wp\/v2\/pages\/51\/revisions\/1592"}],"wp:attachment":[{"href":"https:\/\/ce-certi.or.kr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=51"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}