Germany - Parallel Import of Medical Devices Christian Hertz-Eichenrode, FPS By a decision of 30 April 2015, the German Federal Supreme Court referred a case to the European Court of Justice in order to get more guidance on the interpretation of European directive 98/79/EC relating to in-vitro diagnostic medical devices (diabetes test strips). Roche Diagnostics GmbH is a manufacturer of different blood glucose metre systems. For their Accu-Chek Aviva and Accu-Chek Compact devices Roche distributes separate test strips in order to ensure the accuracy of the blood tests. The defendant is a reseller and importer of medical devices who imported these test strips from EU Member States to Germany. The importer affixed a product label in German and added a German translation of the user manual. The German text was identical to Roche’s German user manual. The sole difference was that the importer’s translation of the user manual gave only the UK measure units mmol/l without the German equivalent mg/dl, while both were given in Roche’s original user manual in the German language. Devices for self-diagnosis including blood sugar measurement devices are qualified as medical devices by the directive (annex II, list B). Their marketing is only allowed when they have received, in one of the Member States, an EC declaration of conformity which covers a full quality assurance and a production quality assurance (the CE-marking). The CE-marking, the German label and a German translation of the user manual are prerequisites for the marketing of these products in Germany to accord with the Medical Devices Act (MPG) implementing the directive 98/79/CE. Roche was of the opinion that the relabeling of the product packaging and reprinting of the user manual in the German language requires a new CE conformity assessment procedure according to annex IV of the directive, because the CE conformity procedure includes the product label and the user manual (in the respective languages). Any relabeling and reprinting comprises the risk of errors and therefore a reassessment of the EC conformity is necessary. The German Federal Supreme Court seems to follow this argument considering that the CE marking is intended to give the security to the patient that the information on the product and the instructions how to apply it are accurate. The present case demonstrates the risk of inaccurate information to a patient when a wrong measure unit is given in the manual of a self diagnosis device; this wrong measure unit would make it impossible for German users to check the accuracy of their blood sugar self-test. But the Court had itself some doubts on this harsh interpretation of art. 16 of the directive 98/79/EC as the German text of the importer was identical to Roche German text (except the measure units) and therefore asked the European Court of Justice for interpretation. If in such circumstances where the product itself (test strips) had successfully passed all conformity tests and where the German translation was identical to the approved German text, must the importer first obtain a fresh CE conformity declaration before he is allowed to start marketing the parallel imported medical device. It should be noted that a second assessment of EC conformity can be based on the results of the first assessment so that only the new elements (label and translation of the user manual in this case) must be examined which is a more formal examination. The legal issue of the question to CJ of the EU does not seem to be very difficult, but the economic impact could be very important for parallel imports of all types of medical devices which need a technical or other examination before being marketed within the EU. This decision of the German Federal Supreme Court is too recent in order to know a reference number of the CJ, but it is definitely worth following up. continued from page 1 US Update the case, compliance with the Guidance is not legally required - the Guidance acts merely as a recommendation to generic drug manufacturers. Nonetheless, a failure to comply may lead to the rejection of an Abbreviated New Drug Application (ANDA) application. As stated on the FDA website, "An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product." This Guidance raises potential trade dress (and patent) concerns. ANDA applicants will look to adopt a similar shape and size for their drugs under the Guidance, but should remain mindful of avoiding the trade dress rights of branded drug owners. See Ross-Whitney Corp. v Smith Kline & French Labs., 207 F.2d 190 (9th Cir. 1953) (holding heartshaped orange and pink drug capsules were eligible for trade dress protection). The tension will be in adopting functional characteristics of a drug's shape or size, while avoiding distinctive characteristics protected by trade dress law. The new Guidance does not discuss the colouring of generic drug tablets and capsules, probably the most important trade dress element. See SK & F, Co. v Premo Pharm. Labs., Inc., 625 F.2d 1055 (3d Cir. 1980) (holding a maroon and white drug capsule was eligible for trade dress protection). Therefore, this source of differentiating trade dress remains available to generic drug manufacturers. 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