In the case Brain Products GmbH v BioSemi VOF (Case C-219/11) the Court of Justice for the European Union ("CJEU") has clarified the meaning of 'medical device'.
The European directive which governs medical devices (Council Directive 93/42/EEC (the "Directive") defines them as:
"any instrument, apparatus, appliance, software, material or other article, ... intended by the manufacturer to be used for human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means."
One of the requirements of the Directive is that, in order to be marketed in Europe, all medical devices must have CE certification and bear a CE mark.
The defendants in this case produced equipment which enables human brain activity to be recorded. The claimants argued that such equipment fell within part (c) of the above definition and hence should be classed as a medical device. In turn, as the defendants did not have CE certification for the equipment, the claimants argued that they should be prohibited for marketing the product.
The defendants counter-argued that as the equipment was not intended for medical use it could not be a medical device.
The CJEU held that part (c) of the definition 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. The equipment in question therefore did not require CE certification.
To find otherwise would mean that other goods (such as sports goods) which enable the functioning of certain organs in the human body to be measured without any medical use would fall within the definition and be subject to the CE certification procedure without any justification. The requirement for CE certification, and hence the potential limitation of free movement of goods, is justified by the necessity to protect public health.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
