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(xing)能評估的(de)一般要求
3.1 責(ze)任(ren)和謀略
生產商負責性能評估研究的開始和/或(huo)引導。他應(ying)規范明(ming)確(que)所有管理和(he)引導IVD-MD性(xing)能評估的(de)人(ren)員的(de)責任和相(xiang)互關系，尤其對(dui)那些(xie)需要組織(zhi)的(de)自由(you)和授權(quan)進行
1， 評估(gu)已有的測試(shi)結(jie)果和數據的有效性。
2， 詳述/指定需要(yao)進一步檢查或確認(ren)的(de)性能聲明。
3， 詳述/指定并記錄評估(gu)計劃及測試過程。
4， 準備評估報(bao)告(gao)。
生產商應(ying)(ying)(ying)指定一個協調(diao)(diao)者總體負責性能評估(gu)研究。協調(diao)(diao)者應(ying)(ying)(ying)確保(bao)(bao)具有所(suo)需(xu)的才智能力。審(shen)查者應(ying)(ying)(ying)確保(bao)(bao)在他手上評估(gu)計劃(hua)正確軌道(dao)進行，并且在倫理學上合適(shi)。
3.2 記(ji)錄(lu)
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(bing)應成為IVD MD技術文(wen)檔的(de)一部分。
3.3 最終評估和回顧(gu)
協調(diao)者應評估并記錄那些(xie)性能(neng)聲(sheng)(sheng)明(ming)是符(fu)合(he)的，表明(ming)是否有不符(fu)合(he)的聲(sheng)(sheng)明(ming)并需要的話，給(gei)出(chu)改進建(jian)議。
生產商的負責任(ren)的管理應確保性(xing)能(neng)評估研(yan)究的結(jie)果和改進建議受到仔細考慮并(bing)適當記(ji)錄，然(ran)后才能(neng)發布（評估結(jie)果的）一致性(xing)聲(sheng)明。
4. 組織一個性(xing)能(neng)評估研究
4.1 先決條件
在開始實驗前，協調者需要(yao)確保
1. IVD MD的(de)性(xing)能聲明，也(ye)就是(shi)研究的(de)主題是(shi)指(zhi)定的(de)。
2. IVD MD 在受約(yue)束的生(sheng)(sheng)產(chan)過程和條件下生(sheng)(sheng)產(chan)出來了。
3. 要評估的IVD MD 符合質(zhi)量控制標準。
4. 在全部研究過程中有充足數目的IVD MD樣品提供。
5. 符合所(suo)有的法律法規對性能評估(gu)研究的要(yao)求(qiu)。
6. 研究者具有足夠(gou)的(de)技能并被培(pei)訓(xun)過，進行試驗，同時，足夠(gou)的(de)資(zi)料可以(yi)得到。
4.2 評估計劃
評估(gu)計劃需講述從科學(xue)(xue)，技術或(huo)醫學(xue)(xue)的(de)背(bei)景上的(de)目(mu)標，評估(gu)的(de)范圍，所進行(xing)的(de)研究的(de)組織結構以及有關的(de)（醫療）設備（此處應指實驗對象，也就是試劑）的(de)數(shu)目(mu)。
在明確實驗目標時，協調者(zhe)應核定哪些(xie)性能聲明已經(jing)被(bei)數據(ju)或科(ke)學文(wen)獻所(suo)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(de)情況下，應確(que)保(bao)評估計劃是適當的(de)，并(bing)讓使用者(zhe)可（理解）接受(shou)，同(tong)時所提(ti)供的(de)信息應清晰(xi)并(bing)易(yi)理解。
評(ping)估計劃應詳述并指(zhi)定：
1. 研究者具有足夠的使用IVD MD的技能(neng)和培訓。
2. 列出參與(yu)性能(neng)評(ping)估實(shi)(shi)驗的實(shi)(shi)驗室或機構；對自我測(ce)試的情況，需要包括參與(yu)實(shi)(shi)驗人(ren)員（普(pu)通(tong)人(ren)，無(wu)醫學背景的人(ren)）的定位和(he)數目。
3. 時間表(biao)
4. 所必需的最小數目的人群，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(kuo)使用條件的描(miao)述(shu)。
