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MDCG 2024-7 Rev.1MDCG 2024-7 Annex  mdcg_2024-7_en_0.docx https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fhealth.ec.europa.eu%2Fdocument%2Fdownload%2F939cc0b8-8db5-4b0d-b2b7-a15a98a44cbd_en%3Ffilename%3Dmdcg_2024-7_en_0.docx&wdOrigin=BROWSELINK인터넷 홈에서 파일을 검색하는 동안 잠시 기다려 주세요.view.officeapps.live.com

INTRODUCTION  This guidance document is intended for conformity assessment bodies (CABs), notified bodies (NBs), designating authorities (DAs), and Joint Assessment Teams (JATs) involved in Regulation (EU) 2017/745 on medical devices (hereafter MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (hereafter IVDR). It should be read in conjunction with the guidance document MD..

미 FDA에서 510(k) 허가를 위한 서류 제출방식 가이던스를 발간하였다. ▶ 적용시점 FDA is identifying October 1, 2023 as the date on which the 510(k) electronic submission requirements will take effect. ▶ Scope This guidance describes the technical standards associated with preparation of the electronic submission template for 510(k)s that enable submission of the 510(k) electronic submission solely in electronic format. The el..