Borderline Product Ruling Cements Challenges for Devicemakers

“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 tells IMDRM.  Fortunately, the medical device regulations approved in a plenary session of Parliament last month include a central qualification mechanism that would be binding on all the member states, he noted (see related story). “That solves this problem to quite a large extent.”

In the meantime, devicemakers already have a mechanism to mitigate member state classification differences — a medical device expert group on borderline qualifications, housed under the European Commission. The group includes member state delegates who form a uniform opinion on devices submitted by EU countries. 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 may be sold in the same member state — one as a drug and the other as a device. The high court 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 country. The product at issue in the case is Gynocaps, a capsule for imbalances in vaginal bacteria.  It was originally marketed in Finland and other member states as a medical device, but the Finnish Medicines Agency later classified a similar product as a medicinal product. Lycocentre challenged the classification, and the agency moved to reclassify Gynocaps as a drug as well. 

REFERENCE: FDA News; International Medical Device Regulatory Monitor; November 2013; Vol. 21, No. 


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