European court rules on borderline products

The Court of Justice of the European Union (CJEU) has given judgment in case C-109/12, which concerns some practical effects of the borderline between medicinal products and medical devices and arises from a reference from the Finnish Courts.

The case concerns a capsule used for correcting bacterial imbalances in the vagina. The product was marketed in Finland and continues to be marketed in other member states as a medical device with a CE mark. The Finnish National Agency for Medicines decided in 2008 that the capsule should no longer be considered to be a medical device but was instead a medicinal product that required a marketing authorisation. At the time, a similar product had recently been classified in Finland as a medicinal product. The manufacturer challenged this decision in the Finnish courts and the Finnish Supreme Administrative Court referred three questions to the CJEU for a preliminary ruling.

The significance of whether a product should be considered to be a medical device or a medicinal product is apparent in the approval process that must be gone through before marketing. A medicinal product may not be marketed without a marketing authorisation, which requires clinical data supporting the safety and efficacy of the product. Less onerous obligations currently apply to medical devices. Furthermore, there are provisions of the legislation governing medical devices that provide that a product that has been CE marked when it is not actually a medical device may have to be removed from circulation…

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