{"id":2821,"date":"2026-05-06T11:41:17","date_gmt":"2026-05-06T02:41:17","guid":{"rendered":"https:\/\/mediwhale.com\/ko\/?post_type=news&#038;p=2821"},"modified":"2026-05-07T11:45:51","modified_gmt":"2026-05-07T02:45:51","slug":"%eb%a9%94%eb%94%94%ec%9b%a8%ec%9d%bc-%eb%8b%a5%ed%84%b0%eb%88%88-%ec%9c%a0%eb%9f%bd-ce-mdr%ec%84%9c-%ec%8b%ac%ed%98%88%ea%b4%80-%ec%9c%84%ed%97%98-%ec%98%88%ec%b8%a1-%ec%9d%98","status":"publish","type":"news","link":"https:\/\/mediwhale.com\/ko\/news\/%eb%a9%94%eb%94%94%ec%9b%a8%ec%9d%bc-%eb%8b%a5%ed%84%b0%eb%88%88-%ec%9c%a0%eb%9f%bd-ce-mdr%ec%84%9c-%ec%8b%ac%ed%98%88%ea%b4%80-%ec%9c%84%ed%97%98-%ec%98%88%ec%b8%a1-%ec%9d%98\/","title":{"rendered":"\uba54\ub514\uc6e8\uc77c \u2018\ub2e5\ud130\ub208\u2019, \uc720\ub7fd CE MDR\uc11c \uc2ec\ud608\uad00 \uc704\ud5d8 \uc608\uce21 \uc758\ub8cc\uae30\uae30\ub85c \ud5c8\uac00"},"content":{"rendered":"\n<p>&#8211; \uc2ec\ud608\uad00 \uc704\ud5d8 \uc608\uce21 \uc0ac\uc6a9 \ubaa9\uc801 \uacf5\uc2dd \uc778\uc815\u2026\uc9c4\ub2e8 \ub118\uc5b4 AI \uc608\ubc29 \uc2e4\ud604<\/p>\n\n\n\n<p>\uc758\ub8cc AI \uae30\uc5c5 \uba54\ub514\uc6e8\uc77c(\ub300\ud45c \ucd5c\ud0dc\uadfc)\uc740 \ub9dd\ub9c9 AI \uc194\ub8e8\uc158 \u2018\ub2e5\ud130\ub208(DrNoon)\u2019\uc774 \uc720\ub7fd \uc758\ub8cc\uae30\uae30 \uaddc\uc815 CE MDR(Medical Device Regulation) \uc778\uc99d\uc744 \ud68d\ub4dd\ud588\ub2e4\uace0 6\uc77c \ubc1d\ud614\ub2e4.<\/p>\n\n\n\n<p>CE MDR\uc740 \uc720\ub7fd \uc2dc\uc7a5\uc5d0\uc11c \uc758\ub8cc\uae30\uae30\ub97c \ud310\ub9e4\u00b7\uacf5\uae09\ud558\uae30 \uc704\ud574 \ucda9\uc871\ud574\uc57c \ud558\ub294 \uc720\ub7fd\uc5f0\ud569\uc758 \uc758\ub8cc\uae30\uae30 \uaddc\uc815\uc774\ub2e4. \uae30\uc874 \uc758\ub8cc\uae30\uae30 \uc9c0\uce68\uc778 MDD(Medical Device Directive)\ub97c \ub300\uccb4\ud574 2021\ub144\ubd80\ud130 \uc2dc\ud589\ub410\ub2e4. \uc81c\ud488 \uc548\uc804\uc131, \uc784\uc0c1\uc801 \uadfc\uac70, \ud488\uc9c8\uad00\ub9ac \uccb4\uacc4, \uc0ac\ud6c4 \uac10\uc2dc \ub4f1\uc5d0 \ub300\ud55c \uc694\uad6c \uc218\uc900\uc744 \ud55c\uce35 \uac15\ud654\ud55c \uc81c\ub3c4\ub2e4.<\/p>\n\n\n\n<p>\ub2e5\ud130\ub208\uc740 \ub9dd\ub9c9 \uc774\ubbf8\uc9c0\ub97c \ubd84\uc11d\ud574 \uc548\uc9c8\ud658 \uc9c4\ub2e8\uc744 \ubcf4\uc870\ud558\uace0 \uc2ec\ud608\uad00\uc9c8\ud658 \uc704\ud5d8\uc744 \uc2ec\uc7a5 CT\uc640 \uc720\uc0ac\ud55c \uc815\ud655\ub3c4\ub85c \uc608\uce21\ud558\ub294 AI \uc758\ub8cc\uae30\uae30\ub2e4. \uad6d\ub0b4\uc5d0\uc11c \ud604\uc7ac \uc720\ud1b5 \uc911\uc778 \uc548\uc9c8\ud658 \uc9c4\ub2e8\ubcf4\uc870 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \u2018\ub2e5\ud130\ub208 \ud380\ub354\uc2a4\u2019\uc640 \uc2ec\ud608\uad00\uc9c8\ud658 \uc704\ud5d8 \ud3c9\uac00 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \u2018\ub2e5\ud130\ub208 CVD\u2019\ub97c \ud558\ub098\ub85c \ud1b5\ud569\ud55c \ub9dd\ub9c9 AI \uc194\ub8e8\uc158\uc774\ub2e4.