European Court Clarifies Restrictions On Sale Of Medical Devices With Respect To E-Commerce And Specialty Shops

EU member states are not under all circumstances allowed to restrict the sale of medical devices to only brick-and-mortar shops that specialise in medical devices.

That is the outcome of the recent Ker-Optica judgment (C-108/09 of 2 December 2010), concerning a dispute about the legality of Hungarian legislation which authorises the sale of contact lenses only in shops that specialise in the sale of medical devices and, consequently, prohibits the sale of contact lenses via the Internet.

The European Court ruled on two points of law important to members of the medical devices industry seeking to sell medical devices to consumers in the EU online.

First, it clarified the scope of the e-commerce directive with respect to the national rules prohibiting Internet sales of contact lenses. It held that national rules relating to whether or not medical devices can be sold via the Internet fall within the scope of the e-commerce directive because medical devices are not excluded from its scope. However, national rules that seek to regulate how medical devices are supplied to the end user (e.g., only after a prior examination for fitting) fall outside the scope of the e-commerce directive and, consequently, cannot be assessed by the rules that the e-commerce directive imposes. Those national rules have to be assessed under the general EU internal market rules on free movement of goods. Given that the sale of medical devices via the Internet falls within the scope of the e-commerce directive, the European Court ruled that Internet sales as such cannot be prohibited, even in cases where a prior examination by qualified staff would be necessary, because that examination can be separated from the subsequent Internet sale.

Second, what then are the restrictions that general EU free movement of goods rules impose on national requirements to sell certain medical devices only from shops with qualified personnel? First of all, these rules hinder access to the market of the member state that has those rules more for foreign traders than for local traders, the court reasoned, with reference to the DocMorris case (C-322/01 of 11 December 2003, [2003] ECR I-14887) concerning Internet sales of medicinal products. That restriction must therefore be justified. However, the European Court finds that the type of devices in question does not justify this type of restriction for three reasons (paraphrased wording from the judgment):

In regards to the requirement that...

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