1、Clinic Evaluation Report Page PAGE 14 of 15 1/14文件類別和屬性上層文件質(zhì)量手冊文件屬性程序文件模塊屬性MDD維護(hù)部門研發(fā)部文件編號QP-23版 本臨床資料匯編程序擬制審核批準(zhǔn)日期日期日期文 件 修 訂 履 歷修訂狀態(tài)修訂內(nèi)容概述修訂人批準(zhǔn)人修訂日期發(fā)至綜合部采購部市場部研發(fā)部質(zhì)量部生產(chǎn)部由:綜合部目的按照MDD標(biāo)準(zhǔn)要求,規(guī)定了醫(yī)療器械在投放市場前,為保護(hù)人體安全和確保科學(xué)性的前提下,通過臨床調(diào)查收集資料或收集有關(guān)科學(xué)文獻(xiàn),評價醫(yī)療器械在正常條件下,是否符合預(yù)期安全性設(shè)想和預(yù)期結(jié)果,并形成文件,以決定該醫(yī)療器械能否進(jìn)入市場程序要求。適用范圍:適用于

2、所有醫(yī)療器械。術(shù)語與定義無職責(zé)和權(quán)限質(zhì)量部組織確定施臨床研究的單位，按照本文件規(guī)定和有關(guān)法規(guī)的要求組織臨床調(diào)查和臨床資料匯編工作。工作程序醫(yī)療器械臨床調(diào)查臨床調(diào)查達(dá)到的目的證明在正常使用條件下,器械的使用情況與MDD等適用條款規(guī)定的內(nèi)容相適應(yīng)及符合。確定在正常使用條件下,沒有任何不希望有的副作用,并根據(jù)器械的預(yù)期用途對其可接受的風(fēng)險進(jìn)行評價。驗證產(chǎn)品功能和特性是否達(dá)到設(shè)計要求。有下列情況發(fā)生時,必須進(jìn)行臨床調(diào)查a) 完全新型的醫(yī)療器械,其部件,特性,作用方式都是不可知的;b) 類醫(yī)療器械;c) 對現(xiàn)有器械作了修改,其修改可能明顯地影響了完全性和性能;d) 現(xiàn)有器械用于新的適應(yīng)癥;e) 新材料與

3、身體接觸;f) 使用相當(dāng)長時間的器械g) 植入式長期創(chuàng)傷性a類或b類醫(yī)療器械;等等。臨床調(diào)查方法必須在反映最新科學(xué)技術(shù)知識,在適當(dāng)?shù)恼{(diào)查方案和其他文件基礎(chǔ)上實施,為確保結(jié)論有科學(xué)依據(jù),應(yīng)包括以下內(nèi)容：a) 器械的預(yù)期用途和正常使用條件;b) 器械的安全性,作用,副作用和不良效果;c) 評價使用該器械治療對患者的益處和可能的危害。臨床調(diào)查應(yīng)在國家指定的醫(yī)療機構(gòu)進(jìn)行,并且至少選擇二家。由醫(yī)院出具臨床試驗報告。臨床試驗報告必須有試驗人員的簽名、醫(yī)院的簽署意見和蓋章。臨床調(diào)查必須在醫(yī)療器械要求的正常使用條件下進(jìn)行。醫(yī)療器械所有的安全性和有效性都必須進(jìn)行臨床檢驗。對于所有不利的事故必須做出完整的記錄,由

4、管理者代表部通知主管當(dāng)局。臨床資料的收集與評估由研發(fā)工程部組織收集對該醫(yī)療器械預(yù)期用途有利用價值的近期有關(guān)科學(xué)文獻(xiàn)（臨床文獻(xiàn)）資料出版物,以及有關(guān)記錄資料等,資料應(yīng)按以下內(nèi)容組織,并附于相關(guān)技術(shù)文件,以證實其符合基本要求：a) 器械的預(yù)期用途;b) 實現(xiàn)器械預(yù)期用途的技術(shù);c) 器械的作用,副作用和不良效果,等等。研發(fā)工程部對所收集的臨床文獻(xiàn)資料進(jìn)行嚴(yán)格評估形成匯總報告,匯總報告應(yīng)包含以下內(nèi)容：a) 為降低風(fēng)險而采取的技術(shù)和管理上的措施;b) 采用該器械治療對患者的益處和可能的危害的對比; c) 關(guān)于引用的科學(xué)論文等等。臨床資料的匯編與控制匯編資料包括：a) 臨床調(diào)查資料b) 臨床試驗報告c)

