2008/932/EC: Commission Decision of 2 December 2008 on the application of Article 8 of Directive 98/79/EC of the European Parliament and of the Council (notified under document number C(2008) 7378)
Date: 2008-12-02
Institutions: European Commission
Subjects: European standard, harmonisation of standards, medical device, medical diagnosis

11.12.2008

EN

Official Journal of the European Union

L 333/5

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

II

DECISIONS

COMMISSION

COMMISSION DECISION

of 2 December 2008

on the application of Article 8 of Directive 98/79/EC of the European Parliament and of the Council

(notified under document number C(2008) 7378)

(Only the Portuguese text is authentic)

(2008/932/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

report is identical to the NCAR report DE-2005-07-27-
30.

(3)

(4)

Having regard to the Treaty
Community,

establishing the European

regard to Directive 98/79/EC of

Having
the European
Parliament and of the Council of 27 October 1998 on in-
vitro diagnostic medical devices (1), and in particular Article 8
thereof,

Whereas:

(1)

(2)

The Portuguese medical device authority Infarmed has, by
letter of 29 July 2005 (2) addressed to the Italian
company Medical Biological Service SRL (hereafter
MBS), forbidden the marketing of their HIV in-vitro diag­
nostic test kit ‘HIV 1 & 2 Ab’ (hereafter the HIV test).
Infarmed also obliged the Portuguese distributor Pres­
tifarma Lda to recall the product on behalf of MBS.

By letter of 1 September 2005 (3) Infarmed notified these
measures under Article 13 of Directive 98/79/EC. As
justification for their measure Portugal referred to the
German Paul-Ehrlich-Institut’s health surveillance report
‘NCAR DE-2005-07-30’
(PEI Case No PEI0026/05). A
subsequent exchange of letters clarified that the NCAR
the correct NCAR
reference was misquoted and that
this
report number was DE-2005-07-07-30 and that

The NCAR report DE-2005-07-07-30 states that, shortly
after an HIV infection, the HIV test needs 10 to 18 days
more than comparable tests to detect the infection (low
early sero-conversion sensitivity). For the same reason,
the Slovak Medical University had, in its test report of
28 October 2004 (4), recommended the Slovak notified
body EVPÚ not to certify the HIV test. The test did thus
not fulfil the requirement of being conform to the ‘state
of
(Essential
in the meaning of Annex I
requirements) section A.2 of Directive 98/79/EC and
section 3.1.8, third sentence, of the Common technical
specifications
in-vitro diagnostic medical devices
annexed to Commission Decision 2002/364/EC of
7 May 2002 on common technical specifications for
in-vitro diagnostic medical devices (5).

the art’

for

to

the

in its
Moreover, as stated by the Paul-Ehrlich-Institut
of
of Health
the German Ministry
letter
12 December 2005 (6),
documentation made
available by the manufacturer shows that the HIV test
did not detect all true positive samples, as required by
3.1.8, first sentence, of the Common technical specifi­
cations. This failure has never been explained by the
manufacturer or his notified body as
required by
paragraph 3.1.5 of the Common technical specifications.
Thus the HIV test does not fulfil sections 3.1.8, first
sentence, and 3.1.5 of the Common technical specifi­
cations.

(1) OJ L 331, 7.12.1998, p. 1.
(2) DGREE/VPS/086/05 — Case No 9.5.1 — 329/2005.
(3) DGREE/VPS/094/05.

(4) Test report No E-650/04 208600.
(5) OJ L 131, 16.5.2002, p. 17.
(6) Reference No A2.

L 333/6

EN

Official Journal of the European Union

11.12.2008

(5)

(6)

(7)

(8)

MBS modified the HIV test after taking note of the NCAR
report DE-2005-07-07-30. However,
the modification
did not improve the early sero-conversion sensitivity of
the HIV test, as stated by the Paul-Ehrlich-Institut later in
a report of 23 August 2007 (1). As stated on page 10 of
this report, the modified test also fails to detect samples
already confirmed as true positive by Western blot or
immunoblot assays.

The Commission consulted the Member States by letter
of 22 March 2007 (D(2007) 7800), the involved notified
bodies and institutes by letter of 21 March 2007
(D(2007) 7817), and MBS by letter of 11 June 2007
It furthermore consulted experts in
(D(2007) 16597).
in-vitro diagnostic medical devices on
the
field of
various occasions and,
in a meeting on
31 January 2008.

inter alia,

Article 13 of Directive 98/79/EC (Particular health moni­
toring measure) has wider conditions than Article 8
this Directive. Article 13 of
(Safeguard clause) of
Directive 98/79/EC does not require the same level of
certainty of
the acting authority with regard to the
existence of a risk.

The analysis of the initial notification and of the later
correspondence of Infarmed and the consultation of the
parties concerned have shown that that it can be ascer­
tained that the device under examination, when correctly
maintained and used for
its intended purpose, may
compromise the health and/or the safety of patients,
users or other persons, in the meaning of Article 8 of
Directive 98/79/EC, as the essential requirement of being
‘state of the art’ is not met.

(9)

As the test is slower and less reliable than other devices,
it will detect less HIV infections than the other devices
and may delay the start of an adequate anti-retroviral
therapy. The test could also contribute to an increased
It also
risk of missing HIV infected blood donors.
compromises health in as much as its late and poor
detection of the HIV infection may increase the risk of
transmission to third persons,
for instance by sexual
intercourse.

(10) According to the European Court of Justice (2) the view
given by the European Commission in accordance with
Article 8.2 of Directive 98/79/EC binds the Member State
which has taken measures. Accordingly, this legal act is
to be qualified as a decision,

HAS ADOPTED THIS DECISION:

Article 1

The measures of the Portuguese authority Infarmed taken by
letter of 29 July 2005 (DGREE/VPS/086/05 — Case No 9.5.1
— 329/2005) against the marketing of the in-vitro diagnostic
medical device ‘HIV 1 & 2 Ab’ manufactured by the Italian
company Medical Biological Service SRL are justified.

This Decision is addressed to the Portuguese Republic.

Article 2

Done at Brussels, 2 December 2008.

For the Commission

Günter VERHEUGEN
Vice-President

(1) Austrian authorities had asked the Paul-Ehrlich-Institut

this
report after confiscating the modified test on the way from MBS
to the Austrian company Dialab GmbH,
the latter intending to
market the test under its own name.

for

(2) See, by analogy, Judgment of the Court (First Chamber) of 14 June

2007, Case C-6/05, ECR 2007, p. I-4557 Nos 58, 59.