<\/p>\n\n\n\n<p>\uba54\ub514\uc6e8\uc77c\uc740 \uc774\ubc88 CE MDR \uc778\uc99d\uc744 \ud1b5\ud574 \uc720\ub7fd\uc5f0\ud569(EU) 27\uac1c \ud68c\uc6d0\uad6d\uc5d0\uc11c \ub2e5\ud130\ub208\uc744 \ud310\ub9e4\u00b7\uacf5\uae09\ud560 \uc218 \uc788\ub294 \uaddc\uc81c \uae30\ubc18\uc744 \ub9c8\ub828\ud588\ub2e4. \ub610\ud55c \ub2e5\ud130\ub208\uc740 \ub9dd\ub9c9 AI \ubd84\uc57c\uc5d0\uc11c \uc720\ub7fd\uc758 \uac15\ud654\ub41c \uc758\ub8cc\uae30\uae30 \uaddc\uc81c \uae30\uc900\uc744 \ucda9\uc871\ud558\uba70 \uae00\ub85c\ubc8c \uc778\ud5c8\uac00 \uacbd\uc7c1\ub825\uc744 \uc785\uc99d\ud588\ub2e4.<\/p>\n\n\n\n<p>\ud2b9\ud788 \uc774\ubc88 \uc778\uc99d\uc740 \uae4c\ub2e4\ub85c\uc6b4 \uc720\ub7fd MDR \uccb4\uc81c \ub0b4\uc5d0\uc11c\ub3c4 \uc0ac\ub840\uac00 \ub4dc\ubb38 \u2018\uc608\uce21\u2019 \ubaa9\uc801\uc73c\ub85c \uc778\uc99d\ubc1b\uc558\ub2e4\ub294 \uc810\uc5d0\uc11c \uadf8 \uc758\ubbf8\uac00 \ud06c\ub2e4. \uc774\ub97c \ud1b5\ud574 \uba54\ub514\uc6e8\uc77c\uc740 \uae30\uc874\uc758 \uc9c8\ubcd1 \uc9c4\ub2e8 \ubcf4\uc870\uc5d0 \uba38\ubb3c\ub7ec \uc788\ub358 \uc758\ub8cc AI \uc2dc\uc7a5\uc5d0\uc11c \ub2e5\ud130\ub208\ub9cc\uc758 \ud655\uace0\ud55c \ucc28\ubcc4\uc131\uc744 \uac1d\uad00\uc801\uc73c\ub85c \uc785\uc99d\ud588\ub2e4.<\/p>\n\n\n\n<p>\uba54\ub514\uc6e8\uc77c\uc740 \uc774\ubc88 \uc131\uacfc\uac00 \ud574\uc678 \uc758\ub8cc\uae30\uad00 \ubc0f \ud30c\ud2b8\ub108\uc0ac\uc640\uc758 \ud611\ub825 \ub17c\uc758\uc5d0\uc11c\ub3c4 \uc81c\ud488 \uc2e0\ub8b0\ub3c4\ub97c \ub192\uc774\ub294 \uacc4\uae30\uac00 \ub420 \uac83\uc73c\ub85c \uae30\ub300\ud558\uace0 \uc788\ub2e4. \ud2b9\ud788 \ubbf8\uad6d \uc2dd\ud488\uc758\uc57d\uad6d \ub4dc \ub178\ubcf4(De Novo) \uc808\ucc28\uc640 \ud568\uaed8 \uc720\ub7fd CE MDR \uc778\uc99d\uc744 \ud655\ubcf4\ud568\uc73c\ub85c\uc368 \ub2e5\ud130\ub208\uc758 \uae00\ub85c\ubc8c \uaddc\uc81c \uc804\ub7b5\uc5d0\ub3c4 \uc18d\ub3c4\uac00 \ubd99\uc744 \uc804\ub9dd\uc774\ub2e4.<\/p>\n\n\n\n<p>\ucd5c\ud0dc\uadfc \uba54\ub514\uc6e8\uc77c \ub300\ud45c\ub294 \u201c\uc774\ubc88 \uc778\uc99d\uc5d0\uc11c \u2018\uc2ec\ud608\uad00 \uc704\ud5d8 \uc608\uce21\u2019\uc774 \ub2e5\ud130\ub208\uc758 \uc0ac\uc6a9 \ubaa9\uc801\uc73c\ub85c \uba85\uc2dc\ub41c \uac83\uc740 \ub9dd\ub9c9 AI \uae30\ubc18 \uc804\uc2e0 \uc9c8\ud658 \uc704\ud5d8 \ud3c9\uac00\ub77c\ub294 \ucc28\ubcc4\ud654\ub41c \ubc29\ud5a5\uc131\uc744 \ubcf4\uc5ec\uc8fc\ub294 \uc911\uc694\ud55c \uc131\uacfc\u201d\ub77c\uba70 \u201c\uc774\ub97c \ubc1c\ud310\uc73c\ub85c \uc720\ub7fd \uc758\ub8cc \ud604\uc7a5 \uc801\uc6a9\uc744 \ud655\ub300\ud558\uace0, \uae00\ub85c\ubc8c \ud30c\ud2b8\ub108\uc2ed\uc744 \uac15\ud654\ud574 \uc2dc\uc7a5 \ud655\uc7a5\uc5d0 \uc18d\ub3c4\ub97c \ub0b4\uaca0\ub2e4\u201d\uace0 \ubc1d\ud614\ub2e4.<\/p>\n\n\n\n<p>\uba54\ub514\uc6e8\uc77c\uc740 \ub2e5\ud130\ub208\uc758 \uae00\ub85c\ubc8c \ud655\uc7a5\uacfc \uc0ac\uc5c5\ud654\uc5d0 \uc18d\ub3c4\ub97c \ub0b4\uace0 \uc788\ub2e4. \ub2e5\ud130\ub208 CVD\ub294 \ubbf8\uad6d \uc2dd\ud488\uc758\uc57d\uad6d(FDA) \ub4dc \ub178\ubcf4(De Novo) \ud5c8\uac00 \uc808\ucc28\ub97c \uc9c4\ud589 \uc911\uc774\ub2e4. \ud6c4\uc18d 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