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)

• Published date: 10 February 2009
• Date of Signature: 22 October 2009
• Subject Matter: Technical barriers,Approximation of laws,public health,Internal market - Principles
• Official Gazette Publication: Official Journal of the European Union, L 39, 10 February 2009

10.2.2009 EN Official Journal of the European Union L 39/34

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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 establishing the European Community,

Having regard to Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro-diagnostic medical devices (1), and in particular the second subparagraph of Article 5(3) thereof,

Whereas:

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

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

(3) 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.

(4) To bring the common technical specifications in line with current scientific and technical practices it is necessary to update a number of scientific and technical references.

(5) The requirements for HIV screening assays should be clarified. In order to ensure that the performance 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.

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

(7) 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.

(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),

HAS ADOPTED THIS DECISION:

Article 1

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

Article 2

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.

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.

Article 3

This Decision is addressed to the Member States.

Done at Brussels, 3 February 2009.

For the Commission

Günter VERHEUGEN

Vice-President

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(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.

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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.

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

3.1. 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. The device used for comparison shall be one bearing CE marking, if on the market at the time of the 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.

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...