医疗器械协调组（MDCG）：2024-4 欧盟2017 746 IVDR法规下IVD 临床性能研究中的安全性报告（英文版）（23页）.pdf

1、Medical Devices Medical Device Coordination Group Document MDCG 2024-4 Page 1 of 23 MDCG 2024-4 Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation(EU)2017/746 April 2024 This document has been endorsed by the Medical Device Coordination Group(MDCG)establi

2、shed by Article 103 of Regulation(EU)2017/745.The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European

3、 Commission.Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law.Medical Devices Medical Device Coordination Group Document MDCG 2024-4 Page 2 of 23 Table of contents 1 INTRODUCTION.4 2 SCOPE.5

4、2.1 PERFORMANCE STUDIES OF IN VITRO DIAGNOSTIC MEDICAL DEVICES.5 3 ABBREVIATIONS.5 4 DEFINITIONS.6 4.1 ADVERSE DEVICE EFFECT(ADE).6 4.2 ADVERSE EVENT(AE).6 4.3 ANTICIPATED SERIOUS ADVERSE DEVICE EFFECT(ASADE).6 4.4 COMPANION DIAGNOSTIC(CDX).6 4.5 DEVICE FOR PERFORMANCE STUDY.6 4.6 DEVICE DEFICIENCY(

5、DD).6 4.7 INCIDENT.7 4.8 IN-HOUSE IVD.7 4.9 INTERVENTIONAL CLINICAL PERFORMANCE STUDY.7 4.10 INVESTIGATOR.7 4.11 LEFT-OVER SAMPLE.7 4.12 MALFUNCTION.7 4.13 MANUFACTURER.7 4.14 NEW FINDING.7 4.15 PERFORMANCE STUDY(PS).7 4.16 PERFORMANCE STUDY PLAN(PSP).7 4.17 SERIOUS ADVERSE DEVICE EFFECT(SADE).7 4.1

6、8 SERIOUS ADVERSE EVENT(SAE).8 4.19 SPECIMEN.8 4.20 SPONSOR.8 4.21 STUDY PROCEDURE.8 4.22 SUBJECT.8 4.23 UNANTICIPATED SERIOUS ADVERSE DEVICE EFFECT(USADE).8 5 REPORTING METHOD.8 5.1 REPORTABLE EVENTS IN PRE-MARKET PS INITIATED UNDER DIRECTIVES LEGISLATION.9 5.2 TRANSITION TO REPORTING VIA EUDAMED.9