One product, two qualifications: medical device and medicine?

It is not being made any easier. In our previous NEWS, I discussed foodstuffs that can be qualified as medicines. Now there is an additional problem that medical devices can also be called medicines.  Medical devices include contact lens solution, blood glucose meters and plasters for example but also artificial kidneys.

The highest court in Finland has put preliminary questions to the European Court. The most important question: may a product be qualified as a medicine whereas the same product is considered to be a medical device in another member state? According to the Advocate General (AG) at the Court that is indeed possible.

The Medical Devices Directive does not rule out that the medical device may also be a medicine in the meaning of the Medicines Directive, says the AG. This means in practice that a product which is sold in Germany on the market for example might be a medical device in the Netherlands under the stricter Medicines Legislation or vice versa. In brief: a different regime in different member states for the same products.

What if the Court follows this advice from its Advocate General, what will that mean? Firstly, that it will differ per country which claims are allowed for your product. Secondly: the risk that a medical device may be more readily labelled as a medicine. The latter would be a most undesirable development. After all, if a product is considered to be a medicine less is allowed in advertising for that product. The medicines regime is a lot stricter than the rules on medical devices.

The Advocate General’s opinion has been given. Now we can only hope, but unfortunately not expect, that the European Court will decide differently. To be continued…

Christine Fontaine, health beauty & food law lawyer

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