European Commission Cracks Down on Medical Device Anti-Trust Activity

The European Commission appears to be cracking down on antitrust activity in the medical device industry in the form of surprise inspections.

This week the Commission reported that it is carrying out unannounced inspections at the premises of an undisclosed company that makes medical devices for cardiovascular applications. These inspections were prompted by concerns that the company in question may have violated EU antitrust rules that prohibit abuses of a dominant market position.

In particular, the Commission pointed to Article 102 of the Treaty on the Functioning of the European Union, which prohibits companies from directly or indirectly imposing unfair purchase or selling prices or other unfair trading conditions; limiting production, markets, or technical development to the prejudice of consumers; applying dissimilar conditions to equivalent transactions with other trading parties, thereby placing them at a competitive disadvantage; and making the conclusion of contracts subject to acceptance by the other parties of supplementary obligations which, by their nature or according to commercial usage, have no connection with the subject of such contracts.

The Commission officials were accompanied by their counterparts from the national competition authority of the Member State where the inspection was carried out. The location of the company in question was not disclosed.

Unannounced inspections are a preliminary investigative step into suspected anticompetitive practices and does not mean the company in question is guilty of anti-competitive behavior, nor does it prejudge the outcome of the investigation itself, the Commission noted. Companies have the right to be heard in antitrust proceedings.

The Commission also said there is no legal deadline to complete inquiries into anticompetitive conduct. Their duration depends on a number of factors, including the complexity of each case, the extent to which the companies concerned cooperate with the Commission, and the parties' exercise of their rights of defense.