MDR Art 120(3) 变更程序
2021-06-26 16:42:38 0 举报
适用于MDR Article 120(3)
作者其他创作
大纲/内容
否NO
C3
预期通途的扩展或改变Extension or change of theIntended Purpose?
这是重大变化The changeisconsideredsignificantper MDR Art. 120(3)
无重大变化The change is considered a non-significant change per MDR Art. 120(3)
是Yes
B3
如果不显着If non-significant
包装或灭菌方式变更FromMain Chart: Change of terminal sterilization method of device or packaging design with impact to the sterilisation?
B2
D4
E2
新的风险是否受控，或现有风险是否受影响Do new risks require control measures or are existing risks negativelyaffected
回到主程序（问题D）Return toMain Chart QuestionD
程序AChart A
新的用户或适应群体New user or patient population?
最终灭菌方法变更Change* of terminal sterilization method?
影响或改变无菌保证**的设计变更？Design Change which affects or changes the sterility assurance**?
新供应商的原材料是否符合标准Ingredient ormaterial from newsuppliermeetsexisting specification?
D3
所需的用户输入被闭环算法取代？Required user input replaced by closed loop algorithm?
C6
预期用途发生变更Change of theIntended Purpose?
软件变更FromMain Chart: Software change?
回到主程序（问题X）Return toMain Chart QuestionX
医疗器械在MDR法规下发生变更Change of an existing Medical Devicecertified under MDD or AIMDD
进入程序BChange tobeassessedin accwithChart B
微小变化Minor Change*?
程序EChart E
C4
程序CChart C
回到主程序（问题E）Return toMain Chart QuestionE
回到主程序（问题C）span style=\"font-size: inherit;\
B
经过公告机构批准并验证的货架寿命的变更Shelf-life change validated by protocols approved by the notified body***?
与纠正措施相关的设计变更Design change related to corrective actions*?
更改设计或与性能有关的规格Change of the design or performance specification?
D1
程序BChart B
D2
材料变更Change of aMaterial*?
变更是否需要进一步的临床或可用性数据来支持安全性和性能Does the change require further clinical or usability data to supportsafety and performance? **
A4
操作系统或任何组件有新增或重大变化？New or major change of operating system or any component?
程序DChart D
包装或灭菌方式变更Change of terminal sterilization method of device or packaging design with impact to the sterilisation?
A
E1
C
D
A3
材料变更FromMain Chart: Change of aMaterial*?
预期用途发生变更FromMain Chart:Change of the IntendedPurpose*
X
预期用途的限制Limitation of the Intended Purpose?
新的人机交互界面New user interface or presentation of data*?
A1
软件变更Software change?
被供应商改变成分的原材料是否符合标准Changed ingredientor material fromexisting suppliermeetsexisting specification?
更改设计或与性能有关的规格FromMain Chart: Change of theDesignorPerformance Specification*
C2
A2
更改或添加为人类/动物来源的材料Change to a material of human/animal origin including addition of new materials?
E
B1
临床用途的改变Change of clinical use**?
C1
C5
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