体外诊断试剂IVD欧盟EN13612性能评估部分中英文.docx

1、体外诊断试剂IVD欧盟EN13612性能评估部分中英文3 General requirements for the performance evaluation3.1 Responsibilities and resourcesThe manufacturer takes the responsibility for the initiation and/or the conduct of a performance evaluation study. He shall define the responsibility and the interrelation of all personn

2、el who manageand conduct the performance evaluation of IVD MDs, particularly for personnel who need theorganisational freedom and authority toa) assess the validity of test results and data already available;b) specify performance claims which shall be further examined or confirmed;c) specify and do

3、cument the evaluation plan and the test procedures;d) prepare the evaluation report.The manufacturer shall appoint a co-ordinator with overall responsibility of the performance evaluationstudy. The co-ordinator shall himself assure that adequate resources are available. The investigatorshall ensure

4、that the evaluation plan is followed at his location and that the study is appropriatelyreviewed from an ethical point of view.3.2 DocumentationThe documentation of the performance evaluation study shall contain the files relating to clauses 3 to7 of this standard and shall be part of the technical

5、documentation of the IVD MD.3.3 Final assessment and reviewThe co-ordinator shall assess and document which performance claims are met, state whether claimsare not met and give recommendations for corrective actions, where necessary.The responsible management of the manufacturer shall make sure that

6、 the results of the performanceevaluation study and the recommendations for corrective actions are carefully considered and properlydocumented before issuing a declaration of conformity.4 Organisation of a performance evaluation study4.1 PreconditionsBefore starting a performance evaluation study it

7、 shall be ensured by the co-ordinator thata) the performance claims of the IVD MD which are the subject of the study are specified;b) the IVD MD has been manufactured under controlled production processes and conditions;c) the IVD MD to be evaluated meets the quality control release specifications;d

8、) a sufficient number of samples of the IVD MD can be provided during the entire period of theperformance evaluation study;e) all legal requirements for performance evaluation studies are met;f) the investigator(s) is (are) adequately skilled and trained to conduct the study and the necessaryresourc

9、es are available.4.2 Evaluation planThe evaluation plan shall state the purpose on scientific, technical or medical grounds, the scope ofthe evaluation, the structure and organization of the study and the number of devices concerned.Defining the objective of the study, the co-ordinator shall have as

10、sessed which performance claimsare already verified by data or scientific literature.The evaluation plan shall be designed to minimise the requirements for invasive sampling. In the caseof IVD MDs for self-testing it shall be ensured that the evaluation plan is appropriate and acceptable tousers and

11、 the information provided shall be clear and easily understood.The evaluation plan shall specifya) that the investigator(s) is (are) adequately skilled and trained to use the IVD MD;b) the list of laboratories or other institutions taking part in the performance evaluation study; for selftesting,the

12、 location and number of lay persons involved;c) the time-table;d) the necessary minimum number of probands from whom specimens are collected by invasiveprocedures in order to adequately assess the performance of the IVD MD;e) instructions for use including a description of the conditions of use;f) t

13、he performance claims (e.g. analytical sensitivity, diagnostic sensitivity, analytical specificity,diagnostic specificity, accuracy, repeatability, reproducibility) to be validated;g) the format of performance study records.4.3 Sites and resourcesIn general, the performance study procedure(s) shall

14、be carried out under conditions reflecting therelevant intended conditions of use.The co-ordinator shall take the responsibility for the proper conduct of the performance evaluationstudy at all sites. All investigators shall be named.The co-ordinator shall ensure adequate competence and skill at all

15、 sites involved and that thenecessary resources are available.Where lay persons are involved in a performance evaluation study of an IVD MD for self-testing, thelocation of the study and the number of persons shall be given. The co-ordinator shall specify thecriteria for the selection of a represent

16、ative panel.Especially for studies involving lay persons it shall be ensured that these persons do not receiveadditional information on the use of the IVD MD apart from that which is provided with the IVD MDwhen it is placed on the market because the comprehension of the manufacturers instructions f

