Case C-6/05: Reference for a preliminary ruling from the Simvoulio tis Epikratias by decision of that court of 17 November 2004 in Medipac — Th. Kazantzidis A.E. v Venizelio-Pananio (PE.S.I. Kritis)
Date: 2005-03-19
Institutions: Court of Justice
Subjects: EC conformity marking, Greece, interpretation of the law, invitation to tender, market approval, medical device, public health, supplies contract

19.3.2005

EN

Official Journal of the European Union

C 69/7

Reference for a preliminary ruling from the Simvoulio tis
Epikratias by decision of that court of 17 November 2004
in Medipac — Th. Kazantzidis A.E. v Venizelio-Pananio
(PE.S.I. Kritis)

(Case C-6/05)

(2005/C 69/14)

(Language of the case: Greek)

Reference has been made to the Court of Justice of the Euro-
pean Communities by decision of the Simvoulio tis Epikratias
(Council of State, Greece) of 17 November 2004, received at
the Court Registry on 5 January 2005, for a preliminary ruling
in the proceedings between Medipac — Th. Kazantzidis A.E.
and Venizelio-Pananio (PE.S.I. Kritis) on the following ques-
tions:

(1) Whenever tender procedures governed by Council Directive
93/36/EEC for the supply of medical devices under Direc-
tive 93/42/EEC are conducted under the lowest-tender
system, is the contracting authority as the purchaser of the
relevant goods able,
in accordance with Directive 93/42,
interpreted in conjunction with Directive 93/36, to reject a
tender for medical devices which bear the CE marking and
have been the subject of a quality check by the competent
certification body, as technically unacceptable at the stage
of the technical assessment, in reliance upon sound objec-
tions relating to their adequacy in terms of quality which
are connected with the protection of public health and the
specific form of use for which those devices are intended
and in view of which objections the devices are considered
inappropriate and unfit for that use (with the self-evident
precondition that those objections are subject to review of
their validity by the court having jurisdiction if there is a
dispute as to whether they pertain)?

Decree DI7/ik.2480/1994 and which enable the relevant
competent authority – which in Greece is the Ministry of
Health, Welfare and Social Security acting through the
Directorate for Biomedical Technology – to take measures
either in accordance with the procedure in Article 8 of the
directive,
if correctly installed and maintained medical
devices may jeopardise the life or safety of patients or
users, or under Article 18 of the directive, if it is established
that the CE marking has been affixed unduly?

(3) In light of the answer to the second question, and in the
event that the abovementioned safeguard clauses must first
be applied, is the contracting authority obliged to await the
outcome of the procedure initiated either under Article 8
or under Article 18 of Directive 93/42 and, further, is it
bound by that outcome in the sense that it is obliged to
procure the article in question even though its use demon-
strably gives rise to risks for public health and generally it
is unsuitable for the use for which the contracting authority
intends it?

Reference for a preliminary ruling from the Cour Admin-
istrative (Grand Duchy of Luxembourg) by judgment of
that court of 11 January 2005 in Cynthia Mattern and
Hajrudin Cikotic v Ministre du travail et de l'emploi

(Case C-10/05)

(2005/C 69/15)

(Language of the case: French)

(2) If the preceding question is answered in the affirmative, is
the contracting authority as the purchaser of the relevant
goods able, for the foregoing reason, directly to consider
medical devices which bear the CE marking unsuitable for
the form of use for which they are intended, or must the
safeguard clauses first be applied which are contained in
Directive 93/42 and the abovementioned Joint Ministerial

Reference has been made to the Court of Justice of the Euro-
pean Communities by judgment of the Cour administrative
(Higher Administrative Court) (Grand Duchy of Luxembourg)
of 11 January 2005, received at the Court Registry on 14
January 2005,
for a preliminary ruling in the proceedings
between Cynthia Mattern and Hajrudin Cikotic and the Ministre
du travail et de l'emploi on the following question: