A top advisor to the Court of Justice of the European Union (CJEU) has delivered an opinion to the Court in which he states that the scope of the Medical Devices Directive should be restricted solely to devices which are intended to be used for medical purposes. In order to avoid abuse, however, a product which, by its very nature, is intended to be used solely for medical purposes, but which is not described as a medical device by its manufacturer, will be regarded as such the purposes of the Directive.
The Advocate General’s opinion was delivered in a case referred to the CJEU by the German Supreme Court. The case concerns a device designed for recording electrical signals from the human body for research purposes The manufacturer claims that as the device was not designed for the medical sector and was not intended for medical diagnosis and/or treatment, it is not a medical device and need not be affixed with the CE mark required for medical devices under EU law. The plaintiff, a rival manufacturer, claims that, regardless of its intended use, since the recording of electronic signals from the human body is a measurement frequently taken in a medical context, the device must be regarded as a medical device and must be certified as such.
The Advocate General stated that a product which, by its very nature, is intended to be used solely for medical purposes must be regarded as a medical device, even if the manufacturer does not describe it as such. However, he added that a manufacturer’s intention as regards the use of a given product is not completely immaterial and that categorisation under the Medical Devices Directive cannot be based on objective factors only.
He considered that the scope of the Directive should be restricted to devices which are intended to be used for a medical purpose. Were the Directive to be construed otherwise, it would not be possible to market products designed for research purposes. The Advocate General noted that a precondition for the certification of medical devices is that “any risks which may be associated with their use constitute acceptable risks when weighed against the benefits of the patient.” This precondition gives rise to two difficulties in the case of products designed for research: (i) a healthy individual who voluntarily takes part in scientific tests cannot be described as a ‘patient’; and (ii) the risk/benefit profile of a product intended to be used purely for research purposes is, by definition, negative as such a product does not produce any individual benefit for the persons on whom it is used. Consequently, applying the rules set out in the Directive, certification of a product designed for research would always be refused.
Further, the Advocate General noted that the device in question was a modular product, comprising a set of different components which a purchaser can buy and configure to suit the type of investigation being carried out. The “intrinsically flexible nature” of the product makes it impossible to subject it to certification as a medical device as certification requires a “standardised” product the characteristics of which are capable of being assessed.
It remains to be seen if the CJEU will follow the Advocate General’s opinion.
Contributed by John Magee.