On 3 October 2013, the Court of Justice of the European Union issued a judgment in Case C-109/12, which concerned the implications of classification of a product as both a medical device and as a medicinal product within the same EU Member State and within the European Union (hereinafter “EU”) Internal Market. The case responds to a request for a preliminary ruling from the Finnish Supreme Administrative Court. In its judgement, the Court concluded that neither the Medical Devices Directive nor the Community Code exclude the possibility that a product can be classified as a medicinal product in one EU Member State and as a medical device in another.
Laboratories Lyocentre manufactures a vaginal capsule used for correcting bacterial imbalances, which consists of a particular bacterium of the lactobacillus genus. Since 2006, this product has been marketed and classified as a medical device under Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (hereafter “Medical Devices Directive”) in Finland under the name Gynocaps. The CE marked Gynocaps is also sold and marketed as a medical device in Spain, France, Italy and Austria.
On 14 October 2008, the Finnish National Agency for Medicines, decided that Gynocaps could no longer be marketed as a medical device within the meaning of the Finnish Law on medical devices and accessories; and should instead be marketed and classified as a medicinal product for which Laboratories Lyocentre is required to obtain a marketing authorisation in accordance with Directive 2001/83/EC on the Community code relating to medicinal products for human use (hereinafter “Community Code”).
Request for Preliminary Ruling
Laboratories Lyocentre appealed the decision of the National Agency for Medicines to the Finnish Supreme Administrative Court. On 27 February 2012, the Finnish Supreme Administrative Court requested a related preliminary ruling by the Court of Justice of the European Union (hereinafter “Court”).
Three questions were posed to the Court: i) can one EU Member State classify a product as a medicinal product while another EU Member State classifies the product as a medical device? ii) What is the process for reclassifying a medical device as a medicinal product? Is it sufficient to follow the procedures set out in the Community Code? Or is it necessary, prior to initiating procedures under the Community Code, for the competent authorities to follow the applicable provisions of the Medical Devices Directive, particularly Articles 8 and 18? iii) Can a product with the same active substance and mode of action be on the market in one EU Member State as both a medicinal product and a medical device?
Classification as a medicinal product and as a medical device
The Court concluded that neither the Medical Devices Directive nor the Community Code exclude the possibility that a product can be classified as a medicinal product in one EU Member State and as a medical device in another. The Court refers to the incomplete harmonisation of the EU Internal Market as a reason behind the divergent approaches by EU Member States concerning the classification of products. Citing paragraph 63 of Advocate General Sharpston’s Opinion on 30 May 2013, the Court stated that “asymmetries in (scientific) information, new (scientific) developments, and differing assessments of risks to human health and the desired level of protection” may explain why EU Competent Authorities reach opposing decisions concerning classifications.
Therefore, while a product may be classified as a medical device in one EU Member State and be CE marked according to the Essential Requirements laid down in Annex I of the Medical Devices Directive, other Competent Authorities of the EU Member State may classify the same product as a medicinal product provided the product satisfies the definition of a medicinal product under Article 1(2)(b) of the Community Code.
Process for classifying a medical device as a medicinal product
The Court added that, before concluding that a product marketed as a medical device in its territory should rather be authorised as a medicinal product in accordance with the Community Code, it should investigate whether the product has been unduly classified as a medical device. If this proves to be the case, the EU Member State may prevent the product being placed on its territory or require its withdrawal.
Where application of this national authority procedure, which is provided for in Articles 8 and 18 of the Medical Devices Directive, leads to the conclusion that a product was inappropriately classified as a medical device, the manufacturer must seek a marketing authorisation for the product as a medicinal product in accordance with the provisions of the Community Code in order to market the product in the EU.
Classification of similar products in the same EU Member State
The Court held that, in principle, two products which have the same active substance and have the same mode of action cannot be classified differently so as to allow one product to be marketed as a medicinal product and the other as a medical device. However, the Court did not preclude EU Member States from classifying two similar products differently, even in such circumstances. However, it would be for the national courts to verify, on a case-by-case basis, whether another characteristic that is specific to the product and relevant for the purposes of the definition of a medical device does not preclude the product from being classified as a medicinal product and marketed as such.