医疗器械 医疗器械协调小组文件 MDCG202124 MDCG2021-24 医疗器械分类指南 2021.10 本文件已得到2017/745年法规(EU)第103条规定的医疗器械协调小组(MDCG)的认可。MDCG由所有成员国的代表组成,并由欧洲委员会的一 名代表担任主席。 该文件不是欧洲委员会的文件,也不能被认为反映了欧洲委员会的官方立场。本文件中...
//ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2019_9_sscp_en.pdf 6 Medical Devices Medical Device Coordination Group Document MDCG 2021- 24 However, if the healthcare provider does not have access to the higher level of packaging, the UDI carrier must appear on the ...
Guidance Classification Classification of medical devices under the MDR (MDCG 2021-24) ec.europa.eu/health/sys Guidance Classification Classification Rules for IVDs under the IVDR (MDCG 2020-16) health.ec.europa.eu/lat Manual Classification Manual on borderline and classification for medical devices ...
在这种情况下,报告类型为“最终(不可报告)事件”的MIR不应提交给相关主管当局。 https://health.ec.europa.eu/system/files/2023-02/mdcg_2023-3_en_0.pdf——官方链接 产品方案 |医用胶原蛋白类产品国内注册检验要点 国内NMPA医用内窥镜注册 印度尼西亚MOH医疗器械注册 深圳华通威国际检验有限公司 中检华通威国...
https://ec.europa.eu/health/md_sector/new_regulations/guidance_en 这个网站都是MDCG的指南 ...
Medical Device Medical Device Coordination Group Document MDCG 2019-16 rev. 1 MDCG 2019-16 Guidance on Cybersecurity for medical devices December 2019 July 2020 rev.1 This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) ...
https://single-market-economy.ec.europa.eu/single-market/goods/new-legislative-framework_en. Page4of27 MedicalDevices MedicalDeviceCoordinationGroupDocumentMDCG2021-5Rev.1 bydesignatedEuropeanstandardisationorganisationsonthebasisofspecificstandardisation requests(formerlyknownas“mandates”)issuedbytheCommission....
Current consolidated version: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02012R1025 4 Medical Devices Medical Device Coordination Group Document MDCG 2021-5 Rulings of the Court of Justice of the European Union issued in specific cases11 relevant for the whole EU ...
15. MDCG2019-11 15 MedicalDevices 医疗器械 MedicalDeviceCoordination GroupDocument MDCG2021-24 医疗器械协调小组文件 https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2019_11_guidance_qualification_classifica tion_software_en.pdf 16. MDRAnnexVIII2.4 17. MDRAnnexVIII2.5 18....
收藏次数:0 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 neede...