{"id":54,"date":"2023-07-28T12:53:29","date_gmt":"2023-07-28T03:53:29","guid":{"rendered":"https:\/\/ce-certi.or.kr\/?page_id=54"},"modified":"2026-04-13T15:08:02","modified_gmt":"2026-04-13T06:08:02","slug":"ce-mdr","status":"publish","type":"page","link":"https:\/\/ce-certi.or.kr\/?page_id=54","title":{"rendered":"CE-MDR"},"content":{"rendered":"\t\t
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CE-MDR
<\/span>\uc720\ub7fd\uc758\ub8cc\uae30\uae30 \uaddc\uc815<\/span> _MDR (Medical Devices Regulation)<\/span><\/p>

\ub3c4\uc785\uc2dc\uae30<\/span><\/h2>

CE MDR(\uc758\ub8cc\uae30\uae30 \uaddc\uc815, Medical Devices Regulation)\uc740 \uae30\uc874 EU\uc758 \uc77c\ubc18 \uc758\ub8cc\uae30\uae30 \uc9c0\uce68(Medical Devices Directive, 93\/42\/EEC) \ubc0f
\ub2a5\ub3d9\ud615 \uc774\uc2dd \uc758\ub8cc\uae30\uae30 \uc9c0\uce68(Active Implantable Medical Devices Directive, 90\/385\/EEC) \ub4f1 2\uac1c \uc9c0\uce68\uc744 1\uac1c\ub85c \ud1b5\ud569\ud55c \uc2e0\uaddc \uaddc\uc815\uc73c\ub85c
2017\ub144 4\uc6d4 5\uc77c \uacf5\ud45c\ub418\uc5c8\uc73c\uba70, 2017\ub144 5\uc6d4 \ubc1c\ud6a8 \ud6c4 2021\ub144 5\uc6d4 26\uc77c\ubd80\ud130 \uc801\uc6a9\uc774 \uac1c\uc2dc<\/span>\ub418\uc5c8\uc2b5\ub2c8\ub2e4.<\/p>

\uc720\ub7fd\uc5f0\ud569(EU)\uc758 \uc0c8\ub85c\uc6b4 \uc758\ub8cc\uae30\uae30 \uaddc\uc815\uc778 MDR [Medical Devices Regulation (MDR 2017\/745)]\uc740 \ud658\uc790\uc758 \uc548\uc804\uc744 \uac15\ud654\ud558\uace0,
\uacf5\uc911 \ubcf4\uac74\uc744 \ud604\ub300\ud654\ud558\uae30 \uc704\ud55c \uc758\ub8cc\uae30\uae30 \uc0b0\uc5c5\uc758 \uc0c8\ub85c\uc6b4 \ub3c4\uc57d\uc785\ub2c8\ub2e4.<\/p>

\uc778\uc99d\ub300\uc0c1<\/span><\/h2>

\uc758\ub8cc\uae30\uae30(Medical Devices) \ubc0f \ub2a5\ub3d9 \uc774\uc2dd\ud615 \uc758\ub8cc\uae30\uae30(Active Implantable Medical Devices)<\/p>

\uc801\uc6a9\ub300\uc0c1\ud488\ubaa9<\/span><\/h2>

\ubaa9\uc801 \ubc0f \uc704\ud5d8\uc131\uc5d0 \ub530\ub77c \ub4f1\uae09 I(\uc800\uc704\ud5d8\uad70), IIa, IIb\uc640 III(\uace0\uc704\ud5d8\uad70) \ub4f1 4\uac00\uc9c0 \uc81c\ud488\uad70(Class)\uc73c\ub85c \ubd84\ub958<\/p>

