Borderline cases in medical devices are considered to be those where it is not clear from the outset whether a given product is or is not a medical device. The European Commission released recently an update of the manual on borderline cases. Despite the fact that this is not legally binding, there is a high risk of similar product being challenged once they have been classified as non-medical device in the manual. However, only the European Court of Justice (ECJ) can provide an authoritative interpretation of Community law.

An example of these borderline cases is D-mannose. D-mannose was introduced in the EU market in 2015 as a medical device Class IIa for the prevention of urinary tract infections (UTIs). However, based on the scientific data available, the interaction between D-mannose and FimH (a cellular constituent of the fimbria of Escherichia coli present within the user’s body) is due to a pharmacological mode of action and not by a mechanical or physical action. Escherichia coli is the main cause of UTIs. Thus, medical devices containing D-mannose do not meet the definition of a medical device and should, therefore, not be marketed in this category.

Another interesting example included in this manual is mineral salt (zeolite), which is used in suspension formulation of medical device products intended to reduce the effect of alcohol. This product is to be taken before the consumption of alcohol with the purpose of reducing the blood ethanol content. According to the manufacturer, the product is a medical device because it prevents and reduces the risk of developing diseases such as hepatic cirrhosis, arterial hypertension, or ischemic/ haemorrhagic ictus by physically binding ethanol. However, reducing the absorption of ethylic alcohol in the blood is not considered a medical purpose. Thus, this product does not fit the definition of medical device, according to Article 1.2 of Directive 93/42/EEC, and thus should not be marketed as such.

Do you need a gap analysis to align with the New Medical Device Regulation (MDR) for your product? a&r has experience to assist medical device companies to update their Technical Documentation.

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– 26.04.2018

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