2.Reference documents参考文件 This document provides facilitative guidance to the requirements of MDR Chapter VI and Annex XIV, and references the following MDD/AIMDD guidance documents: 本文件为MDR第VI章和附件第XIV的要求提供了进一步指导,并参考了以下MDD/AIMDD指导文件: l MEDDEV 2.7/1 rev. 4: Clin...
as described in previous stages, demonstrate together conformity with relevant GSPR. In order to determine the benefit-risk ratio, it is necessary to identify the benefits and risks associated with the device and the alternatives (if any). Practical guidance is available in section 10 of MEDDEV...
内容提示: Medical Device Medical Device Coordination Group Document MDCG 2020-6 MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC A guide for manufacturers and notified bodies April 2020 This document...
需要金币:*** 金币(10金币=人民币1元) mdcg_2020-6 关于传统设备的充分临床证据的指导.pdf 关闭预览 想预览更多内容,点击免费在线预览全文 免费在线预览全文 Medical Device Medical Device Coordination Group Document MDCG 2020-6 MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medica...
https://ec.europa.eu/health/md_sector/new_regulations/guidance_en 这个网站都是MDCG的指南 ...
This MDCG guidance does not introduce any new requirements. The demonstration of equivalence does not remove the requirement to always conduct a clinical evaluation in accordance with the MDR. It is the demonstration of equivalence6 that allows the manufacturer to let clinical data from an equivalent...
MedicalDevices 医疗器械 MedicalDeviceCoordination GroupDocument MDCG2020-1 医疗器械协调小组文件 MDCG2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation(IVDR) ofMedicalDevice Software 医疗器械软件的临床评价 (MDR)/性能评价 (IVDR)指 南 March2020 2020.03 This document has been endorsed ...
MDCG 2020-3 重大变更和附件指南.pdf,Medical Device Medical Device Coordination Group Document MDCG 2020 - 3 MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by cer
6 Upcoming guidance on harmonised practices and technical solutions to facilitate exchange of information in absence of EUDAMED. Medical Device Medical Device Coordination Group Document MDCG 2020-2 rev.1 sterile or do not have a measuring function) that are required to have certificates after 26 ...
变更描述:编辑修改,由intended to be used 改成了 intended by the manufacturer.明确该规则适应的是制造商预设在一段时间内进行多次/连续测量的产品。 06 变更点:Annex II 变更描述:增加Annex II,判定IVD是否属于CDx的流程图 https://health.ec.europa.eu/system/files/2023-02/md_mdcg_2020_guidance_classific...