Case C-489/06: Action brought on 27 November 2006 — Commission of the European Communities v Hellenic Republic
Date: 2006-12-30
Institutions: Court of Justice
Subjects: Community certification, EC conformity marking, European Commission, Greece, action for failure to fulfil an obligation, award of contract, invitation to tender, medical device, supplies contract

C 326/50

EN

Official Journal of the European Union

30.12.2006

Form of order sought

Pleas in law and main arguments

The applicant claims that the Court should:

— declare that, by failing to adopt the laws, regulations and
administrative provisions necessary to implement Council
Directive 2002/90/EC of 28 November 2002 defining the
facilitation of unauthorised entry, transit and residence (1),
or, in any event, by not communicating those provisions to
the Commission, the Federal Republic of Germany has failed
to fulfil its obligations under that directive;

— order the Federal Republic of Germany to pay the costs.

Pleas in law and main arguments

The period for
December 2004.

implementing the Directive expired on 5

(1) OJ 2002 L 328, p. 17.

Action brought on 27 November 2006 — Commission of
the European Communities v Hellenic Republic

(Case C-489/06)

(2006/C 326/102)

Language of the case: Greek

Parties

Applicant: Commission of the European Communities (repre-
sented by: M. Patakia and X. Lewis)

Defendant: Hellenic Republic

Form of order sought

— declare that, by rejecting tenders in respect of medical
devices bearing the CE certification marking, without, in any
event, the competent contracting authorities of Greek hospi-
tals having followed the procedure set out
in Directive
93/42/EEC, the Hellenic Republic has failed to fulfil its obli-
gations under Article 8(2) of Directive 93/36/EEC of 14
June 1993 (1) coordinating procedures for the award of
public supply contracts and Articles 17 and 18 of Council
Directive 93/42/EEC of 14 June 1993 (2)
concerning
medical devices;

— order the Hellenic Republic to pay the costs.

The Commission received a complaint relating to the phenom-
enon of rejection of medical devices, in the context of calls for
competition for supplies to public hospitals in Greece, on
grounds relating to the ‘general sufficiency and safety of use’
thereof, notwithstanding their certification with the CE marking,
and without, in any event, the procedure provided for in Direc-
tive 93/42/EEC concerning medical devices being followed.

Under Directive 93/36/EEC coordinating procedures for the
award of public supply contracts, the tender procedures must be
conducted on the basis of the relevant national technical stan-
dards implementing European standards, of European technical
approvals or of common technical specifications. The Commis-
sion considers that, by deciding in the instances at issue that the
CE marking did not constitute an appropriate and binding guar-
antee of the suitability of the products in the tenders, without
any of the prescribed exceptions which justify divergence from
the directive's provisions being applicable, the Greek contracting
authorities infringed the obligations owed by them in that
regard under Article 8(2).

At the same time, the Commission points out an infringement
of Directive 93/42/EEC concerning medical devices, which lays
down specific and exclusive procedures for certifying such
devices and placing them on the market, as well as for
contesting their suitability. The information available to the
Commission reveals continual breach, by the competent Greek
authorities which have rejected tenders, of the legal procedures
for checking the suitability of medical devices. None of the
stages of the procedure provided for in Article 18 of the direc-
tive was observed where the correctness of certification —
pursuant to Article 17 of the directive — with the CE marking
was disputed.

Also,
in the Commission's submission, the Greek authorities'
claim that the measures which they have taken to eliminate the
abovementioned phenomenon are sufficient is contradicted by
the very facts and, in any event, in accordance with the Court of
Justice's case-law, the existence of national procedures which are
designed to deal with every infringement relating to public
procurement does not justify infringement of the relevant Com-
munity rules by the Member State.

The Commission considers therefore that the Hellenic Republic
has infringed its obligations under Directive 93/36/EEC, in par-
ticular Article 8(2), and under Directive 93/42/EEC, in particular
Articles 17 and 18.

(1) OJ No L 199, 9.8.1993, p. 1.
(2) OJ No L 169, 12.7.1993, p. 1.