3 General requirements for the performance evaluation
3.1 Responsibilities and resources
The 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 personnel who manage
and conduct the performance evaluation of IVD MDs, particularly for personnel who need the
organisational freedom and authority to
a) assess the validity of test results and data already available;
b) specify performance claims which shall be further examined or confirmed;
c) specify and document 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 evaluation
study. The co-ordinator shall himself assure that adequate resources are available. The investigator
shall ensure that the evaluation plan is followed at his location and that the study is appropriately
reviewed from an ethical point of view.
3.2 Documentation
The documentation of the performance evaluation study shall contain the files relating to clauses 3 to
7 of this standard and shall be part of the technical documentation of the IVD MD.
3.3 Final assessment and review
The co-ordinator shall assess and document which performance claims are met, state whether claims
are not met and give recommendations for corrective actions, where necessary.
The responsible management of the manufacturer shall make sure that the results of the performance
evaluation study and the recommendations for corrective actions are carefully considered and properly
documented before issuing a declaration of conformity.
4 Organisation of a performance evaluation study
4.1 Preconditions
Before starting a performance evaluation study it shall be ensured by the co-ordinator that
a) 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) a sufficient number of samples of the IVD MD can be provided during the entire period of the
performance 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 necessary
resources are available.
4.2 Evaluation plan
The evaluation plan shall state the purpose on scientific, technical or medical grounds, the scope of
the 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 assessed which performance claims
are already verified by data or scientific literature.
The evaluation plan shall be designed to minimise the requirements for invasive sampling. In the case
of IVD MDs for self-testing it shall be ensured that the evaluation plan is appropriate and acceptable to
users and the information provided shall be clear and easily understood.
The evaluation plan shall specify
a) 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 location and number of lay persons involved;
c) the time-table;
d) the necessary minimum number of probands from whom specimens are collected by invasive
procedures in order to adequately assess the performance of the IVD MD;
e) instructions for use including a description of the conditions of use;
f) the 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 resources
In general, the performance study procedure(s) shall be carried out under conditions reflecting the
relevant intended conditions of use.
The co-ordinator shall take the responsibility for the proper conduct of the performance evaluation
study at all sites. All investigators shall be named.
The co-ordinator shall ensure adequate competence and skill at all sites involved and that the
necessary resources are available.
Where lay persons are involved in a performance evaluation study of an IVD MD for self-testing, the
location of the study and the number of persons shall be given. The co-ordinator shall specify the
criteria for the selection of a representative panel.
Especially for studies involving lay persons it shall be ensured that these persons do not receive
additional information on the use of the IVD MD apart from that which is provided with the IVD MD
when it is placed on the market because the comprehension of the manufacturer's instructions for use
is one of the important aspects of the study. lt shall also be ensured that the untrained person(s) do
not receive any additional information or help, e. g. from a tutor, other than the training specified and
provided by the manufacturer in the instructions for use.
4.4 Basic design information
The co-ordinator shall provide the investigator(s) with sufficient information in order to understand the
function and application of the IVD MD and, where necessary, the investigator shall make himself
familiar with the IVD MD and its application. The information provided shall include a statement that
the device in question conforms with the requirements of the Directive 98/79/EC apart from those to be
evaluated.
4.5 Experimental design
The experimental procedures to validate each performance claim subject to the performance
evaluation study shall be documented in the evaluation plan.
Special consideration in performance evaluation studies of reagents/kits shall be given, where
applicable, to the following:
– specification of type (e.g. serum, plasma, urine) and properties (e.g. concentration range, age
and sex of the proband population) of specimens appropriate to the intended use;
– probands to be enrolled;
– 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 the
pathological/physiological status of the specimen donor or treatment;
– conditions for use which can be reasonably anticipated; special attention shall be paid to the
conditions of use by lay persons;
– selection of an appropriate reference measurement procedure and reference material of
higher order, where available;
– determination of the status of specimens (for qualitative tests with 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 of
unexpected results 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 consideration
shall be given additionally to the following:
– maintenance and cleaning;
– carry-over effects;
– software validation.
NOTE For the investigation of the technical aspects of instruments, other standards can be relevant.
4.6 Performance study records
The performance study records shall
– refer to the experimental procedures in the evaluation plan;
– be unequivocally identifiable;
– contain or refer to all results and related relevant 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 outcomes
Special attention shall be paid to observations and unexpected outcomes, e. g. drop outs, outliers,
instability of sample or reagent signal etc., non-reproducibility, non-correlation of results to the
reference 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 any difficulty or question a user may have and any deviation
from 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 recorded and shall be part of the evaluation
report.
Where the validity of the examinations already performed may be questionable because of an
identified 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 cause and where an
unexpected risk inherent to the product design or the mode of application has been identified this shall
be clearly stated.
The proposals of the investigator(s) and the co-ordinator for any improvement of the IVD MD and/or its
application shall be recorded.
