2009/108/EC: Commission Decision of 3 February 2009 amending Decision 2002/364/EC on common technical specifications for in vitro -diagnostic medical devices (notified under document number C(2009) 565) (Text with EEA relevance)
Date: 2009-02-03
Institutions: European Commission
Subjects: European standard, harmonisation of standards, medical device, medical diagnosis

L 39/34

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Official Journal of the European Union

10.2.2009

(Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory)

II

DECISIONS

COMMISSION

COMMISSION DECISION

of 3 February 2009
amending Decision 2002/364/EC on common technical specifications for in vitro-diagnostic medical
devices

(notified under document number C(2009) 565)

(Text with EEA relevance)

(2009/108/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

regard to Directive 98/79/EC of

Having
Parliament and of
vitro-diagnostic medical devices (1),
second subparagraph of Article 5(3) thereof,

the European
the Council of 27 October 1998 on in
the

and in particular

Whereas:

The common technical specifications for in vitro-diag­
nostic medical devices are laid down in Commission
Decision 2002/364/EC (2).

In the interest of public health and in order to reflect
evolution in the
technical progress
including
performance and analytical sensitivity of devices,
it is
appropriate to revise the common technical specifications
laid down in Decision 2002/364/EC.

the

(1)

(2)

(3)

(4)

(5)

(6)

(7)

To bring the common technical specifications in line
it
with current
is
necessary
and
technical references.

scientific and technical practices
scientific
a number of

to update

In order

The requirements for HIV screening assays should be
clarified.
the performance
to ensure that
criteria appropriate to today’s technology is reflected in
the common technical specifications it is necessary to
add requirements for HIV antibody/antigen combined
tests and further specification of the sample requirements
for certain assays.

The Annex to Decision 2002/364/EC should therefore be
amended accordingly and, for the purpose of clarity, be
replaced.

Manufacturers whose devices are already on the market
should be given a transition period in order to adapt to
the new common technical specifications. On the other
hand, in the interest of public health, manufacturers who
so wish should be able to apply the new common
technical specifications before the expiry of the transition
period.

The definition of rapid test should be refined in order for
it to be more precise. For the sake of clarity further
definitions should be included.

(8)

The measures provided for
in this Decision are in
accordance with the opinion of the committee set up
by Article 6(2) of Council Directive 90/385/EEC (3),

(1) OJ L 331, 7.12.1998, p. 1.
(2) OJ L 131, 16.5.2002, p. 17.

(3) OJ L 189, 20.7.1990, p. 17.

10.2.2009

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HAS ADOPTED THIS DECISION:

Article 1

However, Member States shall allow manufacturers to apply the
requirements set out in the Annex before the dates set out in
the first and second paragraph.

The Annex to Decision 2002/364/EC is replaced by the text in
the Annex to this Decision.

This Decision is addressed to the Member States.

Article 3

Article 2

Done at Brussels, 3 February 2009.

This Decision shall apply from 1 December 2010 for those
devices first placed on the market prior to 1 December 2009.

It shall apply from 1 December 2009 for all other devices.

For the Commission

Günter VERHEUGEN
Vice-President

L 39/36

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10.2.2009

ANNEX

‘ANNEX

COMMON TECHNICAL SPECIFICATIONS (CTS) FOR IN VITRO-DIAGNOSTIC MEDICAL DEVICES

1.

SCOPE

The common technical specifications set out in this Annex shall apply for the purposes of Annex II List A to
Directive 98/79/EC.

2.

DEFINITIONS AND TERMS

(Diagnostic) sensitivity

The probability that the device gives a positive result in the presence of the target marker.

True positive

A specimen known to be positive for the target marker and correctly classified by the device.

False negative

A specimen known to be positive for the target marker and misclassified by the device.

(Diagnostic) specificity

The probability that the device gives a negative result in the absence of the target marker.

False positive

A specimen known to be negative for the target marker and misclassified by the device.

True negative

A specimen known to be negative for the target marker and correctly classified by the device.

Analytical sensitivity

Analytical sensitivity may be expressed as the limit of detection, i.e. the smallest amount of the target marker that
can be precisely detected.

Analytical specificity

Analytical specificity means the ability of the method to determine solely the target marker.

Nucleic acid amplification techniques (NAT)
The term “NAT” is used for tests for the detection and/or quantification of nucleic acids by either amplification of
a target sequence, by amplification of a signal or by hybridisation.

