EU Borderline Product Decision Cements Challenges for Devicemakers

A recent decision by the EU Court of Justice on borderline products confirms an ongoing practice by member states that can create challenges for devicemakers, says Erik Vollebregt of Axon Lawyers in the Netherlands.

The judgment in case C-109/12 found that different member states may classify the same product differently, whether as a medicinal product requiring clinical data or as a medical device.

“I don’t expect manufacturers to experience practical differences, except member states may now have a justification for a pretty wildly divergent interpretation of science,” Vollebregt said.

Fortunately, the new medical device regulations in the pipeline include a central qualification mechanism that would be binding on all the member states, he noted. “That solves this problem to quite a large extent.”

In the meantime, devicemakers already have a mechanism to mitigate member state classification differences. Vollebregt pointed to a medical device expert group on borderline qualifications, housed under the EC. The group includes member state delegates that form a uniform opinion on devices submitted by member states.

The only problem with this mechanism is that it is “very informal,” Vollebregt says. “It is not transparent to outside companies.”

Vollebregt, notes for instance, that there is no appeal mechanism. “Basically it’s just member states together reaching an informal consensus on how they will treat a medical device … and the quality of decisions coming out of that process is sometimes very poor.”

In the Laboratoires Lyocentre case, the EU Court of Justice was also asked whether two different products with the same substance and function can be sold in the same member state — one as a drug and the other as a device. It left that issue to member state courts, noting that similar products with the same substance and function could potentially be marketed differently within the same member state.

The product at issue in the case is a capsule for imbalances in vaginal bacteria. Gynocaps was originally marketed in Finland and in other member states as a medical device, but the Finnish Medicines Agency later classified a similar product as a medicinal product. That classification was challenged by Lycocentre. The agency also moved to reclassify Gynocaps as a drug product.

There’s no need to misclassify a product or confuse regulations across countries. Attend the Medical Device Quality & Compliance Institute 2013 Quality Systems and Design Control Training in order to find out how to best design your devices to meet the toughest requirements.