5、 收集的臨床文獻(xiàn)資料d) 臨床資料評估匯總報告質(zhì)量法規(guī)部對收集的臨床調(diào)查資料、臨床文獻(xiàn)資料和編寫的臨床資料評估報告進(jìn)行整理、匯編成臨床評估報告應(yīng)包括如下內(nèi)容：a) 患者,醫(yī)護(hù)人員和第三方的風(fēng)險和適當(dāng)?shù)陌踩胧゜) 一個風(fēng)險/利益的評估,所存在的風(fēng)險必須在可接受的范圍內(nèi)c) 對同類產(chǎn)品所發(fā)表的文獻(xiàn)的匯總并給出參考文獻(xiàn)的清單d) 臨床前結(jié)果及市場反饋信息臨床評估報告作為CE技術(shù)文件按標(biāo)簽語言和說明書控制程序的要求進(jìn)行控制。參考文件標(biāo)簽語言與技術(shù)文件編寫指南MEDDEV2.7.1ISO13485：2003+AC2007醫(yī)療器械的專用標(biāo)準(zhǔn)要求。記錄文獻(xiàn)收集報告 QR-QP-23-01臨床評估報告 QR

6、-QP-23-02 CONFIDENTIALDocument No.: Version:Development DocumentQR-QP-23-01RevA1Total Pages:7Project name:XXXX SUBJECT * MERGEFORMAT Document name:The literature search report Written: Auditor: Approved: Date:Date:Date:Revision RecordVer.Revision descriptionRevisorDateTable of Contents TOC o 1-3 h z

7、 HYPERLINK l _Toc326159185 Table of Contents PAGEREF _Toc326159185 h 2 HYPERLINK l _Toc326159186 Chapter1 Summary PAGEREF _Toc326159186 h 3 HYPERLINK l _Toc326159187 Chapter2 Scope of the literature search PAGEREF _Toc326159187 h 4 HYPERLINK l _Toc326159188 Chapter3 Methods of the literature search

8、PAGEREF _Toc326159188 h 5 HYPERLINK l _Toc326159189 3.1Date of search PAGEREF _Toc326159189 h 5 HYPERLINK l _Toc326159190 3.2Name of person(s) undertaking the literature search: PAGEREF _Toc326159190 h 5 HYPERLINK l _Toc326159191 3.3Period covered by search PAGEREF _Toc326159191 h 5 HYPERLINK l _Toc

9、326159192 3.4Literature sources used to identify data PAGEREF _Toc326159192 h 5 HYPERLINK l _Toc326159193 3.5Database search details PAGEREF _Toc326159193 h 5 HYPERLINK l _Toc326159194 3.6Selection criteria used to choose articles PAGEREF _Toc326159194 h 5 HYPERLINK l _Toc326159195 3.7Have same or s

10、imilar principles and structural features PAGEREF _Toc326159195 h 5 HYPERLINK l _Toc326159196 Chapter4 Outputs of the literature search PAGEREF _Toc326159196 h 6 HYPERLINK l _Toc326159197 4.1Attach copy of literature citations retrieved from each database search PAGEREF _Toc326159197 h 6 HYPERLINK l

11、 _Toc326159198 4.2Data selection process PAGEREF _Toc326159198 h 7SummaryEC Certificate Registration No.Legal ManufacturerProduct groupUMDNS NumberProduct Name(s)& modelClassification RuleClassProcedure for CertificationNotified BodyScope of the literature searchAccording to the XXX Intended use,the

12、 scope of the literature search is as follows:Methods of the literature searchDate of search Name of person(s) undertaking the literature search: Period covered by searchLiterature sources used to identify dataDatabase search detailsSelection criteria used to choose articlesHave same or similar prin

13、ciples and structural featuresHave same or similar performance.Have same or similar intended use and intended purpose.Used for the same or similar clinical condition or purpose, used at the same site in the body, used in similar population.Outputs of the literature searchAttach copy of literature ci

14、tations retrieved from each database search The related clinical literatures identified through the evaluation of the products of the other companies which are registeredNumberName of literatureSourceData selection processFlow chart of data selection process Potentially relevant literature identifie

15、d through the search 搜索到的可能與待評估的醫(yī)療設(shè)備相關(guān)的文獻(xiàn) Literature excluded, with reasons Literature retrieved for more detailed assessment assessment Literature excluded from clinical evaluation, with reasons evaluation, with reasons Literature with relevant useable data included in the clinical evaluation, by o

16、utcome: Device performance and safety.Associated tables showing how all citations were assessed for for inclusion in the clinical evaluationNumberName of literatureSourceComments/ObservationComplianceYes No N/A1 23456789CONFIDENTIALDocument No.: Version:Development DocumentQR-QP-23-02RevA0Total Page

