The Advocate General of the EU Court presented his conclusion today in one of the three medical devices borderline cases currently pending at the EU Court, C-219/11 Brain Products vs BioSemi. The other two are C-109/12 Lycocentre and C-308/11 Chemische Fabrik Kreussler, with respect to the latter see also here. The other two are more interesting as far as I am concerned as they address the demarcation vis-a-vis directive 2001/83, the medicinal products directive, and an interesting question about the possibility for national authorities to qualify products differently for regulatory purposes in C-109/12 Lycocentre. So if you ask me, these are the two to watch for the moment.
But let’s look at Brain Products. This case concerned the question “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 Directive 93/42/EEC, only in the case where it is intended for a medical purpose?”. The question was raised in a court case about a device that the manufacturer did not intend for medical use:
“This is a system capable of recording electrical signals from the human body and, more specifically, from the brain (EEG), the heart (ECG) and the muscles (EMG). Although measurements of that nature are frequently taken in a healthcare context (using electrocardiograms, electroencephalograms and so on), the product in question is not designed for the medical sector and the related promotional material explicitly states that it is not designed to be used for diagnosis and/or treatment. The primary users of ActiveTwo, which is modular and can therefore be configured to meet the needs of individual customers, are researchers carrying out investigations, particularly in the cognitive sciences.”
Brain Products sued manufacturer BioSemi alleging that, regardless of its intended use, the system manufactured by BioSemi must be regarded as a medical device for the purposes of the directive and, accordingly, must be certified as such.
To summarise the long and winding argument of the AG: it’s the intended purpose of the manufacturer that determines if something is a medical device, not the purpose others may give to the device. The AG solves the problem by demonstrating teleologically why the scope of the medical devices directive is and was always determined by the overarching requirement of intent of medical use by the manufacturer (as the Commission set out in MEDDEV2.1/1 from 1994, the very first guidance document on the medical devices directive). To demonstrate this, the AG referes to ‘dual use’ products such as software and toothbrushes to show that the medical intended purpose determines the scope of the directive in relation to a product.
There is one Easter egg in the conclusion, in point 63, which concerns a question that is often asked in relation to obvious borderline products with a big disclaimer on them theat they are not intended for medical use even if they are clearly so intended, like many iPhone and iPad apps:
“Even if the information provided by the manufacturer is the key factor in determining whether a product is intended to be used for a medical purpose, any product which, by its very nature, is clearly intended to be used solely for a purpose of a medical nature will have to be regarded as a medical device, even if the manufacturer does not describe it as such. In any event, that proviso, which is designed to prevent abuse, ought not to be needed in most cases, since – including for obvious reasons of professional liability – the consistent practice of medical structures is to purchase only products which have been certified in accordance with the directive.”
This is something, as I have debated my theory with cheeky app developers who were not convinced about my answer that you cannot disclaim an obvious intended purpose as this would amount to a contradictory label and consequently an non-compliant product. The AG uses an even shorter punch: you cannot disclaim obvious intended purpose by nature. I am not sure if this is the best way to deal with this problem, as the “obviousness” of intended purpose may be difficult to establish especially in the case the manufacturer does not describe it on the label or other materials. Like Mr Jaggers in Dickens Great Expectations I prefer to rely on facts (“Take nothing on its looks; take everything on evidence. There’s no better rule.”). Imputing an “intended use by nature” that is not described is a challenge from an evidence perspective to say the least. Although I agree with his conclusion on the law I think AG Mengozzi is overshooting his target here.
I don’t expect the Court’s judgment to provide big surprises either. Just like we have seen and expect with other borderline cases, the Court will limit itself to formulating a legal criterion that may not always be very helpful in the light of the facts of the case because the Court is not allowed to do the work of the national court. But we’ll know in a couple of months when the Court hands down its judgment.