Last week the EU Court decided Brain Products / BioSemi, one of the pending borderline cases involving demarcation between medical devices and ‘general stuff’. This case is interesting and important because it concerns a direct interpretation of the definition of medical device in the EU Medical Devices Directive (MDD), which is why I have already blogged about the Advocate General’s opinion in this case. It is also interesting because the case will not make the borderline between medical devices and general health / wellness products simpler. Apologies in advance for the less than concise and slightly rambling post, but I thought I would give you some insight in my thought process about the judgment.
Was was the case about again? Biosemi markets electrotechnical systems and equipment, in particular, a system called ‘ActiveTwo’. The system enables human brain activity to be recorded. Brain Products thought that this was a medical device. Since BioSemi did not have CE certification for such devices, the marketing of that product should be prohibited, argued Brain Products in German court. Why did Brain Products think that it was a medical device? Because the intended purpose of the device exactly fit the definition of ‘medical device’ in the MDD as a ‘device for the investigation of a physiological process’. BioSemi argued that the ActiveTwo device is not intended for medical use and can therefore not be classified as a ‘medical device’. Moreover, BioSemi argued, the fact that that system can be transformed into a diagnostic device does not lead to it being classified as a medical device. Finally BioSemi argued that a restriction on the marketing of ActiveTwo would be contrary to the principle of the free movement of goods since the competent Netherlands health authority takes the view that there is no need to certify that system.
The EU court’s conclusion is the same as the AG’s: the concept of ‘medical device’ covers an object conceived by its manufacturer to be used for human beings for the purpose of investigation of a physiological process only if it is intended for a medical purpose. The Court’s reasoning however is interesting and of course, it’s the final word on the matter; moreover the EU Court approaches the problem differently than the AG and only from two directions: teleological interpretation of the directive and the requirements of free movement of goods in the EU internal market.
Teleological interpretation: medical intended purpose
On this point the EU Court does one of its best interpretative tricks when it seeks to reconcile its intended conclusion with the lack of an explicit requirement of medical intent in the actual text of the law by holding that “ [i]t may be considered that the silence by the European Union legislature on that point is explained by the fact that medical use is inherent in the devices concerned.” (point 23) Fortunately, “that analysis is supported by Commission guidelines (Meddev 2.1/1) published in April 1994, which seek a uniform application of the provisions of Directive 93/42 within the European Union. That document contains Section I, entitled ‘Field of Applications – Definitions’ containing Chapter I, entitled ‘Directive 93/42/EEC on medical devices. Point I.1.1(b) in that chapter expressly states that medical devices are intended to be used for a medical purpose.” (point 24)
OK, but we knew this latter point already since 1994, nothing new except that the EU Court now says that the Commission was right on this point.
The free movement argument basically says that it would not help the internal market of goods if you regulate products that are not medical devices as medical devices. I follow that logic:
29 It follows that Directive 93/42 may have the effect of limiting the free movement of medical devices, by providing for an obligation for certification and CE marking in respect of those products only where such a limitation is necessary for the protection of public health.
But then the water gets muddier:
30 Therefore, in situations in which a product is not conceived by its manufacturer to be used for medical purposes, its certification as a medical device cannot be required.
“Conceived” is a tricky term here. Does that mean that the manufacturer’s conception is limited to ‘conceived initially’? That is what this word seems to mean; this is confirmed if you look at other language versions of the judgment. But what if the manufacturer decides to change the intended use later on because he sees possibilities in the medical market? In that case the device was not conceived as medical device, but may be intended to be used as such later. Would that still be covered by the MDD? I think yes, because that would be the only conclusion to avoid everyone phasing their devices in by changing the intended use to ‘medical’ at a later stage without consequences.
Where are we now?
The result is that we now seem to be stuck with an almost philosophical debate about the question what ‘medical’ means. In its reasoning the European Court refers to ‘protection of public health’, and everyone knows that ‘health’ is not the same as ‘medical’, because medical assumes something clinical, while health as a concept is much, much broader. This means that any device that promotes or sustains good health may be a medical device. That means that a large category of devices might be sucked into the scope of the MDD, like treadmills and body fat composition monitor apps on your smartphone. But wait, these things are actually not supposed to fall in the scope of ‘medical device’, as the EU Court excludes
in particular, […] many sports goods which enable the functioning of certain organs in the human body to be measured without any medical use. If such articles were to be classified as medical devices, they would be subject to a certification procedure without any justification for that requirement.
OK, so what, then, is “medical”? The scope of ‘medical’ seems to require a ‘medical context’, as may be gleaned from the EU Court’s example of software in points 16 and 17 of the judgment:
16 Next, it must be stated that the wording of Article 1(2)(a) of Directive 93/42 was amended by Article 2 of Directive 2007/47, recital 6 of which states that a software in its own right is a medical device when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device. That recital adds that software for general purposes when used in a healthcare setting is not a medical device.
17 As regards software, the legislature thus made unequivocally clear that in order for it to fall within the scope of Directive 93/42 it is not sufficient that it be used in a medical context, but that it is also necessary that the intended purpose, defined by the manufacturer, is specifically medical. [Underling and bolding are mine]
So we need two cumulative things for a device to be ‘medical’: a medical context and a medical purpose defined by the manufacturer.
But what is a “medical context”? That may well be a situation where a doctor uses a body fat composition monitor to measure my functioning and makes me run on a treadmill in a check-up visit. Conclusion: ‘medical context’ is not a helpful concept here, and only makes things more complex.
