# C_2009102EN.01001601.xml

| 1.5.2009 | EN | Official Journal of the European Union | C 102/16 |
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1.5.2009

EN

Official Journal of the European Union

C 102/16

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Appeal brought on 27 February 2009 by Portela — Comércio de artigos ortopédicos e hospitalares, Lda against the order made by the Court of First Instance on 17 December 2008 in Case T-137/07 Portela — Comércio de artigos ortopédicos e hospitalares, Lda v Commission of the European Communities

da

da

(Case C-85/09 P)

2009/C 102/26

Language of the case: Portuguese

Parties

Parties

Appellant: Portela — Comércio de artigos ortopédicos e hospitalares, Lda (represented by C. Mourato, advogado)

Appellant:

da

Other party to the proceedings: Commission of the European Communities

Other party to the proceedings:

Form of order sought

Form of order sought

The appellant claims that the Court should:

| — | set aside, in part, the order under appeal in so far as it considered that no causal connection had been established between the Commission’s failure to act and the damage allegedly sustained (paragraphs 96, 97, 99, 100 and 101 of the order under appeal) by the appellant; |
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set aside, in part, the order under appeal in so far as it considered that no causal connection had been established between the Commission’s failure to act and the damage allegedly sustained (paragraphs 96, 97, 99, 100 and 101 of the order under appeal) by the appellant;

and, ruling on the merits,

| — | declare, primarily, that in this case the conditions necessary for the Commission to incur non-contractual liability have been satisfied; order the Commission to pay compensation for the damage alleged, and order the Commission to pay all the costs at both instances, including the appellant’s; |
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declare, primarily, that in this case the conditions necessary for the Commission to incur non-contractual liability have been satisfied; order the Commission to pay compensation for the damage alleged, and order the Commission to pay all the costs at both instances, including the appellant’s;

| — | or, refer the case back to the Court of First Instance for it to ascertain whether the conditions necessary for the Commission to incur non-contractual liability have been satisfied; order the Commission to pay compensation for the damage alleged, and order the Commission to pay the costs — including the appellant’s — of these proceedings and of those before the Court of First Instance. |
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or, refer the case back to the Court of First Instance for it to ascertain whether the conditions necessary for the Commission to incur non-contractual liability have been satisfied; order the Commission to pay compensation for the damage alleged, and order the Commission to pay the costs — including the appellant’s — of these proceedings and of those before the Court of First Instance.

Pleas in law and main arguments

Pleas in law and main arguments

| — | The order under appeal is insufficiently reasoned, for the Court of First Instance has not answered the arguments raised by the appellant, in paragraphs 92 and 93 of the original application, to the effect that the fact that the manufacturer had no authorised representative for Community territory, as required by the directive, rendered impossible the conformity assessment procedure carried out by the notified body and, lastly, concerning the Commission’s assertion that it had not been called upon to take part in the safeguard procedure because the Portuguese authority Infarmed had failed to act in accordance with Article 14b of Council Directive 93/42/EC (1) of 14 June 1993 concerning medical devices, as amended by Directive 98/79/EC (2) of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices; |
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The order under appeal is insufficiently reasoned, for the Court of First Instance has not answered the arguments raised by the appellant, in paragraphs 92 and 93 of the original application, to the effect that the fact that the manufacturer had no authorised representative for Community territory, as required by the directive, rendered impossible the conformity assessment procedure carried out by the notified body and, lastly, concerning the Commission’s assertion that it had not been called upon to take part in the safeguard procedure because the Portuguese authority Infarmed had failed to act in accordance with Article 14b of Council Directive 93/42/EC (1) of 14 June 1993 concerning medical devices, as amended by Directive 98/79/EC (2) of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices;

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in vitro

| — | error in the assessment of the causal connection between the Commission’s conduct and the damage suffered by the appellant and misinterpretation of Articles 8 and 14b of the Directive by the Court of First Instance; |
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error in the assessment of the causal connection between the Commission’s conduct and the damage suffered by the appellant and misinterpretation of Articles 8 and 14b of the Directive by the Court of First Instance;

| — | infringement of the right to a fair hearing by refusing the measures of inquiry sought by the appellant. |
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infringement of the right to a fair hearing by refusing the measures of inquiry sought by the appellant.

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(1)  OJ 1993 L 169, p. 1.

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(2)  OJ 1998 L 331, p. 1.

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