mdcg_2020-2 rev1 第一类过渡条款 第120(3和4)章.pdf,Medical Device Medical Device Coordination Group Document MDCG 2020-2 rev.1 MDCG 2020-2 rev. 1 Class I Transitional provisions under Article 120 (3 and 4) – (MDR) March 2020 July 2020 rev.1 This docume
MDCG 2020-2中实施的变更是指根据旧的医疗器械指令(MDD, 93/42/EEC)在2021年5月26日之前合法投放市场的I类产品。第120条第3款现在允许将过渡期延长至2024年5月26日,并允许货物供应至2025年5月26日。本法规适用于Ir类产品,即可重复使用的外科器械或MDD I类器械(无测量功能,非无菌,这些器械在MDR下风险类别...
TheMDRrequires that technical, biological and clinical characteristics are considered when demonstrating equivalence to another device. Whilst these general characteristics are described in the MEDDEV 2.7/1 rev. 4 Appendix 1 and are aligned with the MDR requirement, there are differences in the criteria...
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...
中英文对照 MDCG-2020-1 医疗器械软件的临床评价MDR 性能评价IVDR指南.pdf,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) ofMedi
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
世界卫生组织(WHO)于2020年3月12日宣布COVID-19爆发。感染SARS-CoV-2病毒并发展成急性、严重呼吸道症状的患者必须使用呼吸机进行治疗,以保证存活的可能性。 This guidance document focuses on ventilators and related accessories that are currently ...
MDCG 2020-16 rev.2 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 February 2023 更新属于轻微修订,主要涉及到规则1(Rule 1)的示例、新增伴随诊断(Companion Diagnostics)CDx分类依据和分类路径等。
April 2020 This document has been endorsed by the Medical Device Coordination Group (MDCG) established 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 ...
2/2MDCG2020-3Rev.1|欧盟更新医疗器械重大变更指南文件 2023-05-1717:21MDCG2020-3 重大变更指南 2023年5月12日,欧盟发布了MDCG2020-3Rev.1:MDRArticle120下MDD或AIMDD证书所涵盖器械的过渡条款的重大变更指南文件。 欧盟委员会对整个文件进行调整,以使其符合法规(EU)2023/607和指南MDCG2022-2,旨在澄清MDRArtic...