醫(yī)療器械臨床評估_中英文翻譯

1、CLINICAL EVALUATION REPORT臨床評估報告For Product: XXXX產品： XXXXDocument No. XXXXXXXX文件編號Version: 1.0版本 :Date: 2020-01-26日期:Author:作者 :Reviewed by:審閱：Approved by:批準：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器械描述和預期用途53. Intendedth

2、erapeutic and/ordiagnosticindications and claims預期治療和/或診斷說明和要求 64. Con textof the evaluati on and choice ofcli ni caldata types評估背景和臨床數據類型的選擇 65. Summary of the clinical data and appraisal總結臨床數據和評價 86. Data an alysis數據分析 96.1. Performa nee性能9安全9產品文獻和使用說明107. Con clusi ons結論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。識別器械的生產商。2. Descripti on of the device and its inten ded applicati on器械描述和預期用途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.對該器械進行簡明的物理描述，適當參照生產商技術信息的相關章節(jié)。此描述應包含的信息，如：材料，包括是否含藥(已經上市的或全新的)、組織或血液產品；器械組成，包括軟件和附件；機械特征；和其他，如滅菌，非滅菌，放射能等等。描述器械的預期用途，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。描述器械如何達到它的預期用途。3. Inten ded th

7、erapeutic an d/or diag no stic in dicati ons and claims預期治療和/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描述使用時的醫(yī)學條件，包括目標治療群體和疾病。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評估背景和臨床數據類型的選擇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。內容應包括器械是否基于新技術，是否基于現有技術的新臨床應用，或 者是現有技術增量變化的結果。根據該技術的歷史，信息量將有所不同。如果是一項全新技術 發(fā)展起來，本章須概述發(fā)展過程和發(fā)展周期中產生臨床數據的節(jié)點。如果是常規(guī)技術，須簡短 描述該技術的歷史(須適當引用)。明確指出，評估中使用的臨床數據是否來自等同器械。識 別等同器械，并給出等同的理由

12、，參照相關非臨床文獻，以支撐觀點。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.陳述有關討論的器械的基本要求，特別是，任何導致特殊性能或安全特性(如藥，人體或動物 組織的使用)的特殊設計已經在器械風險管理文件中被識別過，并從臨床的角度進行了必要的 評估。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估中用到的臨床數據的類型。如果引用已出版的科學 文獻，請簡要描述檢索/回溯過程，參照文獻檢索草案和報告。5. Summary of the cli nical data and appraisal總結臨床數據和評價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、.提供一張評估中用到的臨床數據的表格，按照數據是否關系到討論的器械的性能或安全來分類。(注：許多單獨的數據與安全、性能都相關。)每個類別中，數據的排列依據它們對于該器械 安全和性能的重要性，以及與性能和安全有關的任何特別要求的相關方面。此外，簡要描述評 估中使用的數據評價方法，包括任何權重標準，和重要結論的總結。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告的基于文獻的數據，題目和研究編碼（如果相關）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.每條數據的記錄與其在生產商技術文檔中的位置應相互對應。6. Data an alysis數據分析6.1. Performanee性能Provide a description of the analysis used to assess performanee.描述用于性能評估

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）.識別那些被認為是論證了器械總體性能和特殊性能特點的最重要的數據。概述這些數據為何被 認為是關鍵數據，它們如何共同論證了器械的性能（比如結論的連貫性，統(tǒng)計的顯著性，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驗，包括使用此器械的患者的數量和特點；以及跟蹤器械使用情況的持 續(xù)時間。Provide a summary of device-related adverse eve nts, pay ing particular atte nti onto serious adverse eve nts.總結與器械有關的不良事件，特別注意嚴重不良事件。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，是否會因為器械的安全特性和預期用途，須對最終用戶進行培訓。6.3. Product Literature and Instructions for Use產品文獻和使用說明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.聲明生產商提到的產品文獻和使用說明書是否與臨床數據一致，并包含所有風險和其他可能影 響到器械使用的相關的臨床信息。7. Con clusi ons結論Outl ine clearly the