4.8 Evaluation report
The co-ordinator shall establish an evaluation report. It shall contain a description of the study, an
analysis 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 the
cause whenever possible and give recommendations for corrective actions to be taken, where
necessary.
If several studies have been conducted for one IVD MD, a single summarizing report may be
established.
5 Modifications during the performance evaluation study
Where the manufacturing process has been changed it shall be checked whether the performance
claims of the IVD MD still conform to those which had been set initially. Otherwise the validity of the
examinations already performed shall be questioned and the evaluation plan shall be revised
accordingly.
Where design changes are introduced, the evaluation plan shall be revised.
6 Re-evaluation
In case of changes to the design or manufacturing process of the IVD MD, the performance evaluation
study shall be repeated as far as necessary, to ensure that the intended use and the performance
claims of the IVD MD placed on the market are adequately evaluated.
This re-evaluation may refer to documented results of a preceding evaluation insofar as these are considered valid and transferable after critical review.
7 Protection and safety of probands
The removal, collection and use of tissues, cells and substances of human origin is governed, in
relation to ethics, by the principles laid down in the Convention of the Council of Europe for the
protection of human rights and dignity of the human being with regard to the application of biology and
medicine and by any national regulations on this matter.
In any case, the results obtained from a specimen by means of the IVD MD under evaluation shall not
be used for other purposes than for performance evaluation, unless ethical reasons, fully supported by
a responsible medical professional, suggest the contrary. In such a case the medical professional
assumes complete responsibility.
3 性能評估的一般要求
3.1 責任和謀略
生產(chǎn)商負責性能評估研究的開始和/或引導。他應規(guī)范明確所有管理和引導IVD-MD性能評估的人員的責任和相互關系，尤其對那些需要組織的自由和授權進行
1， 評估已有的測試結果和數(shù)據(jù)的有效性。
2， 詳述/指定需要進一步檢查或確認的性能聲明。
3， 詳述/指定并記錄評估計劃及測試過程。
4， 準備評估報告。
生產(chǎn)商應指定一個協(xié)調(diào)者總體負責性能評估研究。協(xié)調(diào)者應確保具有所需的才智能力。審查者應確保在他手上評估計劃正確軌道進行，并且在倫理學上合適。
3.2 記錄
性能研究的記錄應包括相關于本標準的條款3到7要求的文件。并應成為IVD MD技術文檔的一部分。
3.3 最終評估和回顧
協(xié)調(diào)者應評估并記錄那些性能聲明是符合的，表明是否有不符合的聲明并需要的話，給出改進建議。
生產(chǎn)商的負責任的管理應確保性能評估研究的結果和改進建議受到仔細考慮并適當記錄，然后才能發(fā)布（評估結果的）一致性聲明。
4. 組織一個性能評估研究
4.1 先決條件
在開始實驗前，協(xié)調(diào)者需要確保
1. IVD MD的性能聲明，也就是研究的主題是指定的。
2. IVD MD 在受約束的生產(chǎn)過程和條件下生產(chǎn)出來了。
3. 要評估的IVD MD 符合質量控制標準。
