Dec 15, 2010

The European Court has recently ruled to limit member states’ authority to restrict medical device sales to specialty shops, supporting device manufacturers’ ability to sell their wares online throughout the European Union.

More significantly, the Court’s ruling may come to be seen as establishing primacy of EU law over member states’ regulations—at least when it comes to e-commerce issues affecting low-risk medical devices. Whether the Court assumes a similar position for higher-risk products remains to be seen.

The Court’s action stems from recent Hungarian legislation restricting the sale of contact lenses only by shops specializing in medical devices, a move which effectively would ban Internet sales of such products in the country. Following the legislation’s passage, the Hungarian health ministry ordered online contact lens seller Ker-Optika to cease transacting over the Internet. The merchant subsequently challenged the ministry’s order, prompting a district court to seek guidance from the European Court on whether EU mandates trump national law in this instance.

Hungary’s ban on online selling of contact lenses impedes the free movement of goods through the EU, the Court ruled, because the law affects not only Hungarian merchants but any European firm selling similar products online to Hungarian customers. Although Hungarian legislators’ aim in requiring sale of medical devices only by qualified staff (in this case opticians’ shops) was ostensibly to protect consumer health—a move the Court deemed appropriate on a broad level—the new legislation does not take into account similar services available to consumers from ophthalmologists, or that consumers typically do not require consultation from qualified staff for refilling contact lens orders unless prescription changes are necessary.

Member states’ national rules regarding whether vendors may sell devices online must accord with the e-commerce directive, ruled the Court, but national regulations governing how devices are supplied to end users do not fall under the directive’s purview. Rather, such rules should instead align with the EU’s general internal market rules on free movement of goods.

Ruling that Hungarian authorities can uphold consumer safety through “less restrictive” measures, the Court has emphasized the need for EU member state measures to protect public health more in proportion to the nature of the medical devices in question, and in accordance with EU commerce directives.

Bottom line: For medical device manufacturers selling low-risk products online in Europe, EU laws pertaining to unimpeded e-commerce across the trading bloc trump national regulations.


  • Stewart Eisenhart