Rapid test
“Rapid test” means qualitative or semi-quantitative in vitro-diagnostic medical devices, used singly or in a small
series, which involve non-automated procedures and have been designed to give a fast result.

Robustness

The robustness of an analytical procedure means the capacity of an analytical procedure to remain unaffected by
small but deliberate variations in method parameters and provides an indication of its reliability during normal
usage.

Whole system failure rate

The whole system failure rate means the frequency of failures when the entire process is performed as prescribed
by the manufacturer.

Confirmation assay

Confirmation assay means an assay used for the confirmation of a reactive result from a screening assay.

Virus typing assay

Virus typing assay means an assay used for typing with already known positive samples, not used for primary
diagnosis of infection or for screening.

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Seroconversion HIV samples

Seroconversion HIV samples mean:

— p24 antigen and/or HIV RNA positive, and

— recognised by all of the antibody screening tests, and

— positive or indeterminate confirmatory assays,

Early seroconversion HIV samples

Early seroconversion HIV samples mean:

— p24 antigen and/or HIV RNA positive, and

— not recognised by all of the antibody screening tests, and

— indeterminate or negative confirmatory assays.

3.

3.1.

COMMON TECHNICAL SPECIFICATIONS (CTS) FOR PRODUCTS REFERRED TO IN ANNEX II, LIST A OF
DIRECTIVE 98/79/EC

CTS for performance evaluation of reagents and reagent products for the detection, confirmation and
quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTLV I and II, and
hepatitis B, C, D

General Principles

3.1.1. Devices which detect virus infections placed on the market for use as either screening or diagnostic tests, shall
meet the requirements for sensitivity and specificity set out in Table 1. See also principle 3.1.11 for screening
assays.

3.1.2. Devices intended by the manufacturer for testing body fluids other than serum or plasma, e.g. urine, saliva, etc.
shall meet the same CTS requirements for sensitivity and specificity as serum or plasma tests. The performance
evaluation shall test samples from the same individuals in both the tests to be approved and in a respective
serum or plasma assay.

3.1.3. Devices intended by the manufacturer for self-test, i.e. home use shall meet the same CTS requirements for
sensitivity and specificity as respective devices for professional use. Relevant parts of the performance evaluation
shall be carried out (or repeated) by appropriate lay users to validate the operation of the device and the
instructions for use.

3.1.4. All performance evaluations shall be carried out in direct comparison with an established state-of-the-art device.
if on the market at the time of the

The device used for comparison shall be one bearing CE marking,
performance evaluation.

3.1.5.

If discrepant test results are identified as part of an evaluation, these results shall be resolved as far as possible,
for example:

— by evaluation of the discrepant sample in further test systems,

— by use of an alternative method or marker,

— by a review of the clinical status and diagnosis of the patient, and

— by the testing of follow-up-samples.

3.1.6.

Performance evaluations shall be performed on a population equivalent to the European population.

3.1.7.

Positive specimens used in the performance evaluation shall be selected to reflect different stages of the respective
disease(s), different antibody patterns, different genotypes, different subtypes, mutants, etc.

3.1.8.

Sensitivity with true positives and seroconversion samples shall be evaluated as follows:

3.1.8.1. Diagnostic test sensitivity during seroconversion has to represent the state of the art. Whether further testing of
the same or additional seroconversion panels is conducted by the notified body or by the manufacturer the
results shall confirm the initial performance evaluation data (see Table 1). Seroconversion panels should start
with a negative bleed(s) and should have narrow bleeding intervals.

L 39/38

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3.1.8.2. For blood screening devices (with the exception of HBsAg and anti-HBc tests), all true positive samples shall be
identified as positive by the device to be CE marked (Table 1). For HBsAg and anti-HBc tests the new device shall
have an overall performance at least equivalent to that of the established device (see 3.1.4).

3.1.8.3. Regarding HIV tests:

— all seroconversion HIV samples shall be identified as positive, and

— at least 40 early seroconversion HIV samples shall be tested. Results should conform to the state of the art.

3.1.9.

Performance evaluation of screening assays shall include 25 positive (if available in the case of rare infections)
“same day” fresh serum and/or plasma samples (≤ 1 day after sampling).

3.1.10. Negative specimens used in a performance evaluation shall be defined so as to reflect the target population for

which the test is intended, for example blood donors, hospitalised patients, pregnant women, etc.

