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유럽 의료기기 CE MDR
[CE] Classification of medical devices
- 관리자
- 2016-08-01 19:16:00
- hit2437
- 112.161.21.76
*General Requirement
All devices must:
- meet the essential requirements irrespective of the class of the device.
- be subject to the reporting requirements under the medical device vigilance system;
- be CE marked (except custom-made devices and devices intended for clinical investigation).
*Conformity Assessment
*Classification
- Non-invasive devices : 인체 비삽입 의료기기 -> Rule 1, 2, 2, 4
- Invasive devices : 인체 삽입 의료기기 -> Rule 5, 6, 7, 8
- Active devices : 능동 의료기기 -> 9, 10, 11, 12
- Special Rules :특별 규칙 -> 13, 14, 15, 16, 17, 18
All devices must:
- meet the essential requirements irrespective of the class of the device.
- be subject to the reporting requirements under the medical device vigilance system;
- be CE marked (except custom-made devices and devices intended for clinical investigation).
*Conformity Assessment
*Classification
- Non-invasive devices : 인체 비삽입 의료기기 -> Rule 1, 2, 2, 4
- Invasive devices : 인체 삽입 의료기기 -> Rule 5, 6, 7, 8
- Active devices : 능동 의료기기 -> 9, 10, 11, 12
- Special Rules :특별 규칙 -> 13, 14, 15, 16, 17, 18
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