    • Class I<\/span>: \ubaa8\ub4e0 \ube44\uc0bd\uc785 \uae30\uad6c, \uc77c\uc2dc\uc801 \ub610\ub294 \ub2e8\uae30\uac04 \uc0ac\uc6a9\ub418\ub294 \uc0bd\uc785\uae30\uad6c, \uc7ac\uc0ac\uc6a9 \uac00\ub2a5\ud55c \uc678\uacfc\uc801 \uae30\uae30
                    (\uc77c\ubc18 \uc758\ub8cc\uae30\uae30\ub958\ub85c \ud720\uccb4\uc5b4, \uad50\uc815\uc6a9 \uc548\uacbd, \ubcd1\uc6d0\uc6a9 \uce68\ub300 \ub4f1)<\/li>
    • Class IIa<\/span>: \uad6c\uac15\uc6a9 \uae30\uad6c \ubc0f \uc678\uacfc \uc0bd\uc785\uae30\uad6c, \uc704\ud5d8\uc131\uc774 \uc5c6\ub294 \uce58\ub8cc, \uc790\uae30\uc9c4\ub2e8\uae30\uae30, X-ray \uc9c4\ub2e8\uc601\uc0c1 \uae30\ub85d\uc744 \uc704\ud55c
                       \ube44\uc791\ub3d9\uae30\uad6c \ubc0f \uc678\uacfc\uc218\uc220\uc6a9 \uc758\ub8cc\uae30\uae30 (\uc608: MRI, \ucd08\uc74c\ud30c\uc9c4\ub2e8\uae30)<\/li>
    • Class IIb<\/span>: \uc704\ud5d8\uc131\uc744 \ub0b4\ud3ec\ud55c \uce58\ub8cc, \uc790\uae30\uc9c4\ub2e8\uae30\uae30, \ucf58\ud0dd\ud2b8\ub80c\uc988 \uc18c\ub3c5 \ub610\ub294 \uc138\ucc99 \uc7a5\uce58, \uce58\ub8cc\uc6a9 \uc791\ub3d9 \uae30\uae30 \ubc0f \uc678\uacfc\uc218\uc220\uc6a9 \uc758\ub8cc\uae30\uae30
                        (\uc608: \uc804\uae30\uc218\uc220\uae30 \ub4f1)<\/li>
    • Class III<\/span>: \uc77c\uc2dc\uc801 \ub610\ub294 \ub2e8\uae30\uac04 \uc0ac\uc6a9\ub418\ub294 \uc678\uacfc\uc801 \uc0bd\uc785\uae30\uad6c\ub85c \uc2ec\uc7a5\uc774\ub098 \uc2e0\uacbd\uacc4\ud1b5\uacfc \uc811\ucd09\ud574 \uc9c4\ub2e8, \ubaa8\ub2c8\ud130\ub9c1 \uc704\ud55c \uae30\uad6c.
                      \uc7a5\uae30\uac04 \uc0ac\uc6a9\ub418\ub294 \uc774\uc2dd\uc6a9 \uae30\uad6c \ubc0f \uc678\uacfc\uc801 \uc0bd\uc785\uae30\uad6c (\uc608: \uc778\uacf5\uc2ec\ud3d0\uae30)<\/li><\/ul><\/li><\/ul>

      \ud655\ub300 \uc801\uc6a9\ud488\ubaa9<\/span> \ucf58\ud0dd\ud2b8\ub80c\uc988, \ub1cc\uc790\uadf9\uae30\uae30 \ub4f1 \ubbf8\uc6a9 \uad00\ub828 \uc81c\ud488\uacfc \ube44\uc758\ub8cc\uc6a9 \uc81c\ud488(\uc138\ubd80 \ud488\ubaa9 \ub9ac\uc2a4\ud2b8\ub294 \ubd80\uc18d\uc11c XVI \ucc38\uace0)<\/p>

