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Document 62011CA0219

Case C-219/11: Judgment of the Court (Third Chamber) of 22 November 2012 (reference for a preliminary ruling from the Bundesgerichtshof — Germany) — Brain Products GmbH v BioSemi VOF, Antonius Pieter Kuiper, Robert Jan Gerard Honsbeek, Alexander Coenraad Metting van Rijn (Reference for a preliminary ruling — Medical devices — Directive 93/42/EEC — Scope — Interpretation of the concept of ‘medical device’ — Product marketed for non-medical use — Investigation of a physiological process — Free movement of goods)

OJ C 26, 26.1.2013, p. 7–8 (BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

26.1.2013   

EN

Official Journal of the European Union

C 26/7


Judgment of the Court (Third Chamber) of 22 November 2012 (reference for a preliminary ruling from the Bundesgerichtshof — Germany) — Brain Products GmbH v BioSemi VOF, Antonius Pieter Kuiper, Robert Jan Gerard Honsbeek, Alexander Coenraad Metting van Rijn

(Case C-219/11) (1)

(Reference for a preliminary ruling - Medical devices - Directive 93/42/EEC - Scope - Interpretation of the concept of ‘medical device’ - Product marketed for non-medical use - Investigation of a physiological process - Free movement of goods)

2013/C 26/13

Language of the case: German

Referring court

Bundesgerichtshof

Parties to the main proceedings

Applicant: Brain Products GmbH

Defendants: BioSemi VOF, Antonius Pieter Kuiper, Robert Jan Gerard Honsbeek, Alexander Coenraad Metting van Rijn

Re:

Reference for a preliminary ruling — Bundesgerichtshof — Interpretation of the third indent of Article 1(2)(a) of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ 1993 L 169, p. 1), as amended by Directive 2007/47/EC of the European Parliament and the Council of 5 September 2007 (OJ 2007 L 247, p. 21) — Interpretation of the term ‘medical device’ — Application of the directive to an article which is intended for purposes of investigation of a physiological process and which is marketed for a non-medical purpose

Operative part of the judgment

The third indent of Article 1(2)(a) of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007, must be interpreted as meaning that the concept of ‘medical device’ covers an object conceived by its manufacturer to be used for human beings for the purpose of investigation of a physiological process only if it is intended for a medical purpose.


(1)  OJ C 232, 6.8.2011.


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