3.1.11. For performance evaluations for screening assays (Table 1) blood donor populations shall be investigated from at
least two blood donation centres and consist of consecutive blood donations, which have not been selected to
exclude first-time donors.

3.1.12. Devices shall have a specificity of at least 99,5 % on blood donations, unless otherwise indicated in the
false

accompanying tables. Specificity shall be calculated using the frequency of repeatedly reactive (i.e.
positive) results in blood donors negative for the target marker.

3.1.13. Devices shall be evaluated to establish the effect of potential interfering substances, as part of the performance
evaluation. The potential interfering substances to be evaluated will depend to some extent on the composition
of the reagent and configuration of the assay. Potential interfering substances shall be identified as part of the
risk analysis required by the essential requirements for each new device but may include, for example:

— specimens representing “related” infections,

— specimens from multipara,

positive patients,

i.e. women who have had more than one pregnancy, or rheumatoid factor

— for recombinant antigens, human antibodies to components of the expression system, for example anti-E.

coli, or anti-yeast,

3.1.14. For devices intended by the manufacturer to be used with serum and plasma the performance evaluation must
demonstrate serum to plasma equivalency. This shall be demonstrated for at least 50 donations (25 positive and
25 negative).

3.1.15. For devices intended for use with plasma the performance evaluation shall verify the performance of the device
using all anticoagulants which the manufacturer indicates for use with the device. This shall be demonstrated for
at least 50 donations (25 positive and 25 negative).

3.1.16. As part of the required risk analysis the whole system failure rate leading to false-negative results shall be

determined in repeat assays on low-positive specimens.

3.1.17.

If a new in vitro-diagnostic medical device belonging to Annex II List A is not specifically covered by the
common technical specification, the common technical specification for a related device should be taken into
account. Related devices may be identified on different grounds, e.g. by the same or similar intended use or by
similar risks.

3.2.

Additional Requirements for HIV antibody/antigen combined tests

3.2.1. HIV antibody/antigen combined tests intended for anti-HIV and p24 antigen detection which include claims for
single p24 antigen detection shall follow Table 1 and Table 5, including criteria for analytical sensitivity for p24
antigen.

3.2.2. HIV antibody/antigen combined tests intended for anti-HIV and p24 detection which do not include claims for
single p24 detection shall follow Table 1 and Table 5, excluding criteria for analytical sensitivity for p24.

3.3.

Additional Requirements for Nucleic Acid Amplification Techniques (NAT)

The performance evaluation criteria for NAT assays can be found in Table 2.

3.3.1.

For target sequence amplification assays, a functionality control for each test sample (internal control) shall reflect
the state of the art. This control shall as far as possible be used throughout the whole process, i.e. extraction,
amplification/hybridisation, detection.

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3.3.2.

The analytical sensitivity or detection limit for NAT assays shall be expressed by the 95 % positive cut-off value.
This is the analyte concentration where 95 % of test runs give positive results following serial dilutions of an
international reference material for example a WHO standard or calibrated reference material.

3.3.3. Genotype detection shall be demonstrated by appropriate primer or probe design validation and shall also be

validated by testing characterised genotyped samples.

3.3.4.

Results of quantitative NAT assays shall be traceable to international standards or calibrated reference materials, if
available, and be expressed in international units utilised in the specific field of application.

3.3.5. NAT assays may be used to detect virus in antibody negative samples, i.e. pre-seroconversion samples. Viruses
within immune-complexes may behave differently in comparison to free viruses, for example during a centri­
fugation step. It is therefore important that during robustness studies, antibody-negative (pre-seroconversion)
samples are included.

3.3.6.

3.3.7.

3.4.

For investigation of potential carry-over, at least five runs with alternating high-positive and negative specimens
shall be performed during robustness studies. The high positive samples shall comprise of samples with naturally
occurring high virus titres.

The whole system failure rate leading to false-negative results shall be determined by testing low-positive
specimens. Low positive specimens shall contain a virus concentration equivalent to three times the 95 %
positive cut-off virus concentration.

CTS for the manufacturer’s release testing of reagents and reagent products for the detection, con-
firmation and quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTLV I and
II, and hepatitis B, C, D (Immunological assays only)

3.4.1.

The manufacturers release testing criteria shall ensure that every batch consistently identifies the relevant
antigens, epitopes, and antibodies.

3.4.2.

The manufacturer’s batch release testing for screening assays shall include at least 100 specimens negative for the
relevant analyte.

