Case C-6/05: Judgment of the Court (First Chamber) of 14 June 2007 (reference for a preliminary ruling from the Simvoulio tis Epikratias, Greece) — Medipac-Kazantzidis AE v Venizelio-Pananio (PE.S.Y. KRITIS) (Free movement of goods — Directive 93/42/EEC — Hospital purchase of medical devices bearing the CE marking — Protective measures — Public supply contract — Contract falling below the threshold of application of Directive 93/36/EEC — Principle of equal treatment and obligation of transparency)
Date: 2007-08-04
Institutions: Court of Justice
Subjects: EC conformity marking, Greece, free movement of goods, interpretation of the law, invitation to tender, market approval, medical device, public health, supplies contract

C 183/2

EN

Official Journal of the European Union

4.8.2007

V

(Announcements)

COURT PROCEEDINGS

COURT OF JUSTICE

Judgment of the Court (First Chamber) of 14 June 2007
(reference for a preliminary ruling from the Simvoulio
tis Epikratias, Greece) — Medipac-Kazantzidis AE v
Venizelio-Pananio (PE.S.Y. KRITIS)

Operative part of the judgment

(Case C-6/05) (1)

(Free movement of goods — Directive 93/42/EEC — Hospital
purchase of medical devices bearing the CE marking —
Protective measures — Public supply contract — Contract
falling below the
threshold of application of Directive
93/36/EEC — Principle of equal treatment and obligation of
transparency)

(2007/C 183/02)

Language of the case: Greek

Referring court

Simvoulio tis Epikratias

Parties to the main proceedings

Applicant: Medipac-Kazantzidis AE

Defendant: Venizelio-Pananio (PE.S.Y. KRITIS)

Re:

for

the

Reference for a preliminary ruling — Symvoulio tis Epikrateias
— Interpretation of Council Directive 93/36/EEC of 14 June
award of public
1993 coordinating procedures
supply contracts (OJ 1993 L 199, p. 1) and Council Directive
93/42/EEC of 14 June 1993 concerning medical devices
(OJ 1993 L 169, p. 1) — Rejection of a tender concerning
products bearing the CE marking — Insufficiency of
the
products in terms of their quality, having regard to the protec-
tion of public health and the particular use for which they are
intended — Procedure for the supply of medical devices to a
hospital

1) The principle of equal treatment and the obligation of transparency
preclude a contracting authority, which has issued an invitation to
tender for the supply of medical devices and specified that those
devices must comply with the European Pharmacopoeia and bear
the CE marking, from rejecting, directly and without following the
safeguard procedure provided for in Articles 8 and 18 of Council
Directive 93/42/EEC of 14 June 1993 concerning medical devices,
as amended by Regulation (EC) No 1882/2003 of the European
Parliament and of the Council of 29 September 2003, on grounds
of protection of public health,
they
comply with the stated technical requirement. If the contracting
those materials may jeopardise public
authority considers that
health, it is required to inform the competent national authority
with a view to setting that safeguard procedure in motion.

the materials proposed,

if

2) A contracting authority, which has referred a matter to the compe-
tent national authority with a view to setting in motion the safe-
guard procedure provided for by Articles 8 and 18 of Directive
93/42, as amended by Regulation No 1882/2003, concerning
medical devices bearing the CE marking, is required to suspend the
tendering procedure until the end of that safeguard procedure, the
contracting
that procedure being binding on the
outcome of
authority. If the implementation of such a safeguard procedure gives
rise to delays liable to jeopardise the operation of a public hospital
and thereby public health, the contracting authority is entitled to
take all interim measures required to enable it to procure the mate-
rials necessary for the smooth running of that hospital, subject to
compliance with the principle of proportionality.

(1) OJ C 69, 19.3.2005.