Klein v Commission (Non-contractual liability - Medical devices - Opinion)

(Appeal — Non-contractual liability — Directive 93/42/EEC — Articles 8 and 18 — Medical devices — Inaction by the Commission following notification of a decision to prohibit placing on the market — Safeguard clause procedure — Sufficiently serious breach of a rule of law conferring rights on individuals — Causal link — Actual and certain damage)

By his appeal, Mr Christoph Klein seeks to have set aside the judgment of the General Court of the European Union of 28 September 2016, Klein v Commission (T‑309/10 RENV, not published, ‘the judgment under appeal’, EU:T:2016:570 ), whereby the General Court dismissed his action for compensation for the harm alleged to have been sustained following a breach by the European Commission of its obligations under Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. ( 2 )

Examination of this appeal, limited to the fifth ground of appeal, in accordance with the Court’s request, will lead me to explain the reasons why I consider that this ground of appeal is well founded and that, accordingly, the judgment under appeal must be set aside in part.

‘1. This Directive shall apply to medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as medical devices in their own right. Both medical devices and accessories shall hereinafter be termed devices.

(a) “medical device” means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of: