新政策法规对IVD生产商的法律规定规定有重要更改,引进了新的根据标准的归类管理体系(rule-basedclassificationsystem),扩张了需公示组织开展审查的商品范畴。新的根据标准的归类管理体系替代了原命令中根据明细的归类管理体系(list-basedsystem)。依照新的归类标准,达到90%的IVD商品将必须公示组织开展适用性审查。
1. IVDR (EU) 2017/746 2. IEC 62304:2006 Medical device software — Software life cycle processes 3. MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR 4. Best Practice Guidance for the Submission ...
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。 1. Rule 1 示例 修改前:Highly virulent pandemic in...
IVDR 体外诊断医疗器械分类指南 MDCG2020-16rev.2 2023-02-2010:04 MDCG2020-16rev.2 GuidanceonClassificationRulesforinvitroDiagnosticMedicalDevicesunderRegulation(EU)2017/746 February2023 更新属于轻微修订,主要涉及到规则 1(Rule1)的示例、新增伴随诊断(CompanionDiagnostics)CDx 分类依据和分类路径等。 1.Rule1...
Guidance on Classification Rules forin vitroDiagnostic 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。 1....
新法规对IVD制造商的法规要求有重大改变,引入了新的基于规则的分类体系(rule-basedclassificationsystem),扩大了需公告机构进行评审的产品范围。新的基于规则的分类体系取代了原指令中基于清单的分类体系(list-basedsystem)。按照新的分类规则,高达90%的IVD产品将需要公告机构进行符合性评审。
The National Classification of Medical Devices (CND) nomenclature will be mapped to the Global Medical Device Nomenclature (GMDN) and made available in MDR Eudamed, according to the EC. “The correspondence between the nomenclatures will be visible to operators and incorporated in the future databas...
4 MedicalDevices 医疗器械 MedicalDeviceCoordination GroupDocument MDCG2020-1 医疗器械协调小组文件 Software developers shouldrefer to MDCG 2019-11for guidance on the appropriate qualification and classification of software prior to such software being introduced into the market. The same principles of ...
The National Classification of Medical Devices (CND) nomenclature will be mapped to the Global Medical Device Nomenclature (GMDN) and made available in MDR Eudamed, according to the EC. “The correspondence between the no...
IVDR体外诊断医疗器械分类指南MDCG2020-16rev.2(2023.02) MDCG2020-16rev.2 GuidanceonClassificationRulesforinvitroDiagnosticMedicalDevicesunderRegulation(EU)2017/746 February2023 更新属于轻微修订,主要涉及到规则1(Rule1)的示例、新增伴随诊断(CompanionDiagnostics)CDx分类依据和分类路径等。 1.Rule1示例 修改前:...