On 3 October 2013, the Court of Justice of the European Union (CJEU) delivered its judgment in case C-109/12 concerning the legal status of medical devices. The CJEU confirmed Advocate General Sharpston’s opinion (see our previous post) that Member States may classify the same product differently and that if they reclassify a device as a medicinal product, the product must be immediately removed from the market and a marketing authorisation sought. The case highlights the lack of harmonization in the EU on the classification of borderline products and the risk that manufacturers of products currently classed as medical devices may face.
As discussed in our earlier post, the case arose from the Finnish Supreme Administrative Court who sought a preliminary ruling from the CJEU on three questions:
- Can a Member State classify a product as a medicinal product if another Member State has classified the same product as a medical device?
- What is the procedure for reclassifying a medical device as a medicinal product? Should the process set out in Directive 2001/83/EC (the Medicinal Products Directive) be followed, or should the competent authorities applies the provisions in Articles 8 and 18 of Directive 93/42/EEC (the Medical Devices Directive)?
- Can a product similar to a medicinal product (identical active substance and same mode of action) be classified as a medical device in the same Member State?
The CJEU concluded that Member States may classify the same product differently because there is not yet full harmonization in this area. The CJEU repeated the Advocate General’s reasoning that Member States may reach different conclusions due to new scientific developments, and the different assessment of risks and the desired level of protection.
The CJEU held a competent authority should follow procedures under firstly the Medical Devices Directive and secondly the Medicinal Products Directive to reclassify a medical device as a medicinal product. The manufacturer must remove the product from market immediately and apply for a marketing authorisation.
The CJEU and Advocate General came to slightly different conclusions on the third question. The Advocate General opined that the facts that two products contain the same substance and have the same modes of action are insufficient to conclude that they must be classified and put on the market in the same manner.
The CJEU emphasised that in borderline cases, where a product has one of the same substances and the same mode of action as the medicinal product, the former should in principle also be classified and marketed as a medicinal product. However, the CJEU stated that it was for the courts of the Member State in question to decide whether similar products in the same Member State may be classified as a medical device and a medicinal product respectively.