비의료 목적 기기의 규제 접근법: 유럽과 한국의 비교
Regulatory Approaches to Non-Medical Purpose Devices: Europe vs. Korea
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초록
The EU regulates devices without an intended medical purpose under Annex XVI of the Medical Device Regulation (MDR, EU 2017/745) and enforces additional requirements through Common Specifications (CS). Korea, however, lacks an independent framework and evaluates such devices based on equivalence with approved medical devices. This study compares the European and Korean regulatory approaches and proposes a documentation review strategy for CE certification. Requirements of MDR Annex XVI and CS were analyzed and compared with Korea’s current procedures. Key elements for technical documentation were identified. Europe provides clear classification and requirements, while Korea’s reliance on equivalence creates regulatory ambiguity. For CE certification, Korean manufacturers need clinical evaluation with post-marketing data, establishment and documentation of risk management system reflecting CS. The proposed strategy offers practical guidance for CE certification and highlights the need for Korea to establish a dedicated framework aligned with international standards.
Abstract
The EU regulates devices without an intended medical purpose under Annex XVI of the Medical Device Regulation (MDR, EU 2017/745) and enforces additional requirements through Common Specifications (CS). Korea, however, lacks an independent framework and evaluates such devices based on equivalence with approved medical devices. This study compares the European and Korean regulatory approaches and proposes a documentation review strategy for CE certification. Requirements of MDR Annex XVI and CS were analyzed and compared with Korea’s current procedures. Key elements for technical documentation were identified. Europe provides clear classification and requirements, while Korea’s reliance on equivalence creates regulatory ambiguity. For CE certification, Korean manufacturers need clinical evaluation with post-marketing data, establishment and documentation of risk management system reflecting CS. The proposed strategy offers practical guidance for CE certification and highlights the need for Korea to establish a dedicated framework aligned with international standards.