3.5.

CTS for performance evaluation of reagents and reagent products for determining the following blood
group antigens: ABO blood group system ABO1 (A), ABO2 (B), ABO3 (A,B); Rh blood group system
RH1 (D), RH2 (C), RH3 (E), RH4 (c), RH5 (e); Kell blood group system KEL1 (K)

Criteria for performance evaluation of reagents and reagent products for determining the blood groups antigens:
ABO blood group system ABO1 (A), ABO2 (B), ABO3 (A,B); Rh blood group system RH1 (D), RH2 (C), RH3 (E),
RH4 (c), RH5 (e); Kell blood group system KEL1 (K) can be found in Table 9.

3.5.1. All performance evaluations shall be carried out in direct comparison with an established state-of-the-art device.
if on the market at the time of the

The device used for comparison shall be one bearing CE marking,
performance evaluation.

3.5.2.

If discrepant test results are identified as part of an evaluation, these results shall be resolved as far as possible,
for example:

— by evaluation of the discrepant sample in further test systems,

— by use of an alternative method,

3.5.3.

Performance evaluations shall be performed on a population equivalent to the European population.

3.5.4.

Positive specimens used in the performance evaluation shall be selected to reflect variant and weak antigen
expression.

3.5.5. Devices shall be evaluated to establish the effect of potential interfering substances, as part of the performance
evaluation. The potential interfering substances to be evaluated will depend to some extent on the composition
of the reagent and configuration of the assay. Potential interfering substances shall be identified as part of the
risk analysis required by the essential requirements for each new device.

3.5.6.

3.6.

3.6.1.

For devices intended for use with plasma the performance evaluation shall verify the performance of the device
using all anticoagulants which the manufacturer indicates for use with the device. This shall be demonstrated for
at least 50 donations.

CTS for the manufacturers release testing of reagents and reagent products for determining the blood
group antigens: ABO blood group system ABO1 (A), ABO2 (B), ABO3 (A,B); Rh blood group system
RH1 (D), RH2 (C), RH3 (E), RH4 (c), RH5 (e); Kell blood group system KEL1 (K)
The manufacturer’s release testing criteria shall ensure that every batch consistently identifies the relevant
antigens, epitopes, and antibodies.

3.6.2.

Requirements for manufacturers batch release testing are outlined in Table 10.

L 39/40

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EN

Official Journal of the European Union

10.2.2009

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EN

Official Journal of the European Union

L 39/47

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L 39/48

EN

Official Journal of the European Union

10.2.2009

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10.2.2009

EN

Official Journal of the European Union

L 39/49

Table 10

Batch release criteria for reagents and reagent products to determine blood group antigens in the ABO, Rh and
Kell blood group systems

Specificity Testing Requirements on each reagent

1. Test reagents

Blood Group Reagents

Minimum number of control cells to be tested

Positive reactions

Negative reactions

Anti-ABO1 (anti-A)

Anti-ABO2 (anti-B)

Anti-ABO3 (anti-A,B)

Anti-RH1 (anti-D)

Anti-RH2 (anti-C)

Anti-RH4 (anti-c)

Anti-RH 3 (anti-E)

Anti-RH5 (anti-e)

Anti-KEL1 (anti-K)

A2B

2

A1B

2

A2

2

Ax

2 (*)

Ax

2

R2r

WeakD

B

2

2

R1r

1

R1r

2

R2r

1

R2r

1

2 (*)

r’r

1

r’r

1

r’’r

1

r’’r

1

A1

2

B

2

A1

2

R1r

2

R1R2

2

R1R2

1

R1R2

2

R1R2

2

Kk

4

0

2

0

2

r’’r

1

r’’r

1

r’r

1

B

2

A1

2

0

4

r’r

1

R2R2

1

R1R1

3

R1R1

1

R2R2

3

kk

3

rr

1

rr

1

rr

1

(*) Only by recommended techniques where reactivity against these antigens is claimed.

Note: Polyclonal reagents must be tested against a wider panel of cells to confirm specificity and exclude presence of unwanted

contaminating antibodies.

Acceptance Criteria:

Each batch of reagent must exhibit unequivocal positive or negative results by all recommended techniques in
accordance with the results obtained from the performance evaluation data.

2. Control Materials (red Cells)

The phenotype of red cells used in the control of blood typing reagents listed above should be confirmed using
established device.’