4. 在全部研究過程中有充足數(shù)目的IVD MD樣品提供。
5. 符合所有的法律法規(guī)對性能評估研究的要求。
6. 研究者具有足夠的技能并被培訓過，進行試驗，同時，足夠的資料可以得到。
4.2 評估計劃
評估計劃需講述從科學，技術或醫(yī)學的背景上的目標，評估的范圍，所進行的研究的組織結構以及有關的（醫(yī)療）設備（此處應指實驗對象，也就是試劑）的數(shù)目。
在明確實驗目標時，協(xié)調(diào)者應核定哪些性能聲明已經(jīng)被數(shù)據(jù)或科學文獻所核實。
設計評估計劃時，應最小化有擴散危害的樣品的需求。在IVD MD用來自我測試的情況下，應確保評估計劃是適當?shù)?，并讓使用者可（理解）接受，同時所提供的信息應清晰并易理解。
評估計劃應詳述并指定：
1. 研究者具有足夠的使用IVD MD的技能和培訓。
2. 列出參與性能評估實驗的實驗室或機構；對自我測試的情況，需要包括參與實驗人員（普通人，無醫(yī)學背景的人）的定位和數(shù)目。
3. 時間表
4. 所必需的最小數(shù)目的人群，他們的樣本通過侵入性過程所采集，用來確切評估IVD MD性能。
5. 操作指南包括使用條件的描述。
6. 所認證的性能聲明（例如，分析敏感度，診斷敏感度，分析特異性，診斷特異性，精度，可重復性，重復能力）
7. 性能研究記錄的格式。
4.3 位置和資料
總體上，性能研究過程應在反應出實際使用條件相關的情況下進行。
協(xié)調(diào)者應負責性能評估過程各步驟的適當?shù)闹笇?。所有的研究者應留下姓名?/p>
協(xié)調(diào)者應確保在各步驟都具有足夠的技能并有必須的謀略。
當普通人卷入自我測試的研究時候，需要給出進行研究的地址和人員數(shù)目。協(xié)調(diào)者應詳述代表性的小組的選擇的標準。
尤其當研究包括普通人時候，應確保這些人員不會得到額外的使用IVD MD的信息，除了在投放市場時候所提供的和IVD MD一起的信息，因為對生產(chǎn)商的使用指南的理解是研究所包括的一個重要方面。也需要確保未受訓人員（普通人）不會得到額外的信息與幫助，比如從一個導師那里，除了那些廠商的使用指南中的那些訓練。
4.4 基本設計信息
協(xié)調(diào)者需提供給研究者足夠的信息，以理解IVD MD 的功能和應用，并且，當需要時，研究者自己應熟悉IVD MD及應用。所提供的信息應包括一個陳述，所研究的設備（實驗對象）符合98/79/EC標準要求，不僅僅是評估的那些。
4.5 實驗設計
實驗過程的每一步都需要記錄在評估計劃中。
試劑/裝備的性能評估研究所需要的特別考慮，當需要時，需要給定，例如：
-所適用的標本的種類（如：血清，血漿，尿液）和屬性（如：濃度范圍，實驗的人口的年齡和性別）
-實驗人群
-標本的合適性，穩(wěn)定性與數(shù)量及排除標準。
-雙盲過程，如果需要的話。
-試劑穩(wěn)定性
-由標本條件或標本捐獻者的病理/生理狀態(tài)引起的常見干擾因子。
-可以合理預測到的使用條件；尤其是普通人使用所需的條件。
-選擇合適的更高層次的參考測量過程和材料，需要的話。
-決定標本的狀態(tài)（用來定性測試的少量的或序數(shù)的等級）
-校準過程，包括需要時的可追溯性
-合適的對照方法
-實驗的弱點，限制。
-重新檢測及數(shù)據(jù)剔除的規(guī)范。
-可用的額外的關于樣本或捐者的信息，若需要對不符合期望的結果進行追訪。
-適當?shù)氖侄蝸頊p少使用者感染的危險。
當研究試圖驗證一個儀器的性能聲明時，下面的特別考慮也需要給定：
-維護和清潔
-延期的影響
-軟件確認。
注意：對于儀器的技術方面的研究者，還有其他的可能相關的標準。
4.6 性能研究記錄
記錄應：
-參照評估計劃中的實驗過程
-毫不含糊地確認
-包括或參照所有結果及相關數(shù)據(jù)。
-成為IVD MD的技術文檔的一部分。
機密數(shù)據(jù)的保護需要確保。
4.7 觀測和非期待的結果
需要特別的注意觀測與不符的結果，例如，丟棄的結果，外層的結果，樣品或試劑的不穩(wěn)定性信號等等，不可重復性，結果對參考值或對診斷模式的不相關性，缺陷或故障，軟件錯誤，或誤差信號。
任何對確切的（實驗）過程的偏離都應被記錄。在自測IVD MD的案例中，研究者或導師應準確標注使用者可能遇到的問題及困難，以及對IVD MD生產(chǎn)商的使用指南所描述的使用方式的偏差。
所有的這些觀測應被正確記錄?？赡艿脑?，協(xié)調(diào)者應與研究者一道，探求原因。結果應被記錄并成為評估報告的部分。
當已經(jīng)完成的檢測的有效性被質疑，因為識別了錯誤的根源，那么這個測試應該被重復，在排除了該錯誤原因后。
當一個對用戶指南的錯誤解讀或錯誤使用成為原因，以及那些起源于產(chǎn)品設計或應用方式的非預期的風險被識別，需要被清晰稱述。
研究者及協(xié)調(diào)者對IVD MD 的改進和/或使用的提議應被記錄。
4.8 測評報告
協(xié)調(diào)者應建立評估報告。應包括對研究的描述，結果的分析和對所研究的性能聲明的結論。
報告也應該討論所發(fā)生的任何非期望的結果。應辨別可能的原因并給予糾正的推薦行為，當需要的時候。
當對同一個IVD MD的幾個研究都進行，應該建立一個獨立的總結報告。
5 性能評估研究的修改
當生產(chǎn)過程改變時候，應當檢查IVD MD的性能聲明是否仍然符合那些最初設置的。否則，那些已經(jīng)進行了的檢測應被質疑，同時，評估計劃該做相應修改。
6 重新分析
當IVD MD設計或生產(chǎn)過程有所改變，性能測試研究，只要需要，應被重復，以保證投放市場的IVD MD的使用目的和性能聲明被恰當評估。這重評估可以參照以前的記錄了的評估結果，只要它們在關鍵回顧后被認可有效和可轉換。
7 參加實驗人員的安全與保護
對源自人身的組織，細胞和物質的移除，收集和使用，應根據(jù)倫理學來監(jiān)控，由
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