醫(yī)療器械臨床評(píng)估_中英文翻譯

1、CLINICAL EVALUATION REPORT臨床評(píng)估報(bào)告For Product: XXXX產(chǎn)品： XXXXDocument No. XXXXXXXX文件編號(hào)Version: 1.0版本 :Date: 2020-01-26日期:Author:作者 :Reviewed by:審閱：Approved by:批準(zhǔn)：vCompa ny公司Table of Content目錄Page頁碼1. Gen eral details 總述 52. Descripti on of the device and its inten ded applicati on器械描述和預(yù)期用途53. Intendedth

2、erapeutic and/ordiagnosticindications and claims預(yù)期治療和/或診斷說明和要求 64. Con textof the evaluati on and choice ofcli ni caldata types評(píng)估背景和臨床數(shù)據(jù)類型的選擇 65. Summary of the clinical data and appraisal總結(jié)臨床數(shù)據(jù)和評(píng)價(jià) 86. Data an alysis數(shù)據(jù)分析 96.1. Performa nee性能9安全9產(chǎn)品文獻(xiàn)和使用說明107. Con clusi ons結(jié)論io1. General details 總述Sta

3、te the proprietary name of the device and any code names assigned duringdevice developme nt.Iden tify the manu facturer(s) of the device.描述器械的商品名，以及在器械研發(fā)過程中使用的任何編碼。識(shí)別器械的生產(chǎn)商。2. Descripti on of the device and its inten ded applicati on器械描述和預(yù)期用途Provide a con cise physical descripti on of the device, cr

4、oss referencing to releva ntsecti ons of the manu facturer' tech ni cal in formatio n as appropriate. Thedescription should cover information such as:materials, in clud ing whether it in corporates a medic inal substa nce (already on themarket or new), tissues, or blood products;the device comp

5、onen ts, in clud ing software and accessories;mecha ni cal characteristics; andothers, such as sterile vs. non- sterile, radioactivity etc.State the inten ded applicati on of the device,si ngle use/reusable; in vasive/nonin vasive; impla ntable; durati on of use or con tact with the body; orga ns, t

6、issues or body fluids con tacted by the device.Describe how the device achieves its inten ded purpose.對該器械進(jìn)行簡明的物理描述，適當(dāng)參照生產(chǎn)商技術(shù)信息的相關(guān)章節(jié)。此描述應(yīng)包含的信息，如：材料，包括是否含藥(已經(jīng)上市的或全新的)、組織或血液產(chǎn)品；器械組成，包括軟件和附件；機(jī)械特征；和其他，如滅菌，非滅菌，放射能等等。描述器械的預(yù)期用途，一次性使用/多次使用；侵入/非侵入；可植入；使用持續(xù)時(shí)間或與人體 接觸；器械接觸的器官，組織或體液。描述器械如何達(dá)到它的預(yù)期用途。3. Inten ded th

7、erapeutic an d/or diag no stic in dicati ons and claims預(yù)期治療和/或診斷說明和要求State the medical con diti ons to be treated, in clud ing target treatme nt group and diseases.Outli ne any specific safety or performa nee claims made for the device描述使用時(shí)的醫(yī)學(xué)條件，包括目標(biāo)治療群體和疾病。概述器械的任何特殊安全或性能要求。4. Con text of the evalua

8、tio n and choice of cli nical data types評(píng)估背景和臨床數(shù)據(jù)類型的選擇Outli ne the developme ntal con text for the device. The in formatio n should in clude whether the device is based on a new tech no logy, a new cli ni cal applicati on of an existi ng tech no logy, or the result of in creme ntal cha nge of an exi

9、sti ng tech no logy.The amount of i nformatio n will differ accord ing to the history of the tech no logy.Where a completely new tech no logy has bee n developed, this secti on would n eedto give an overview of the developme ntal process and the points in thedevelopme nt cycle at which cli ni cal da

10、ta have bee n gen erated. For long sta ndingtech no logy, a shorter descripti on of the history of the tech no logy (withappropriate refere nces) could be used.Clearly state if the clinical data used in theevaluati on are for an equivale nt device.Ide ntify the equivale nt device(s) andprovide a jus

11、tificati on of the equivale ncy, cross-refere need to the releva ntnon-clinical documentation that supports the claim.概述器械的發(fā)展歷史。內(nèi)容應(yīng)包括器械是否基于新技術(shù)，是否基于現(xiàn)有技術(shù)的新臨床應(yīng)用，或 者是現(xiàn)有技術(shù)增量變化的結(jié)果。根據(jù)該技術(shù)的歷史，信息量將有所不同。如果是一項(xiàng)全新技術(shù) 發(fā)展起來，本章須概述發(fā)展過程和發(fā)展周期中產(chǎn)生臨床數(shù)據(jù)的節(jié)點(diǎn)。如果是常規(guī)技術(shù)，須簡短 描述該技術(shù)的歷史(須適當(dāng)引用)。明確指出，評(píng)估中使用的臨床數(shù)據(jù)是否來自等同器械。識(shí) 別等同器械，并給出等同的理由

12、，參照相關(guān)非臨床文獻(xiàn)，以支撐觀點(diǎn)。State the Esse ntial Requireme nts releva nt to the device in questi on, in particular,any special desig n features that pose special performa nee or safety concerns (e.g.prese nee of medici nal, huma n or ani mal comp onen ts) that were ide ntified in thedevice risk man ageme nt do