6. 所(suo)認證的性(xing)(xing)能(neng)(neng)聲明（例如，分(fen)析敏(min)感度(du)，診(zhen)斷(duan)敏(min)感度(du)，分(fen)析特(te)異性(xing)(xing)，診(zhen)斷(duan)特(te)異性(xing)(xing)，精度(du)，可重(zhong)復性(xing)(xing)，重(zhong)復能(neng)(neng)力(li)）
7. 性(xing)能研究記錄的格(ge)式。
4.3 位(wei)置和資(zi)料
總(zong)體上，性能(neng)研究過(guo)程應在反應出實際使用條(tiao)件相關的情(qing)況(kuang)下進行(xing)。
協調者(zhe)(zhe)應負責性能評估過(guo)程各步驟的適當(dang)的指導(dao)。所(suo)有(you)的研究者(zhe)(zhe)應留(liu)下姓名。
協調者(zhe)應(ying)確保在(zai)各步驟都具有足夠的技(ji)能并(bing)有必須(xu)的謀略。
當普通人卷入自我測試的(de)研究(jiu)時(shi)候(hou)，需要(yao)給出進行(xing)研究(jiu)的(de)地址和人員數(shu)目。協調者應詳述代表性(xing)的(de)小(xiao)組的(de)選擇(ze)的(de)標準(zhun)。
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(yi)起的(de)(de)信息(xi)，因為對生產商的(de)(de)使(shi)用(yong)指南(nan)(nan)的(de)(de)理解是研(yan)究(jiu)所包括的(de)(de)一(yi)個(ge)重(zhong)要(yao)方面。也需要(yao)確(que)保未受(shou)訓人員(yuan)（普通人）不會(hui)得到額(e)外的(de)(de)信息(xi)與幫助，比(bi)如從一(yi)個(ge)導師那(nei)(nei)里，除了那(nei)(nei)些廠商的(de)(de)使(shi)用(yong)指南(nan)(nan)中的(de)(de)那(nei)(nei)些訓練。
4.4 基本(ben)設計信息(xi)
協調者需提供給研究者足夠的信息，以理解IVD MD 的功能和應(ying)用，并(bing)且，當需要時，研究者自己應(ying)熟悉IVD MD及(ji)應(ying)用(yong)。所(suo)提供的(de)信息應(ying)包括一個陳述(shu)，所(suo)研究的(de)設備（實驗對象）符(fu)合98/79/EC標準要求，不(bu)僅(jin)僅(jin)是評估的那些。
4.5 實驗(yan)設計
實驗過程的每一步都需要記錄在評估(gu)計劃中。
試劑/裝備的(de)性能評估研(yan)究所需(xu)要的(de)特別考慮，當需(xu)要時，需(xu)要給定，例如(ru)：
-所(suo)適用的標(biao)本的種類（如(ru)：血清，血漿，尿液(ye)）和屬性(xing)(xing)（如(ru)：濃度范(fan)圍，實驗(yan)的人口的年齡和性(xing)(xing)別）
-實驗人群
-標(biao)(biao)本的合適性(xing)，穩定性(xing)與數量及排除標(biao)(biao)準(zhun)。
-雙盲(mang)過程，如(ru)果需要的話。
-試(shi)劑穩定性(xing)
-由標本條件或標本捐獻(xian)者(zhe)的(de)病理/生理狀(zhuang)態引起的常見干(gan)擾因子。
-可以合理預(yu)測到的使用(yong)(yong)條(tiao)件(jian)；尤(you)其(qi)是(shi)普通(tong)人使用(yong)(yong)所需的條(tiao)件(jian)。
-選擇合適的更高層次的參考測(ce)量過程和材料(liao)，需(xu)要的話。
-決定(ding)(ding)標本的狀態（用(yong)來定(ding)(ding)性測試的少量的或(huo)序(xu)數的等(deng)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(dian)，限(xian)制。
-重(zhong)新檢(jian)測及數據剔(ti)除(chu)的規(gui)范。
-可(ke)用(yong)的(de)額外的(de)關于(yu)樣(yang)本或捐者的(de)信息，若需要對不符合期(qi)望的(de)結果(guo)進行追訪。
-適當的手(shou)段來減少使用者感染的危險。