      MDR \uc8fc\uc694 \ubcc0\uacbd\uc0ac\ud56d<\/span><\/h2>
        • \uaddc\uc815 \uc900\uc218 \ucc45\uc784\uc790\uc5d0 \ub300\ud55c \uc694\uad6c\uc0ac\ud56d \uac15\ud654 (\uc81c\uc870\uc790, \uc720\ub7fd\ub300\ub9ac\uc778 \ub4f1)<\/li>
        • \uc758\ub8cc\uae30\uae30 \uace0\uc720 \uc2dd\ubcc4 \ucf54\ub4dc(UDI, Unique Device Identification) \uc2dc\uc2a4\ud15c \uc801\uc6a9 \u2014 Class III\u00b7IIb\ubd80\ud130 \uc21c\ucc28 \uc758\ubb34\ud654 \uc9c4\ud589 \uc911<\/li>
        • \ud2b9\uc815 \uace0\uc704\ud5d8 \uc81c\ud488(Implantable Medical Device, Class III \ub4f1\uae09 \uc81c\ud488)\uc758 \uc5c4\uaca9\ud55c \uc784\uc0c1 \uc694\uad6c\uc0ac\ud56d<\/li>
        • \uc720\ub7fd \uc911\uc559 \ub370\uc774\ud130\ubca0\uc774\uc2a4(EUDAMED) \uad6c\ucd95 \ubc0f \uc758\ubb34\ud654 \u2014 2026\ub144 5\uc6d4 28\uc77c\ubd80\ud130 4\uac1c \ubaa8\ub4c8
          (\uacbd\uc81c \uc8fc\uccb4 \ub4f1\ub85d, UDI \ub370\uc774\ud130\ubca0\uc774\uc2a4, \uc778\uc99d\uae30\uad00 \ubc0f \uc778\uc99d\uc11c, \uc2dc\uc7a5 \uac10\uc2dc) \uc758\ubb34 \uc0ac\uc6a9 \uac1c\uc2dc<\/span><\/li>
        • \uc784\uc0c1 \ud3c9\uac00 \ubc0f \uac80\uc99d \uc2dc\ud5d8\uc758 \uc694\uad6c\uc0ac\ud56d \uac15\ud654<\/li>
        • \uacf5\ud1b5 \uae30\uc220 \uc0ac\uc591(Common Specifications)\uc5d0 \ub530\ub978 \uc801\ud569\uc131 \ud3c9\uac00 \uc801\uc6a9<\/li>
        • \uc81c\uc870\uc5c5\uccb4\uc5d0 \ub300\ud55c \uc2dc\ud310 \ud6c4 \uac10\uc2dc \uc694\uad6c\uc0ac\ud56d \uac15\ud654 (PMS, PSUR, SSCP \ub4f1)<\/li>
        • \uc758\ub8cc\uae30\uae30 \uc81c\ud488 \ubc94\uc8fc\uc758 \ud655\ub300 \u2014 \uceec\ub7ec \ucf58\ud0dd\ud2b8\ub80c\uc988, \ubbf8\uc6a9 \ubaa9\uc801\uc758 \uc774\uc2dd\ud615 \uae30\uae30 \ub4f1 \uc758\ub8cc \ubaa9\uc801\uc774 \uc5c6\ub294 \uae30\uae30 \ud3ec\ud568, \uc9c8\ubcd1\uc758
          \u2018\uc608\uce21 \ubc0f \uc608\ud6c4\u2019\ub97c \ubaa9\uc801\uc73c\ub85c \uc124\uacc4\ub41c \uc7a5\uce58\ub3c4 \ud3ec\ud568<\/li><\/ul><\/li><\/ul>

          \uc804\ud658\uae30\uac04 \ud604\ud669(2026\ub144 \uae30\uc900)<\/span><\/h2>

          2023\ub144 \ubc1c\ud6a8\ub41c \uac1c\uc815\uc548(Regulation (EU) 2023\/607)\uc5d0 \ub530\ub77c, \uae30\uc874 MDD\/AIMDD \uc778\uc99d\uc11c\uc758 \uc720\ud6a8\uae30\uac04\uacfc MDR\ub85c\uc758 \uc804\ud658 \uae30\ud55c\uc740
          \uc704\ud5d8 \ub4f1\uae09\uc5d0 \ub530\ub77c \ucc28\ub4f1 \uc801\uc6a9\ub429\ub2c8\ub2e4.<\/p>

          \"\"<\/p>

          \ucd5c\uc2e0\ub3d9\ud5a5 : MDR \uac04\uc18c\ud654 \uac1c\uc815\uc548(2025\ub14412\uc6d4)<\/span><\/span><\/p>

          \uc720\ub7fd\uc9d1\ud589\uc704\uc6d0\ud68c\ub294 2025\ub144 12\uc6d4 16\uc77c, MDR\uc758 \ubcf5\uc7a1\uc131\u00b7\ube44\uc6a9\u00b7\uc608\uce21 \ubd88\uac00\ub2a5\uc131 \ubb38\uc81c\ub97c \ud574\uacb0\ud558\uae30 \uc704\ud55c \uac04\uc18c\ud654 \uac1c\uc815 \uc81c\uc548(COM(2025)1023)\uc744 \ubc1c\ud45c\ud588\uc2b5\ub2c8\ub2e4.
          \uc8fc\uc694 \uc81c\uc548 \ub0b4\uc6a9\uc740 \ub2e4\uc74c\uacfc \uac19\uc73c\uba70, \ud604\uc7ac \uc720\ub7fd\uc758\ud68c \ubc0f \uc774\uc0ac\ud68c \uac80\ud1a0 \uc911\uc73c\ub85c \ube60\ub974\uba74 2026\ub144 \ub9d0 \uc774\ud6c4 \ubc1c\ud6a8 \uc608\uc0c1<\/span>\uc785\ub2c8\ub2e4.<\/p>

