Interpretation of the definition of a medical device

The recent judgment of the Court of Justice of the European Union (hereinafter referred to as the EU TS) of 22 November 2012 in Case C-219/11 is important for the interpretation of the definition of 'medical device'. As a preliminary note, it is worth recalling that, in accordance with Council Directive 93/42/EEC of 14 June 1993, the Commission may, in accordance with the procedure laid down in Article 18 of Directive 93/42/EEC, adopt implementing provisions in accordance with the procedure laid down in Article 18 of That Directive. concerning medical devices, "medical device" means any tool, instrument, device, software, material or other article, whether used alone or in combination, together with any equipment, including software intended by its manufacturer for use specifically for diagnostic or therapeutic purposes and necessary for its proper use, intended by the manufacturer for human use for the purpose of:

– diagnosing, preventing, monitoring, treating or alleviating diseases,

– diagnosis, monitoring, treatment, alleviation or rehabilitation in the event of injury or impairment,

– examination, replacement or change of anatomical structure or physiological processes,

– regulation 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 functions by such means.

The legal proceedings which gave a direct impetus to the opening of proceedings for a preliminary ruling before the EU TS concerned the sale of electrical systems and equipment, in particular a system enabling the work of the human brain to be registered under the name 'ActiveTwo' ('ActiveTwo'). One party to the proceedings indicated that ActiveTwo was a medical device which did not have a CE marking for such devices and that its sale should therefore be prohibited. On the other hand, its sales entities took the view that, since ActiveTwo is not intended for medical purposes, it cannot be regarded as a 'medical device' within the meaning of Directive 93/42. Moreover, the fact that this system may be used as a diagnostic device cannot lead to it being classified as a medical device. Accordingly, restricting the sale of ActiveTwo would be contrary to the principle of the free movement of goods, especially since the competent Netherlands health authority considers that it is not necessary to certify that scheme.

In the light of the facts presented, the German court decided to ask the EU TS a preliminary ruling to determine whether an article intended by a manufacturer for human use for the purpose of testing a physiological process constitutes a medical device only if it is intended for medical purposes.

In support of its judgment, the Court referred, inter alia, to recital 18 in the form of Directive 93/42, from which it is apparent that it was in view of the specific objectives of the fight against AIDS that the EU legislature decided to extend contraceptive measures to the scope of that directive in order to ensure effective quality control; thus indicating the reason why this Directive should apply in the specific case of products used in humans to regulate conception. On the other hand, it is significant that the EU legislature did not provide such a justification for devices used for the purpose of physiological examination, which makes it possible to assume that the silence of the EU legislature on that point is due to the fact that the intended use for medical purposes is inextricably linked to the devices in question.

Furthermore, the EU TS pointed out that Directive 93/42 may lead to a restriction on the free movement of medical devices, providing for them to be required to certify and label CE only if such a restriction is necessary to protect public health. Moreover, if the product is not created by the manufacturer for medical use, then its certification as a medical device may not be required. In order to illustrate such a situation, the judgment referred to the case of numerous sporting articles which allow measurements to be made of the functioning of certain organs of the human body, with the exception of medical use. If such articles were to be considered as medical devices they would undergo a certification procedure, while it is not in any way justified.

Thus, in answer to the question referred for a preliminary ruling, the Court therefore held that, in view of the context of Article 81 EC, it was not possible to draw up a question on the part of the Court of Justice of the European Union. Whereas article 1 (2) of Regulation (EEC) No 2(a) directive 93/42 and the objectives of that directive, the concept of a device intended by a manufacturer to be used in humans for the purpose of testing a physiological process must be interpreted as meaning that the concept of 'medical device' includes an object created by the manufacturer for human use for the purpose of testing a physiological process only if it is intended for medical purposes.

KONDRAT Law Firm and Partners

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