A loophole in the law covering the sale of medical devices, which left manufacturers facing huge financial and regulatory burdens, has been closed following a European Court of Justice ruling.
This week the court ruled that only products intended by their manufacturer to have a clear medical use would be covered by the Medical Devices Directive (MDD), which lays out exactly which devices can be marketed within the healthcare sector. To win this certification they must undergo tough tests and trials, which take time and have a significant financial cost attached to them.
The ruling states: “Clearly, there are many factors to suggest that an exclusively literal interpretation of the definition of ‘medical device’ given in Directive 93/42 is not satisfactory. On the contrary, it seems more appropriate to restrict the scope of the directive and, more specifically, the scope of the third indent of Article 1(2)(a) solely to devices which are intended to be used for a medical purpose.”
Clearly, there are many factors to suggest that an exclusively literal interpretation of the definition of ‘medical device’ is not satisfactory. On the contrary, it seems more appropriate to restrict the scope of the directive solely to devices which are intended to be used for a medical purpose
It describes a medical device as ‘a product which is intended by the manufacturer to be applied for human beings for the purpose of investigation of a physiological process’.
The move will help to clear up the ongoing confusion that has seen simple devices such as toothbrushes and false nails classed as medical devices and as such subjected to the increased checks.
The court was asked to consider the issue as part of a case brought by BioSemi, a company governed by Netherlands law, which markets a product called ActiveTwo. 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 are researchers carrying out investigations, particularly in the cognitive sciences.
Because of this intended use, the product does not bear the CE marking attesting to conformity with the MDD. That fact is currently made clear on the manufacturer’s website. The website also states that ActiveTwo is a product that is not designed for medical uses.
However, Brain Products, one of BioSemi’s competitors, recently brought an action against BioSemi on the basis that, regardless of its intended use, the system must be regarded as a medical device for the purposes of the directive and, accordingly, must be certified as such.
The action brought by Brain Products was dismissed at first and second instance and is now pending before the Bundesgerichtshof, but it has voiced doubts on the matter and referred it to the European Court of Justice for a preliminary ruling.
In summary, the ruling states: “An element of clarification is needed here. 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 the consistent practice of medical structures is to purchase only products which have been certified in accordance with the directive.
Manufacturers of products not intended for use as medical devices can now take some measure of comfort from this decision, as it adds clarity to an uncertain area and removes the additional financial and regulatory burdens of complying with the MDD for products that are not intended to be used for medical purposes
“Furthermore, the fact that a product has not been categorised as a medical device should not be taken to imply that it may present a particular risk for users. All of the other general provisions to guarantee product safety continue to apply, including those which, for example, require conformity and the affixing of the CE marking to all electrical equipment, to all equipment which could cause problems relating to electromagnetic compatibility and so on.”
And it states that the ruling will not affect patient safety as manufacturers will still have to meet stringent guidelines, adding: “Paradoxically, in many cases, other forms of certification lay down requirements which are even more stringent than those imposed in relation to medical devices. While a medical device may, generally, entail risks, including significant risks, provided that those risks are offset by adequate benefits, the other forms of certification do not, in the majority of cases, permit a similar balance to be struck and tend simply to require that any possible risk be minimised.
The decision is an important one for manufacturers of products that are not intended to be used for medical purposes, but which have an ancillary or even diagnostic function.
Commenting on the outcome of the case, legal expert Maria Isabel Manley of Bristows Regulatory Practice, told BBH : “The ruling is a seemingly sensible one and reinforces that it is the manufacturer’s intention and the information which the manufacturer provides with the product that will determine whether the device is intended as a medical device and consequently falls within the scope of the MDD.
“Manufacturers of products not intended for use as medical devices can now take some measure of comfort from this decision, as it adds clarity to an uncertain area and removes the additional financial and regulatory burdens of complying with the MDD for products that are not intended to be used for medical purposes.
”Taking a more literal interpretation of the MDD would result in many everyday items such as toothbrushes or false nails being considered as medical devices which is undoubtedly not the intention of the MDD. However, manufacturers must take note as it remains to be seen how the courts will apply this decision to a product clearly intended to be used solely for a medical purpose, when the manufacturer does not describe it as such.”
Click here to read the full ruling.