17、or useis one of the important aspects of the study. lt shall also be ensured that the untrained person(s) donot receive any additional information or help, e. g. from a tutor, other than the training specified andprovided by the manufacturer in the instructions for use.4.4 Basic design informationTh

18、e co-ordinator shall provide the investigator(s) with sufficient information in order to understand thefunction and application of the IVD MD and, where necessary, the investigator shall make himselffamiliar with the IVD MD and its application. The information provided shall include a statement that

19、the device in question conforms with the requirements of the Directive 98/79/EC apart from those to beevaluated.4.5 Experimental designThe experimental procedures to validate each performance claim subject to the performanceevaluation study shall be documented in the evaluation plan.Special consider

20、ation in performance evaluation studies of reagents/kits shall be given, whereapplicable, to the following: specification of type (e.g. serum, plasma, urine) and properties (e.g. concentration range, ageand sex of the proband population) of specimens appropriate to the intended use; probands to be e

21、nrolled; suitability, stability and volume of specimens and specimen exclusion criteria; blind procedures, where necessary; reagent stability; inclusion of common interfering factors, caused by specimen condition or thepathological/physiological status of the specimen donor or treatment; conditions

22、for use which can be reasonably anticipated; special attention shall be paid to theconditions of use by lay persons; selection of an appropriate reference measurement procedure and reference material ofhigher order, where available; determination of the status of specimens (for qualitative tests wit

23、h a nominal or ordinal scale); calibration procedures, including traceability, where appropriate; appropriate means of control; limitations of the test; criteria for re-examination and data exclusion; availability of additional information concerning the specimen or donor if follow-up ofunexpected r

24、esults is required; appropriate measures to reduce risk of infection to the user.Where the study is intended to validate the performance claims of an instrument special considerationshall be given additionally to the following: maintenance and cleaning; carry-over effects; software validation.NOTE F

25、or the investigation of the technical aspects of instruments, other standards can be relevant.4.6 Performance study recordsThe performance study records shall refer to the experimental procedures in the evaluation plan; be unequivocally identifiable; contain or refer to all results and related relev

26、ant data; be part of the technical documentation of the IVD MD.The protection of all confidential data shall be ensured.4.7 Observations and unexpected outcomesSpecial attention shall be paid to observations and unexpected outcomes, e. g. drop outs, outliers,instability of sample or reagent signal e

27、tc., non-reproducibility, non-correlation of results to thereference or to the diagnostic pattern, defects or breakdowns, software errors, or error signals.Any deviation from the defined procedures shall be recorded. In the case of IVD MDs for self-testing,the investigator or tutor shall duly note a

28、ny difficulty or question a user may have and any deviationfrom the mode of application of the IVD MD as described by the manufacturer.Any such observation shall be properly recorded. The co-ordinator shall, together with the investigator,trace the cause whenever possible. The result shall be record

29、ed and shall be part of the evaluationreport.Where the validity of the examinations already performed may be questionable because of anidentified source of error the tests shall be repeated after exclusion of that cause.Where a misuse or misinterpretation of the instructions for use has been the cau

30、se and where anunexpected risk inherent to the product design or the mode of application has been identified this shallbe clearly stated.The proposals of the investigator(s) and the co-ordinator for any improvement of the IVD MD and/or itsapplication shall be recorded.4.8 Evaluation reportThe co-ord

31、inator shall establish an evaluation report. It shall contain a description of the study, ananalysis of the results together with a conclusion on the performance claims investigated.The report shall also discuss any unexpected outcomes which have occurred. It shall identify thecause whenever possibl

32、e and give recommendations for corrective actions to be taken, wherenecessary.If several studies have been conducted for one IVD MD, a single summarizing report may beestablished.5 Modifications during the performance evaluation studyWhere the manufacturing process has been changed it shall be checked whether the performanceclaims of the IVD MD still conform to those which had been set initiall