The Court of Justice of the European Union (CJEU) has recently ruled that products which fall within the definition of a medical device, but are not intended by their manufacturer to be used for a “medical purpose,” do not fall within the scope of the Medical Devices Directive 93/42/EEC (MDD).
Case C-219/11 Brain Products GmbH V BioSemi VOF and Others, concerned the product ActiveTwo, a “biopotential measurement system” that records electrical signals from the brain, heart and muscles, manufactured and is marketed by Dutch company BioSemi. ActiveTwo is not designed for use in any medical diagnosis or treatment, but is used by researchers for clinical investigation of cognitive sciences. BioSemi’s website and promotional material state that the product is “not designed or intended to be used for diagnosis or treatment of disease.” As such, BioSemi argued that the ActiveTwo was not a medical device and so did not require CE-marking.
Brain Products markets a similar device for clinical purposes that produces electrocardiograms (ECGs), electroencephalograms (EEGs) and electromyograms (EMGs). Brain Products’ device had been CE-marked in accordance with the MDD. Brain Products argued that ActiveTwo should have been CE-marked as a medical device because, irrespective or marketing, ActiveTwo was capable of being used in a medical diagnostic context, and must be certified accordingly.
The German Federal Court (Bundesgerichtshof) referred the following question to the CJEU:
“Does a product which is intended by the manufacturer to be applied for human beings for the purpose of investigation of a physiological process constitute a medical device, within the terms of the third indent of Article 1(2)(a) of [the MDD], only in the case where it is intended for a medical purpose?”
Article 1(2)(a) defines a medical device as:
“[…] any […] article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: […] investigation, replacement or modification of the anatomy or of a physiological process […]”
Advocate General Mengozzi favoured a “teleological and systematic” interpretation of Article 1(2)(a) so that the Directive covers only products intended to have a medical use. The CJEU applied this approach, agreeing that “[where] a product is not conceived by its manufacturer to be used for medical purposes, its certification as a medical device cannot be required” as it will not fall within the ambit of the MDD.
The CJEU noted that the title Medical Device Directive (emphasis added) would appear inconsistent if products not intended for medical use fell within the legislation. The European Commission’s guidance document Meddev 2.1/1 confirms that “medical devices are defined as articles which are intended to be used for a medical purpose.” Further, the MDD consistently refers to patients, whereas the intended test subjects for ActiveTwo were healthy volunteers in cognitive science research.
In addition, the CJEU noted that Article 1(2)(a) of the MDD is amended by Article 2 of Directive 2007/47/EC, Recital 6 of which states that:
“…software…specifically intended by the manufacturer to be used for… the medical purposes set out in the definition of a medical device, is a medical device. Software for general purposes when used in a healthcare setting is not a medical device.”
The CJEU said that in interpreting the MDD, it had to consider the context and the objectives of the relevant provisions, as well as the wording; that the MDD was only intended to apply to products with a medical use; and that it was intended to harmonise and remove disparities in regulation of medical devices between Member States and thereby promote free movement of goods.
The CJEU’s reasoning suggests that only the manufacturer’s intention is relevant. However, it is unclear how the this decision deals with situations where a manufacturer of a product not labelled or marketed as a medical device sells the product to a clinic or hospital for a medical purpose, notwithstanding product labelling. The Advocate General suggested that, although the manufacturer’s description and information will be key in determining the intended use of a product, any product which, by its very nature, is clearly intended to be used solely for a medical purpose will be considered a medical device, even if the manufacturer does not describe it as such. However, the CJEU did not elaborate on this point.