What about the medical purpose? The medical purpose must be “defined” by the manufacturer. Does this suggest that there is no room to objectify the purpose? It looks like it because that is what the case is about in the first place: a device has a ‘medical’ dual use, but the EU Court concludes that is not a medical device because the manufacturer says it isn’t. This primacy of the subjective intended purpose opens up a can of worms that may well lead to a lawyers’ paradise of attempts to de-medicalise things with obvious medical purpose, or at least, dual medical purpose. As a lawyer I like lawyers’ paradises of course, but I do not wish for them for the market. I also believe that this way of interpreting is inconsistent with scoping of the definitions other EU legislation regulating ‘medical stuff’, like medicinal products that use a definition that also looks both at the function of the product and the intended purpose. This has the obvious advantage that you can have a scientific discussion about the mode of action, while that is difficult when subjective medical intent is the only essential and deciding criterion to go by if we read the judgment literally. Finally, you put the door wide open for abuse of dual possibilities . Why buy an expensive ‘medical’ device if you can buy the same ‘non-medical’ device for half the price (because no investment in CE marking is required)? This again goes to the heart of the case at hand and is probably the very reason that Brain Products started the proceedings. And don’t forget, a level playing field is also what free movement provisions intend to achieve.
Another way to arrive at a better result
I wonder why the EU court took this difficult route of interpretation. Rather than pulling a rabbit out of its interpretation hat regarding the 3rd limb of the definition it could also have concentrated on the word “investigation” in the 3rd limb of the definition, because that was the actual question of the national court (“‘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?’”). It could have simply stated that the word “investigation” (which is not necessarily a medical term), should be interpreted as “investigation for medical purposes”. The interpretation chosen by the EU Court instead leads to some difficulties. Why? By pouring a ‘medical’ sauce over the whole definition you question the inherent medical content of other concepts as well, such as ‘therapeutic’. Are there non-medical therapeutic devices? In the mind of the EU Court there apparently are. Indeed, although the EU Court only ruled on the interpretation of the 3rd limb of the definition, its reasoning on ‘medical intended purpose’ and free movement is just as applicable to the rest of the definition.
Fortunately the amended definition in the Medical Devices Regulation proposal (MDR) avoids this problem, by making all limbs of the definition subject to the qualification ‘specific medical purpose’ but as a exhaustive list of medical purposes:
“‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific medical purposes of:
– diagnosis, prevention, monitoring, treatment or alleviation of disease,
– diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability,
– investigation, replacement or modification of the anatomy or of a physiological process or state,
[…]” [my underlining]
So the EU Court could also have referred to this new definition to determine what the Commission wants for medical devices in the EU market and arrive at this solution, and that would also have fit the MEDDEV it referred to. But it didn’t. That would have solved a lot of problems and now we have to wait for the MDR to enter into force, which may take at least a year or two.
Conclusion: the EU Court has not done the devices market a favour with this judgment, and certainly did not clarify the law if you ask me. It did create somewhat of a a lawyers’ paradise by potentially enlarging the scope of the MDD but at least muddying the borderline with general health and well-being device – I think – but please don’t shoot the messenger.
Very interesting analysis of this decision by the Court, my compliments!
I am wondering, is this really so complex? Compared to lawyers I may have a different way of looking at these questions. In my opinion it is quite easy: the manufacturer states that the device is intended to be used in a specific way. This may be in line with the definition of a medical device or not. For example, a device may be intended for ‘… diagnosis… of disease’ or ‘… monitoring… of an injury…’ In my view these are the ‘medical purposes’ that are meant by the definition. Therefore, there should be no problem as a result of this definition.
But maybe I overlook something. Please, correct me if I am wrong.
Hi Ron, thanks for your comment. Unfortunately things are that complex. I have many clients that struggle with this continuously. If you look at the many guidance documents on borderlines between the different regulated products such as medicines, ATMPs, food, cosmetics, biocides, general electronic devices and medical devices you can see it is really not that evident. On top of that comes the complexity of 27 (next year 28) competent national authorities and court systems that each can make their own (and not necessarily the same) appreciation of the facts and disagree with it. Add on top that there is no functional EU system for arbitrage in these matters and it’s no picknick if your product is something different everywhere. So, you would think it’s not that complex but it really is in practice.
This is one great and informative post! Thanks for sharing your remarkable thoughts on medical devices!
Thanks for the great post. In the US the definition of a medical device may be read slightly wider in that things that affect body structures are medical devices if so intended. We have a long history of identicla devices being medical or not, solely based upon intent shown in the labeling. For example, the treadmill cited in your post would be sports equipment if marketed that way, but medical if sold to doctors to be used as part of a stress test.
FDA regulations call this an “objective” showing of the intent of the seller, but as you say there is a certain subjective factor in it.
The key in the US is that both the drug and device definitions are completely based upon intent. I tell my students that the word “intended” in the definition is the most important word in the statute.
As a US representative for , and the former US representative for , I find this ruling hilarious in that BrainProducts relied in 2002 upon the same logic about intended use when importing their non-FDA approved, but presumably “medical”, devices to the US. I am not a lawyer, but I find intriguing the different approaches and underlying philosophies of the US and Europe with regard to whom should be responsible once a device is brought to market. As a former US exporter of MDD compliant medical devices, I have noticed that both approaches on the surface seem to place the reponsibility for compliance of a device on on the marketer (the manufacturer or the distributor). However, in the US, marketers are increasingly being held responsible for the misuse / misapplication of a device. IMHO, the determination of whether a product can be marketed legally should be made once and physicians should be empowered to use devices for purposes other than their intended use, yet they should also be liable when a drug or device is misapplied. Not so complicated, in my view.