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Introduction – Objectives of the MDR/IVDR amendment The amendment of the MDR and of the IVDR through Regulation (EU) 2024/1860 addresses three topics: 1. Regulation (EU) 2024/1860 aims to ensure a high level of patient safety and public health protection, including the mitigation of risks related to discontinuation or interruption of supply of in vitro diagnostic medical devices (IVDs) needed fo..

This document is intended for sponsors of clinical investigations of devices conducted within the scope of the Regulation (EU) 2017/745 (MDR). This document may be supplemented in due course with further questions and answers. Throughout this document the term ꞌdeviceꞌ is used with the same meaning as in the MDR, i.e., for the purpose of the MDR, medical devices, accessories for medical devices ..

▶ 유럽연합에서 MDR Annex XVI에 따른 의료목적이 없는 제품의 trasitional 에 따른 문의사항에 대해 Q&A 형식으로 제공 Q&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDR (europa.eu) Q&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDR Q&A on transitional provisions for products without an intended medical purpose cove..