            • \ud601\uc2e0 \uae30\uae30(Breakthrough Device) \ubc0f \ud76c\uadc0 \uae30\uae30(Orphan Device) \uac1c\ub150 \ub3c4\uc785 \ubc0f \uc6b0\uc120\u00b7\ub864\ub9c1 \uc2ec\uc0ac \uc808\ucc28 \uc2e0\uc124<\/li>
            • \uc7ac\uc0ac\uc6a9 \uc218\uc220\uae30\uad6c, AI \uae30\ubc18 \uc18c\ud504\ud2b8\uc6e8\uc5b4 \ub4f1 \uc77c\ubd80 \uae30\uae30\uc758 \ub4f1\uae09 \ud558\ud5a5 \uc870\uc815 \uac80\ud1a0<\/li>
            • \uc758\ub8cc\uae30\uad00 \uc790\uccb4 \uc81c\uc870 \uae30\uae30(In-house Device) \uc694\uac74 \uc644\ud654<\/li>
            • \uc784\uc0c1\uc2dc\ud5d8 \uc808\ucc28 \uac04\uc18c\ud654 (\uc758\uc57d\ud488-\uc758\ub8cc\uae30\uae30 \ubcf5\ud569 \uc784\uc0c1 \ub2e8\uc77c \uc2e0\uccad \ud5c8\uc6a9 \ub4f1)<\/li>
            • AI\ubc95(AI Act)\uacfc\uc758 \uc0c1\ud638\uad00\uacc4 \uba85\ud655\ud654 \u2014 \uad00\ub828 \uac00\uc774\ub358\uc2a4 MDCG 2025-6 \ubc1c\ud45c (2025\ub144 6\uc6d4)<\/li><\/ul><\/li><\/ul>

              \uc8fc\uc694 \ud575\uc2ec \uc694\uad6c\uc0ac\ud56d<\/span><\/h2>

              \ud604\uc7ac \uae30\uc5c5\ub4e4\uc774 \uc2e4\ubb34\uc801\uc73c\ub85c \uac00\uc7a5 \uc9d1\uc911\ud558\uace0 \uc788\ub294 3\uac00\uc9c0 \uc694\uc18c \uc785\ub2c8\ub2e4.

              1. \uc784\uc0c1 \ud3c9\uac00 (Clinical Evaluation)<\/span><\/i><\/span><\/span>
              MDR\uc740 \u2018\ub3d9\ub4f1\uc131\u2019 \uc778\uc815 \ubc94\uc704\ub97c \ub9e4\uc6b0 \uc881\uac8c \uc81c\ud55c\ud558\uba70, \ud2b9\ud788 Class III\ubc0f \uc774\uc2dd\ud615 \uae30\uae30\ub294 \ub3d9\ub4f1\uc131 \uacbd\ub85c \uc801\uc6a9\uc774 \uc0ac\uc2e4\uc0c1 \ubd88\uac00\ud569\ub2c8\ub2e4.
              \ub530\ub77c\uc11c <\/span>CER(Clinical Evaluation Report)<\/span> \uc791\uc131\uacfc \uc790\uccb4\uc801\uc778 \uc784\uc0c1 \ub370\uc774\ud130(Clinical Data) \ud655\ubcf4, \uadf8\ub9ac\uace0 <\/span>PMCF(Post-Market Clinical Follow-up)<\/span>
              \uacc4\ud68d\uc774 \ud544\uc218\uc801\uc785\ub2c8\ub2e4.<\/span><\/p><\/div><\/div>

