In a judgment published on November 22, 2012, the Court of Justice of the European Union (CJEU) confirmed that products intended for the investigation of physiological processes only fall within the scope of the EU Medical Device Directive (93/42/EEC), as implemented into EU Member State legislation, if the products are intended for a medical purpose.
The case concerned a product intended for the investigation of a human physiological process, but not intended by the manufacturer for a medical purpose. A competitor sued the manufacturer and alleged that, regardless of its intended use, the product falls within the definition of a medical device and is subject to the related requirements.
The CJEU’s judgment is consistent with, and partly relies on, the guidelines published by the European Commission in 1994 (MEDDEV 2.1/1, available here), which indicate that medical devices are “articles which are intended to be used for a medical purpose [...] assigned to a product by the manufacturer” (original emphasis). Stakeholders should note that it continues to be, primarily, the manufacturer’s intended use - as reflected on the label, the related promotional material, and in the instructions for use - that determines the classification of a product as a medical device.
The European Commission has attempted to address remaining ambiguity with respect to the required ‘medical purpose’ of medical devices in its legislative proposal for an EU Medical Devices Regulation, intended to replace the current EU Medical Device Directive (see our related Update, available here), by explicitly requiring such a purpose in the definition of a ‘medical device’.
The proposed EU Medical Devices Regulation will, however, not become applicable until three years after its adoption and entry into force. Stakeholders should, therefore, consider the implications of this judgment (available here), and monitor the outcome of two further cases regarding the classification of borderline products on which the CJEU is expected to rule in the coming months.