13、cume ntati on and that required assessme nt from acli ni cal perspective.陳述有關(guān)討論的器械的基本要求，特別是，任何導(dǎo)致特殊性能或安全特性(如藥，人體或動(dòng)物 組織的使用)的特殊設(shè)計(jì)已經(jīng)在器械風(fēng)險(xiǎn)管理文件中被識(shí)別過，并從臨床的角度進(jìn)行了必要的 評(píng)估。Outline how these considerations were used to choose the types of clinical dataused for the evaluation. Where published scientific literatur

14、e has been used, provide a brief outl ine of the search in g/retrieval process, cross-refere need to the literature search protocol and reports.概述這些需要考慮的因素如何用來選擇評(píng)估中用到的臨床數(shù)據(jù)的類型。如果引用已出版的科學(xué) 文獻(xiàn)，請簡要描述檢索/回溯過程，參照文獻(xiàn)檢索草案和報(bào)告。5. Summary of the cli nical data and appraisal總結(jié)臨床數(shù)據(jù)和評(píng)價(jià)Provide a tabulation of the cli

15、nical data used in the evaluation, categorised accord ing to whether the data address the performa nee or the safety of the device in questi on. (Note: many in dividual data sets will address both safety and performa nee.) With in each category, order the data accord ing to the importa nee of their

16、contribution to establishing the safety and performance of the device and in relati on to any specific claims about performa nce or safety. Additi on ally, provide a brief outline of the data appraisal methods used in the evaluation, including any weighting criteria, and a summary of the key results

17、.提供一張?jiān)u估中用到的臨床數(shù)據(jù)的表格，按照數(shù)據(jù)是否關(guān)系到討論的器械的性能或安全來分類。(注：許多單獨(dú)的數(shù)據(jù)與安全、性能都相關(guān)。)每個(gè)類別中，數(shù)據(jù)的排列依據(jù)它們對于該器械 安全和性能的重要性，以及與性能和安全有關(guān)的任何特別要求的相關(guān)方面。此外，簡要描述評(píng) 估中使用的數(shù)據(jù)評(píng)價(jià)方法，包括任何權(quán)重標(biāo)準(zhǔn)，和重要結(jié)論的總結(jié)。Include full citations for literature-based data and the titles and investigationcodes (if releva nt) of any cli ni cal in vestigati on reports

18、.包括任何臨床研究報(bào)告的基于文獻(xiàn)的數(shù)據(jù)，題目和研究編碼（如果相關(guān)）的完整引用信息。Cross-refere nee the entry for each piece of data to its locati on in themanu facturer' tech ni cal docume ntati on.每條數(shù)據(jù)的記錄與其在生產(chǎn)商技術(shù)文檔中的位置應(yīng)相互對應(yīng)。6. Data an alysis數(shù)據(jù)分析6.1. Performanee性能Provide a description of the analysis used to assess performanee.描述用于性能評(píng)估

19、的分析方法。Identify the datasets that are considered to be the most important in contributing to the dem on strati on of the overall performa nce of the device and, where useful, particular performa nce characteristics. Outli ne why they are con sidered to be pivotal and how they dem on strate the perfor

20、ma nce of the device collectively （e.g. consistency of results, statistical significance, clinically significance of effects）.識(shí)別那些被認(rèn)為是論證了器械總體性能和特殊性能特點(diǎn)的最重要的數(shù)據(jù)。概述這些數(shù)據(jù)為何被 認(rèn)為是關(guān)鍵數(shù)據(jù)，它們?nèi)绾喂餐撟C了器械的性能（比如結(jié)論的連貫性，統(tǒng)計(jì)的顯著性，療效 的臨床重要性）。6.2. Safety 安全Describe the total experience with the device, including numbers and

21、 characteristics of patients exposed to the device; and duration of follow-up of device recipie nts. 描述器械的全部使用經(jīng)驗(yàn)，包括使用此器械的患者的數(shù)量和特點(diǎn)；以及跟蹤器械使用情況的持 續(xù)時(shí)間。Provide a summary of device-related adverse eve nts, pay ing particular atte nti onto serious adverse eve nts.總結(jié)與器械有關(guān)的不良事件，特別注意嚴(yán)重不良事件。Provide specific co

22、mme nt on whether the safety characteristics and inten dedpurpose of the device requires training of the en d-user.要特別討論，是否會(huì)因?yàn)槠餍档陌踩匦院皖A(yù)期用途，須對最終用戶進(jìn)行培訓(xùn)。6.3. Product Literature and Instructions for Use產(chǎn)品文獻(xiàn)和使用說明State whether the manu facturer' proposed product literature and In structi ons forUse are con siste nt with the cli ni cal data and cover all the hazards and othercli ni cally releva nt in formati on that may impact on the use of the device.聲明生產(chǎn)商提到的產(chǎn)品文獻(xiàn)和使用說明書是否與臨床數(shù)據(jù)一致，并包含所有風(fēng)險(xiǎn)和其他可能影 響到器械使用的相關(guān)的臨床信息。7. Con clusi ons結(jié)論Outl ine clearly the