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[EU] Pilot coordinated assessment for CI/PS

Call for applicationsMember States, supported by the European Commission, are pleased to announce the launch of a pilot coordinated assessment of clinical investigations and performance studies across multiple Member States as per Articles 78 of the Regulation (EU) 2017/745 (MDR) and 74 of the Regulation (EU) 2017/746 (IVDR) respectively. This pilot will allow sponsors to submit a single applica..

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

SummaryThe Food and Drug Administration (FDA) is announcing a public workshop entitled “Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility of Medical Devices.” The purpose of this public workshop is for the FDA to discuss with stakeholders the expansion of the Accreditation Scheme for Conformity Assessment (ASCA) program to include chemical an..

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..

Introduction and scope This document aims to provide guidance to the authorities responsible for notified bodies (hereafter, the Designating Authorities) and joint assessment teams (JATs) when conducting: − assessments of conformity assessments bodies (CABs) that apply for designation as a notified body (NB) in the field of medical devices and/or in vitro diagnostic medical devices,− extensions ..

▶ Preliminary re-assessment review (PRAR) form template (MDR) - MDCG 2024-6▶ Preliminary assessment review (PAR) form template (MDR) - MDCG 2024-7▶ Preliminary assessment review (PAR) form template (IVDR) - MDCG 2024-8▶ Preliminary re-assessment review (PRAR) form template (IVDR) - MDCG 2024-9