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

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.