               2.GSPR (General Safety and Performance Requirements)<\/i><\/span><\/div>

              MDD\uc758 \ud544\uc218 \uc694\uad6c\uc0ac\ud56d(ER)\uc774 MDR\uc758 GSPR\ub85c \ub300\uccb4\ub418\uc5c8\uc2b5\ub2c8\ub2e4. \ub354 \uc138\ubd84\ud654\ub41c \uc548\uc804 \ubc0f \uc131\ub2a5 \uae30\uc900\uc744 \ucda9\uc871\ud574\uc57c \ud558\uba70, \ud2b9\ud788 \uc18c\ud504\ud2b8\uc6e8\uc5b4(MDSW) \ubc0f
              \ud654\ud559\uc801 \uc548\uc804\uc131 \uae30\uc900\uc774 \uac15\ud654\ub418\uc5c8\uc2b5\ub2c8\ub2e4.<\/p>

              3.UDI \ubc0f EUDAMED<\/i><\/span><\/div>
                • UDI(Unique Device Identification):<\/span> \ubaa8\ub4e0 \uc758\ub8cc\uae30\uae30\uc5d0 \uace0\uc720\uc2dd\ubcc4\ucf54\ub4dc\ub97c \ubd80\uc5ec\ud558\uace0 \ub77c\ubca8\uc5d0 \ubd80\ucc29\ud574\uc57c \ud569\ub2c8\ub2e4<\/span><\/li>
                • EUDAMED:<\/span> \uc720\ub7fd \uc758\ub8cc\uae30\uae30 \ub370\uc774\ud130\ubca0\uc774\uc2a4\uc785\ub2c8\ub2e4. 6\uac1c \ubaa8\ub4c8 \uc911 4\uac1c \ubaa8\ub4c8(\uacbd\uc81c \uc8fc\uccb4 \ub4f1\ub85d, UDI\/\uae30\uae30 \ub4f1\ub85d, \uc778\uc99d\uae30\uad00 \ubc0f \uc778\uc99d\uc11c, \uc2dc\uc7a5 \uac10\uc2dc)\uc758
                  \uae30\ub2a5\uc774 \ud655\uc778\ub418\uc5b4 2026\ub144 5\uc6d4 28\uc77c\ubd80\ud130 \uc758\ubb34 \uc0ac\uc6a9\uc774 \uac1c\uc2dc<\/span>\ub429\ub2c8\ub2e4. \ud604\uc7ac Actor \ub4f1\ub85d \ubc0f UDI\/\uae30\uae30 \ub4f1\ub85d \ubaa8\ub4c8 \uc0ac\uc6a9\uc774 \uad8c\uc7a5\ub429\ub2c8\ub2e4.<\/span><\/li><\/ul><\/li><\/ul>

                  \uc778\uc99d\uc808\ucc28<\/span><\/h2>

                  \uc81c\ud488\ubcc4 \uc694\uad6c\uc0ac\ud56d \ud655\uc778 \u2192 \uc81c\ud488 \uc2dc\ud5d8 \u2192 \uae30\uc220\ubb38\uc11c \uc791\uc131 \u2192 \ud544\uc694 \uc2dc \uc778\uc99d\uae30\uad00(Notified Body)\uc744 \ud1b5\ud574 \uc778\uc99d \u2192 CE \ub9c8\ud06c \ubd80\ucc29<\/p>

                  \uc778\uc99d\ud6a8\uacfc<\/span><\/h2>
                    • \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>
                    • EU \ud68c\uc6d0\uad6d \uc218\ucd9c\uc5d0 \uc81c\ud55c\uc774 \uc5c6\uc74c (EU \ud68c\uc6d0\uad6d \ub0b4 \ubaa8\ub4e0 \uc81c\ud488\uc5d0 CE Mark \uc758\ubb34\ud654)<\/li>
                    • EU \uc774\uc678\uc758 \uad6d\uac00 \uc218\ucd9c \uc2dc\uc5d0\ub3c4 \uc218\ucd9c\uacbd\uc7c1\ub825 \uac15\ud654<\/li>
                    • \uc81c\ud488\uc758 \uc548\uc804\uc131 \uc785\uc99d\uc744 \ud1b5\ud55c \uc18c\uc1a1 \uc704\ud5d8 \uac10\uc18c<\/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><\/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
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                      \n\t\t\t\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
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                      \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
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                      \n

                      <\/p>

                        <\/ul><\/div>\n
                        \n
                        \n<\/fieldset>\n