17、s:15Project name:XXXX SUBJECT * MERGEFORMAT Document name:Clinic Evaluation ReportWritten: Auditor: Approved: DateDate:Date:Revision RecordVer.Revision descriptionRevisorDateTable of Contents TOC o 1-3 h z HYPERLINK l _Toc327863495 Table of Contents PAGEREF _Toc327863495 h 2 HYPERLINK l _Toc32786349

18、6 Chapter1 Product information PAGEREF _Toc327863496 h 3 HYPERLINK l _Toc327863497 Chapter2 Description of the device PAGEREF _Toc327863497 h 4 HYPERLINK l _Toc327863498 2.1Principle PAGEREF _Toc327863498 h 4 HYPERLINK l _Toc327863499 2.2structure PAGEREF _Toc327863499 h 4 HYPERLINK l _Toc327863500

19、2.3material PAGEREF _Toc327863500 h 6 HYPERLINK l _Toc327863501 2.4Intended Use PAGEREF _Toc327863501 h 7 HYPERLINK l _Toc327863502 2.5Technical data PAGEREF _Toc327863502 h 8 HYPERLINK l _Toc327863503 2.6Warning: PAGEREF _Toc327863503 h 8 HYPERLINK l _Toc327863504 Chapter3 Choice of clinical data t

20、ypes PAGEREF _Toc327863504 h 9 HYPERLINK l _Toc327863505 3.1Clinical route selection PAGEREF _Toc327863505 h 9 HYPERLINK l _Toc327863506 3.1.1Data generated through literature search PAGEREF _Toc327863506 h 9 HYPERLINK l _Toc327863507 3.1.2Data generated through clinical experience PAGEREF _Toc32786

21、3507 h 9 HYPERLINK l _Toc327863508 3.2Comparative points of the literature PAGEREF _Toc327863508 h 9 HYPERLINK l _Toc327863509 Chapter4 Summary of the clinical data &appraisal PAGEREF _Toc327863509 h 11 HYPERLINK l _Toc327863510 4.1the comparison of Unimed sensor with the similar product PAGEREF _To

22、c327863510 h 11 HYPERLINK l _Toc327863511 4.2Clinical risk analysis and control measure PAGEREF _Toc327863511 h 12 HYPERLINK l _Toc327863512 4.3The clinical trial data of Unimed Spo2 sensor PAGEREF _Toc327863512 h 12 HYPERLINK l _Toc327863513 Chapter5 Conclusion PAGEREF _Toc327863513 h 15Product inf

23、ormationEC Certificate Registration No.Legal ManufacturerProduct groupUMDNS NumberProduct Name(s)& modelClassification RuleClassProcedure for CertificationNotified Body Description of the device Principlestructurethe sensor structure chartModelDrawingmaterialTable Description of Biocompatibility abo

24、ut material contact with skinModelStructureMaterialTesting report numberRemarkIntended UseTechnical data1).Performance/Reliability2).Safety:3) Compatibility:4) Storage/PackagingWarning:Choice of clinical data typesClinical route selection Data generated through literature search According to the “GU

25、IDELINES ON MEDICAL DEVICES CLINICAL EVALUATION:A GUIDE FOR MANUFACTURERS AND NOTIFIEDBODIES”, Unimed sensor it can come to the clinical evaluation through by literature search. We search the literature about the clinical relative of the Unimed sensor and the similar product through the literature s

26、earch. Compare the Unimed sensor with the similar product of other companies in the principle, structure, performance, and clinical application. And then prove the Unimed sensor is substantive equivalent with the similar product of other companies.The content of the related clinical literatures are

27、selected for Unimed sensor clinical evaluation should meet one of the following points:Have same or similar principles and structural featuresHave same or similar performance.Have same or similar intended use and intended purpose.Used for the same or similar clinical condition or purpose, used at th

28、e same site in the body, used in similar population.Data generated through clinical experienceComparative points of the literatureNumberName of literatureSourceCommentSummary of the clinical data &appraisalthe comparison ofXXXX with the similar product The following is the comparison table of the XX

29、XXwith the similar product of other companies which have registered in the principle, structure, performance, application. Table 1：Comparison table of the XXXX with the similar product which have obtained CEmarkItemXXXX XXXXComparison ManufacturerCEMark. classificationprincipleApplication scope stru

30、ctureMeasurement Part PerformanceStandard metIntended useApplication conclusionThrough the comparison table, we believe that our Unimed sensor is substantive equivalent with the similar product of other companies which are registered in principle, structure, performance, application and so on.Clinical risk analysis and control measureThe possible potential hazards in the process of the clinical application are: Control measures: prepare a detailed directions for Use enable the user to understand th