Case T‑309/10

Christoph Klein

v

European Commission

‛Non-contractual liability — Medical devices — Articles 8 and 18 of Directive 93/42/EEC — Inaction by the Commission following notification of a decision to prohibit placing on the market — Sufficiently serious breach of a rule of law conferring rights on individuals’

Summary — Judgment of the General Court (First Chamber), 21 January 2014

Non-contractual liability — Conditions — Unlawful conduct of the institutions — Commission not initiating the safeguard procedure under Directive 93/42 of its own motion — Act not amounting to unlawfulness — Exclusive competence of the Member States to initiate the procedure

Non-contractual liability — Conditions — Unlawful conduct of the institutions — Inaction by the Commission following notification of a decision to prohibit placing of a medical device on the market — Act not amounting to unlawfulness

In a case of continuing damage, the limitation period referred to in Article 46 of the Statute of the Court applies, by reference to the date of the event which interrupted the limitation period, to the period preceding that date by more than five years and does not affect any rights arising during subsequent periods. (see para. 52)

In order for the Union to incur non-contractual liability under the second paragraph of Article 340 TFEU for unlawful conduct of its institutions, a number of cumulative conditions must be satisfied: the institution’s conduct must be unlawful, actual damage must have been suffered and there must be a causal link between the conduct and the damage pleaded. As regards the condition relating to the unlawfulness of the alleged conduct of the institution or body concerned, case-law requires there to be established a sufficiently serious breach of a rule of law intended to confer rights on individuals. In relation to the requirement for the breach to be sufficiently serious, the decisive criterion for establishing this is whether the Union institution or body in question manifestly and gravely disregarded the limits on its discretion. Where that institution or body only possesses a considerably reduced discretion, or even none at all, the mere infringement of Union law may be sufficient to establish the existence of a sufficiently serious breach. (see paras 56, 57)

See the text of the decision. (see paras 58-60)

In so far as Article 8(3) of Directive 93/42 concerning medical devices establishes only an obligation on the Member State to inform the Commission of a prohibition decision, and not an obligation on the Commission to act, the Commission is not required to adopt any decision following receipt of notification. That conclusion cannot be called into question by the fact that the notification refers, in its heading, to the safeguard clause procedure provided for in Article 8 of that directive. The legal effect of any administrative act must always be examined in terms of its substance rather than its formal appearance. Consequently, however regrettable it might be that the Commission makes no reaction to notification by the authorities of a Member State of a prohibition decision, no illegal conduct by the Commission can be deduced from the fact that it does not adopt a decision under Article 8(2) of Directive 93/42 following the said notification. Moreover, a white paper cannot constitute the legal basis for an obligation on the part of the Commission, since it is only a document containing proposed actions of the Union and is a communication intended to launch political debate and not to create legal obligations. (see paras 77-79, 84-86)

No illegal conduct on the part of the Commission can be deduced from the fact that it has not commenced a safeguard clause procedure under Article 8(2) of Directive 93/42 concerning medical devices. Pursuant to Article 8(1) of that directive, it is for Member States to take necessary measures so that medical devices cannot be placed on the market if they compromise the safety and health of patients. In these circumstances, the directive provides for a system in which market surveillance falls to the national authorities and not the Commission. In addition, according to Article 8 of Directive 93/42, initiating a safeguard clause procedure falls entirely within the remit of the Member States, so that they are the only ones who can commence the said procedure. In this regard, it must be held that Article 8 of Directive 93/42 does not provide for the Commission, of its own initiative, to inform Member States of its findings in relation to national measures. Moreover, in accordance with the principle of division of powers enshrined in Article 5(2) of the TEU, the Union shall only act within the limits of the competences conferred upon it by the Member States in the Treaties to attain the objectives set out therein. Therefore, the Commission cannot act outside the competences thus established by Directive 93/42 by initiating the safeguard clause procedure of its own motion and cannot be criticised for that on the grounds of effectiveness. (see paras 89, 90, 96)