The Court of Justice of the European Union (“CJEU”) has recently ruled on the interpretation of Medical Devices Directive (93/42/EEC) and Medicinal Products Directive (2001/83/EC). In the Case C-109/12 the Finnish Supreme Administrative Court had requested for a preliminary ruling on whether a product that had been classified as a medical device in one Member State could be classified as a medicinal product in another Member State.
The product in question, Gynocaps, was a vaginal capsule that had in several Member States been classified as a medical device bearing a CE marking. After being sold as a medical device also in Finland until 2008, the classification was changed to medicinal product by the Finnish Medicines Agency (Fimea), on its own initiative.
The CJEU ruled that despite the product being already classified as a medical device in several other Member States, there was no obstacle to recognize it as a medicinal product in Finland. However the CJEU stated that the process should adhere to the procedural requirements set forth in Medical Devices Directive. Furthermore, the CJEU held that a product that has the same substance and same mode of action as another product that is classified as a medicinal product, may be classified as a medical device within the same Member State, if so required by another characteristic that is specific to that product and relevant for the Medical Devices Directive.