On 22 November 2012, the Court of Justice of the European Union rendered a judgment interpreting what constitutes a medical device in the European Union (“EU”).
The Court was asked to respond to the question whether a device intended to investigate a physiological process constitutes a medical device governed by the Medical Devices Directive if, in the specific situation, the device is not intended by its manufacturer to be used for a medical purpose.
The device in question is the ActiveTwo system, which permits the recording of the activity of the human brain. The device is not intended by its manufacturer, Biosemi, to be used for a medical purpose and is not marketed as a medical device in the EU. The Biosemi website describes the ActiveTwo system as a multi-channel, high resolution biopotential measurement system for research applications. The ActiveTwo system is intended by Biosemi to be used for the conduct of non-medical research in areas such as the cognitive sciences. According to the site, this could include non-medical research in the fields of linguistics, education and artificial intelligence. The Biosemi website also states that ActiveTwo is not designed or intended to be used for diagnosis or treatment of disease. However, Biosemi’s competitors considered that the ActiveTwo system constitutes a medical device and that it should be CE marked in accordance with the requirements of the Medical Devices Directive.
The Court concluded, however, that a device designed for the investigation of a physiological process in the human body should be considered a medical device only if the device is intended by its manufacturer to be used for a medical purpose. Although the Medical Devices Directive does not contain an explicit reference to the need for medical devices to have a medical purpose, the Court ruled that the medical purpose must be regarded as an inherent part of the concept of a medical device provided for in the Directive.
The Court also ruled that to interpret the Medical Devices Directive as imposing an obligation on a manufacturer to CE mark a product as a medical device even though it was not conceived by its manufacturer as having a medical purpose would be an unjustified obstacle to the free movement of goods in the EU. According to the Court, the aim of the Medical Devices Directive is to require the CE marking of medical devices and compliance with related regulatory obligations only where such restrictions are necessary for the protection of public health. The protection of public health would not justify a limitation on the free movement of devices that are not intended by their manufacturers to have a medical use.
In principle, the ruling of the Court means that the intended purpose of the device, as defined by the manufacturer, would be decisive in determining whether the device is a medical device governed by the Medical Devices Directive. Manufacturers would not be required to comply with the Medical Devices Directive if they did not intend their products to be used for a medical purpose.
The Court’s interpretation of the Medical Devices Directive reflects the European Commission’s interpretation found in the MEDDEV Guidelines. The Guidelines provide that medical devices are products intended to be used for a medical purpose. However, like the MEDDEV, the Court did not clarify what should be considered to constitute a medical purpose.
Moreover, the Court did not address either the circumstances in which a product has potentially both a medical and non-medical purpose, or the circumstances in which a device, although presented by its manufacturer as non-medical, is commonly considered to be a medical device due to its intended purpose. Experience suggests that competent authorities and notified bodies in the EU will often adopt a more conservative position taking account of the broader context in which the product is presented rather than limiting their conclusions as the most appropriate classification of a device to the view of its manufacturer.