當(dang)研(yan)究試圖驗證一個儀器的性能(neng)聲明時(shi)，下面的特別(bie)考慮也需要給(gei)定：
-維(wei)護和清(qing)潔
-延期的影響
-軟(ruan)件確認。
注意：對(dui)于(yu)儀器的技術方面的研究(jiu)者，還(huan)有其他(ta)的可能相關的標準。
4.6 性(xing)能研究記錄
記錄應：
-參照評估計劃(hua)中的實驗過程
-毫不含糊地確認(ren)
-包括或參(can)照(zhao)所有結果及相關數據(ju)。
-成為IVD MD的技術文檔的一(yi)部分。
機密數據的保(bao)護需要確(que)保(bao)。
4.7 觀測和非期待的結果(guo)
需(xu)要特別的(de)注意觀(guan)測(ce)與不(bu)符的(de)結果，例如，丟棄的(de)結果，外層的(de)結果，樣品或試劑的(de)不(bu)穩定性(xing)信號(hao)等等，不(bu)可重復(fu)性(xing)，結果對(dui)參考值或對(dui)診斷模式的(de)不(bu)相關性(xing)，缺陷(xian)或故(gu)障(zhang)，軟件(jian)錯誤(wu)，或誤(wu)差信號(hao)。
任何對確切的（實驗）過程的偏離都應被記錄。在自測IVD MD的(de)案(an)例(li)中(zhong)，研(yan)究者(zhe)或(huo)導師(shi)應準確(que)標注使用者(zhe)可能遇到(dao)的(de)問(wen)題及(ji)困難，以及(ji)對IVD MD生產商的(de)使(shi)用指南所描述(shu)的(de)使(shi)用方式(shi)的(de)偏差。
所有的(de)這(zhe)些觀測應(ying)被正確記(ji)錄。可能的(de)話，協調者應(ying)與(yu)研究者一道，探求(qiu)原因(yin)。結果應(ying)被記(ji)錄并成為評估報告(gao)的(de)部分(fen)。
當已經完(wan)成的檢測的有效性被質疑，因(yin)(yin)為(wei)識(shi)別了錯誤的根(gen)源，那么這個測試應該(gai)被重復，在排除了該(gai)錯誤原因(yin)(yin)后。
當一個對用(yong)戶(hu)指南的錯誤解(jie)讀或錯誤使用(yong)成(cheng)為原(yuan)因(yin)，以(yi)及那些起源于產品設計或應用(yong)方(fang)式的非(fei)預期的風險被(bei)識別，需(xu)要(yao)被(bei)清晰稱述。
研究者及協調者對IVD MD 的改進和/或使用的提(ti)議應被記錄。
4.8 測評報(bao)告
協調(diao)者應建(jian)立評估報告。應包(bao)括對(dui)研究的(de)描述，結(jie)(jie)果(guo)的(de)分(fen)析和對(dui)所研究的(de)性(xing)能聲明(ming)的(de)結(jie)(jie)論(lun)。
報(bao)告也應該討論所發生(sheng)的(de)任何(he)非(fei)期望的(de)結(jie)果(guo)。應辨別可(ke)能的(de)原因并(bing)給予(yu)糾(jiu)正(zheng)的(de)推薦行(xing)為(wei)，當需要的(de)時候(hou)。
當對同一個IVD MD的(de)幾個研究都(dou)進行，應該(gai)建(jian)立一(yi)個獨立的(de)總(zong)結報告(gao)。
5 性能評估研(yan)究的修改
當生產過程改變時候，應當檢查IVD MD的(de)性能聲明是否(fou)仍(reng)然符合那(nei)些(xie)最初設(she)置的(de)。否(fou)則，那(nei)些(xie)已經(jing)進行了的(de)檢測應被質疑，同時，評估計(ji)劃該做相應修(xiu)改。
6 重新分析
當IVD MD設計或生(sheng)產過程(cheng)有所改變，性能(neng)測試研(yan)究，只要需要，應被重復，以(yi)保證投放市(shi)場的IVD MD的使用目的和(he)(he)性能聲明(ming)被恰當評估。這重評估可(ke)(ke)以參(can)照以前的記錄了的評估結果，只(zhi)要它們在關鍵回顧后(hou)被認可(ke)(ke)有效和(he)(he)可(ke)(ke)轉換。
7 參加實驗(yan)人員的(de)安全與保(bao)護
對(dui)源自人身(shen)的組織(zhi)，細胞(bao)和物(wu)質的移除，收集和使用，應根據(ju)倫(lun)理學來(lai)監控，由
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