The Court of Justice of the European Union (CJEU) has recently handed down a decision in case C-109/12, a reference from the Finnish courts concerning the boundary between medical devices and medicinal products.
The French pharmaceutical company, Laboratoires Lyocentre, manufactures a vaginal capsule, called ‘Gynocaps’, containing live lactobacilli intended to restore the balance of bacterial flora in the vagina. Until 2008, Gynocaps was marketed in Finland as a medical device bearing a CE mark and is currently marketed this way in a number of other EU states including: Spain, France, Italy and Austria.
The Finnish National Agency for Medicines became aware that a vaginal preparation similar to Gynocaps was being marketed as a medicinal product rather than a medical device. On review of Gynocaps the Agency decided that the principal effect of the product was to correct or restore certain physiological functions through metabolic and pharmacological action. Therefore, the Agency decided that Gynocaps was not a medical device, but a medicinal product requiring a marketing authorisation.
Laboratoires Lyocentre appealed against this decision in the Finnish Courts and the Finnish Supreme Administrative Court referred the following questions to the CJEU for a preliminary ruling:
(1) Does a definition given in one Member State in accordance with Directive 93/42, by which a product is regarded as a medical device or accessory in accordance with that directive and is provided with a CE marking, preclude the competent national authority of another Member State from defining the product concerned, on the basis of its pharmacological, immunological or metabolic effects, as a medicinal product in accordance with Article 1(2)(b) of Directive 2001/83?
(2) If the answer to the previous question is in the negative, can that competent national authority define the product as a medicinal product observing only the procedures under Directive 2001/83 or is it necessary, prior to initiating procedures under that directive to define the product as a medicinal product, to follow the safeguard procedure in Article 8 of Directive 93/42 or to comply with the provisions of Article 18 concerning an unduly affixed CE marking?
(3) Does Directive 2001/83, Directive 93/42 or other European Union legislation (including legislation concerning the protection of human life and health and consumer protection) preclude products containing the same substance and having the same modes of action from being marketed in the same Member State both as medicinal products in accordance with Directive 2001/83, requiring a marketing authorisation, and as medical devices or accessories in accordance with Directive 93/42?
The CJEU decided that the answer to the first question is that the classification of a product in one member state as a medical device bearing a CE marking does not preclude the competent authorities of another member state from classifying the same product as a medicinal product.
With regard to the second question, Articles 8 and 18 of the Devices Directive 93/42 which provide for the withdrawal of medical devices from the market where the CE mark has been inappropriately applied must be applied before the product can be re-categorised as a medicinal product. The manufacturer then needs to apply for a marketing authorisation to be able to market the product.
For the final question, the CJEU concluded that it is possible that similar products could be differently classified, one as a medicinal product and the other as a medical device, in the same member state, although this would be a question for the competent national authorities to decide.
Thus, manufacturers should be aware of the possibility that their product may be classified as a medical device in some member states while in others it is considered a medicinal product and therefore must comply with the more onerous requirements for marketing authorisation. Moreover, there is also the possibility that an existing CE marked product will need to be removed from the market and will remain off sale, potentially for a considerable period, until a marketing authorisation is granted. Thus, companies manufacturing and selling medical devices may wish to review their portfolio to highlight any products at risk of re-classification.