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...
The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations.Legally non-binding guidance documents, adopted by the medical device coordination group (MDCG) in accordance with Artic
2022年5月,欧盟委员会(EC)公布了医疗器械协调小组(MDCG)“MDCG 2022-6 IVDR第110(3)条过渡条款下的重大变更指南”(MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR)。 该指南的目的是澄清IVDR第110(3)条中“设计和预期用途的重大变更”...
Guidance on PMCF evaluation PMCF 评价报告模 April 2020 report template 板的指南 MDCG 2020-7 Guidance on PMCF plan temp PMCF 计划模板的 April 2020 late 指南 MDCG 2020-6 Guidance on sufficient clinical 遗留器械充分临床 April 2020 evidence forlegacy devices 证据的指南 MDCG 2020-5 Guidance on cl...
Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation (EU) 920/2013 May 2020 This document has been endorsed ...
2020年11月21日 2020年6月,MDCG 发布了MDCG 2020-12 Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured usingtra...
https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2020_6_guidance_sufficient_clinical_evidence_en.pdf https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en.pdf ...
2022年5月,欧盟委员会(EC)公布了医疗器械协调小组(MDCG)“MDCG 2022-6 IVDR第110(3)条过渡条款下的重大变更指南”(MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR)。 该指南的目的是澄清IVDR第110(3)条中“设计和预期用途的重大变更”...
关于本文 本文标题:MDCG 2020-5 Guidance on clinical uation – Equivalence 临床评价-等效性 中文.docx 链接地址:https://www.mayiwenku.com/p-32442824.html当前资源信息 亦亦亦 编号: 20220217183458333 类型: 共享资源 格式: DOCX 大小: 32.57KB 上传时间: 2022-02-17...
临床评价等同性指南：MDCG 2020-5 md_mdcg_2020_5_guidance_clinical_evaluation_equivalence https:/...