MDR在注冊時,需要提交的的文件很多,很多小伙伴可能在準(zhǔn)備時不知所向,而浪費(fèi)了很多的時間。
今天小編就根據(jù)MDR法規(guī)及MEDDEV 2.7/1 rev.4的要求,建議在遞交臨床資料時,提交以下資料,一定要收藏觀看哦!
一:Executive summary(option)----摘要(選項)
二:Declaration of conformity-----符合性聲明
三:Device description------器械描述
四:Technical specification-----技術(shù)規(guī)范
五:Previous and similar generation-----以前的或類似器械的引用
六:Labels and IFU(Instruction for use)----標(biāo)簽和使用說明書
七:GSPR(General Safety &Performance Requirements) checklist---通過安全和性能要求清單
八:List of standards---標(biāo)準(zhǔn)/法規(guī)清單----包含歐盟協(xié)調(diào)標(biāo)準(zhǔn)
九:Benefit-risk analysis and risk management----收益-風(fēng)險分析和風(fēng)險管理
十:Description of the design---設(shè)計說明
十一:Production V&V*生產(chǎn)相關(guān)(選項)
(1)Electricel safety-電氣安全
(2)Electromagnetic compatibility-電磁兼容
(3)Mechanical safety-機(jī)械安全
(4)Reliability and lifetime-可靠性和奉命
(5)Diagnostic device with measuring function-具有診斷和測試功能的器械
(6)Combination with other device-與其連接的器械
(7)Human factor and usability-人的因素和可用性(非專業(yè) 人員使用)
(8)Software verification & validation-軟件驗證&確認(rèn)
(9)Other pre-clinical test; device specific bench test-其他臨床前測試;設(shè)備特定貨架試驗
(10)Bioburden and sterilization-微生物污染水平和滅菌
(11)Packaging qualification and shelf life-包裝質(zhì)量和保質(zhì)期
(12)Packaging testing for handing and transport-搬運(yùn)和運(yùn)輸?shù)陌b試驗
(13)Hygienic reprocessing device-器械的重復(fù)使用衛(wèi)生處理
(14)Biological evaluation-生物學(xué)評價
(15)Other pre-clinical test; in-vitro/animal studies-其他臨床前測試;體外試驗和動物實驗
(16)Clinical Evaluation-臨床評價
(17)SSCP(Summary of Safety and Clinical Performance)-全安性和臨床性能總結(jié)
(18)Implant card-植入物卡
(19)Medicinal product-含有藥物產(chǎn)品(藥械組合)
(20)Tissue or cells of animal or human ongin-動物源或人源的組織或細(xì)胞
(21)Absorbed or locally dispersed substances-可吸收或局部擴(kuò)散的特質(zhì)
(22)CMR or endocrine disruptive substances-含有CMR(致癌、致突變或生物毒性)或內(nèi)分泌物質(zhì)的器械
(23)Disposal consideration-處置考量
十二:Description of manufacturing process and their validation and QC-制造過程的描述及其驗證和質(zhì)量控制
十三:Post-market surveillance(PMS)-上市后監(jiān)督
十四:Installation,repair&service,and maintenance-安裝,維修&服務(wù),維護(hù)
十五:Design change records(option)-設(shè)計更改記錄