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1. Introduction Article 120 of the Medical Device Regulation (EU) 2017/745 (MDR), as amended by Regulation (EU) 2023/607, states that devices which are covered by valid certificates issued by a notified body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) or the Medical Devices Directive 93/42/EEC (MDD) may be placed on the market or put into service after the date of a..

Emergo by UL 에서 MDR 관련하여 최근에 발표한 Regulation (EU) 2023/607과 관련된 내용으로 웨비나를 진행한다. ▶ 일자: 2024년 01월 18일(목) 자정 (0시, CST 기준 오전 9시) ▶ 온라인으로 45분 동안 진행 예정 ▶ 링크 Regulation EU 2023/607 Frequently Found Issues | Emergo by UL Regulation EU 2023/607 Frequently Found Issues In this complimentary webinar, our Emergo by UL subject matter expert will outline the latest insights about Regulation EU 2023/607. www.em..

MDR 전환기간 동안 대상제품의 유럽시장 판매, 서비스 가능여부를 판단할 수 있는 흐름도 대상제품: Legacy device, Class III custom-made implantable devices 근거: Article 120 MDR, as ameded by Regulation 2023/607 Flowchart to assist in deciding whether or not a device is covered by the extended MDR transitional period (europa.eu) Flowchart to assist in deciding whether or not a device is covered by the extended MDR transitional period Flowc..