Thisdocumentaimstoprovideguidanceondifferentaspectsrelatedtostandardsinthemedical devicessectorinsupportoftherequirementslaiddownintheapplicableEUlegislation,taking intoaccountitsspecificities. Thecontentsofthisdocument: 1.EUlegislationonmedicaldeviceswithinthe“NewApproach”andthe“New ...
Annex II to this guidance provides a flowchart to help determine whether an IVD is a CDx. 新增: 1)对于定义为CDx的器械,应链接到具有国际非专利名称(INN)的药品。 2)用于确定特定药物剂量的定量或定性特定标志物的器械,对于已具...
Section F. Reference to any applicable common specification(s), harmonized standard(s) or applicable guidance document(s) ... 11 Section G. – Estimated date of the PMCF evaluation report ... 12 第4页 Medical Device Medical Device Coordination ...
If reference is made to the “state of the art”, that statement should be supported for example by referring to relevant recognised guidance documents generated by specialty medical societies or educational bodies. 如果提及“最新医疗技术”,则该宣称需要得到相应支持,例如参考专业医学会或教育机构编制的...
guidance. It also has to take into account the intended clinical benefits to patients with relevant and specified clinical outcome parameters as well as an indicative list and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of ...
MDCG 2020-7_guidance_pmcf_plan_template_en
MDCG guidance and the MDR, the MDR shall take precedence. 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 ...
MedicalDevices 医疗器械 MedicalDeviceCoordination GroupDocument MDCG2019-16Rev.1 医疗器械协调小组文件 MDCG2019- 16Rev.1 GuidanceonCybersecurity formedical devices 医疗器械网络安全指南 December2019 2019.12 July 2020rev.1 2020年7 月rev . 1 This document has been endorsed by the Medical Device Coordina...
By following the template and guidance provided in this document。manufacturers XXX. Medical Device n Group Document MDCG 2020-7 n The Medical Device n Group (MDCG) has released the MDCG 2020-7 document。which provides guidance on post-market clinical follow-up plans for medical devices。This...
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