Action brought on 2 May 2007 - Portela - Comércio de artigos ortopédicos e hospitalares v Commission

(Case T-137/07)

Language of the case: Portuguese

Parties

Applicant: Portela - Comércio de artigos ortopédicos e hospitalares, Lda. (Queluz, Portugal) (represented by: C. Mourato, lawyer)

Defendant: the Commission of the European Communities

Form of order sought

that the Court of First Instance should impose on the Commission the obligation to act in accordance with Article 14b of Council Directive 93/42/EEC of 14 June 1993, ¹ in particular by requiring the notified body, through the German State, to activate the civil liability insurance provided for in point 6 of Annex XI to Directive 93/42 of 14 June and in point 7(a) of the document MEDDEV 2.10-2 Rev 1 April 2001, so as to indemnify the applicant for the damage sustained;

or, in case the applicant is not indemnified for the damage sustained by means of that compulsory civil liability insurance, an order that the Commission should pay the applicant the sum of EUR 2 419 665.42 as compensation for the damage sustained;

an order that the Commission should pay the applicant default interest calculated on the basis of the reference rate of the European Central Bank, increased by two percentage points, from the date this action was lodged;

an order that the Commission should pay the costs, in accordance with Article 87(2) of the Rules of Procedure of the Court of First Instance, in particular expenses necessarily incurred by the applicant for the purpose of the proceedings, in particular the travel and subsistence expenses and the remuneration and expenses of lawyers, in accordance with Article 91(b) of those Rules.

Pleas in law and main arguments

In carrying on its commercial activity, the applicant, a commercial company with its seat in Portugal, imported from Taiwan in the first half of 2002 two batches of 5 184 digital thermometers manufactured by the undertaking Geon Corporation ('Geon') which proved to be faulty.

Geon's system of quality control was monitored by the TÜV Rheinland (Technischer Überwachungs-Verein, Technical Monitoring Association of the Rhineland) which, as the notified body responsible for that process, was under a legal duty to carry out adequate inspections and assessments for the purpose of making sure that the manufacturer applied the approved quality system, possibly making unannounced visits to the manufacturer during which it could, if necessary, carry out or ask for tests in order to check that the quality control system worked properly, in accordance with Articles 4.2 and 4.3 of Annex V to the Directive.

The notified body in question, TÜV Rheinland, was unable to ensure that the product it certified was fit to be marketed safely in Europe, being unwilling also to assume its repsonsibilities when alerted by the applicant to the serious problems caused by that product.

That body thus infringed point 4 of Annex V to the Directive and points 1, 2 and 4, in particular 4.1, 4.3 and 4.4 of Module D (production quality assurance) in Council Decision 93/465/EEC of 22 July 1993. ²

The procedure to be adopted by the Commission and the Member States when any doubt arises as to the competence of a notified body consists, as stated in the first subparagraph of point 6.2.2. of the Guide to the implementation of directives based on the new approach and the global approach, in reassessing that body's ability to undertake the actions for which it was notified.

It fell within the Commission's powers to require the competent German authority, in accordance with point A, Chapter I of the Annex to Decision 93/465, to take appropriate measures as provided for by the document MEDDEV 2.10-2 Rev 1 of April 2001, it being obliged to act with regard to the body it had itself designated.

For circumstances such as those of the present case, in which there transpires a fault in the procedure for assessing the production quality of the undertaking in question which leads to the placing on the market of goods that are not in conformity with requirements and that pose a threat to the health of consumers, as happened, point 6 of Annex XI to the Directive provides that the notified body must take out civil liability insurance to be activated when any accident occurs, covering in particular those cases in which the notified body is obliged to withdraw or suspend certificates, as is also provided by point 7 of document MEDDEV 2.10-2 Rev 1.

Regardless of the responsibilities of the national bodies entrusted with surveillance of the market in the examination of the notified body's competence, and despite the fact that the Commission may not act directly in respect of that notified body, it fell to the Commission, automatically advised of the serious problem that had arisen, to act together with the Member State in whose territory the body in question had its headquarters, obliging it to take the corrective measures necessary in order that the safety and health of European citizens might be assured, in accordance with Article 152(1) of the EC Treaty.

The applicant requested only that the Commission should oblige the competent German national authority, the BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte, the Federal Institute for Drugs and Medical Devices), through the German State, to make use of the civil liability insurance provided for by law, so allowing the applicant to be compensated for the damage caused by the placing on the market of goods carrying the EC marking when they were not in fact in conformity.

Point 8.3.3 of the Guide states that 'The Commission is responsible for administering the safeguard clause at Community level, and for ensuring that it applies to the whole of the Community.'

Infarmed (Instituto Nacional da Farmácia e do Medicamento, the National Institute of Pharmacy and Medicine) suspended the marketing in Portugal of the goods in question and ordered them to be withdrawn in accordance specifically with Article 14b of the Directive.

The Commission thus infringed the following provisions of law: Article 152(1) of the EC Treaty, Article 14b of Directive 93/42, points 6.2.2, first paragraph, 8.2.2, 8.2.3., 8.3.2 and 8.3.3 of the Guide to the implementation of directives based on the new approach and the global approach and point 1, Chapter I, of the Annex to Decision 93/465.

By failing to fulfil its obligations under the abovementioned provisions of law, the Commission has prevented the applicant from being compensated for the loss sustained by means of recourse to the abovementioned compulsory civil liability insurance.

The applicant had expected to sell at least 500 000 thermometers a year.

From the moment the decision was taken to withdraw those goods from the market, the doors of that market were closed to the applicant, since its image was irreparably associated with the non-conformity [with the requirements] of the goods it had placed on the market.

The damage suffered by the applicant amounts to a total of EUR 2 419 665.42.

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¹ - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ 1993 L 169, p. 1).

² - OJ 1993 L 220, p. 23.