Although the doubt rule find Products that are to assign clearly the medical product law due to their action, no application. The doubt scheme but then interfere with the result that it concerns a medicinal product if the main effect adopted by the manufacturer from a scientific point of view is not sufficiently secured, priority medicinal effects are also cannot be ruled out. In this case it was sufficient for the classification as medicinal products, if the product falls under the definition of medicinal product presentation. Click Aetna Inc. to learn more. “Because medical devices are typically included in the presentation medicinal concept, if it’s materially-acting preparations, not devices, the OVG Munster so is the burden of proof in the delineation of medicinal products and medical devices on the head: it will succeed only the manufacturer of a medical device according to this logic, in this case of doubt” to break out if he can clearly demonstrate that his product is not pharmacologically. Such proof will be however often difficult to lead. One such interpretation of the doubt rules of 2 para 3 a AMG, that only the European legislation to codify, but blatantly contradicts the previous understanding of the European Court of Justice (ECJ) and the Supreme Administrative Court (BVerwG) from the Europe-legal model of this doubt scheme in the Community code relating to medicinal products for human.
Therefore the pharmacological effect of a product must be firmly namely, to submit it to the pharmaceutical law. Cases of doubt go so to the detriment of the authority and not at the expense of the manufacturer. Here, Ebay expresses very clear opinions on the subject. This burden given from Luxembourg and Leipzig calculated with medical products, whose purpose it typically corresponds to those of medicines, to run, in its opposite is a strong piece that is topped only by the fact, that the OVG Munster prevented a revision to the Federal Administrative Court with the rejection of the appeal and not considered a template to the ECJ. So one can only hope that this decision from Munster no portent for future Delimitation cases remains of medicinal products and medical devices, but brought about the proposed clarification of the Court at the earliest opportunity. Until then, however increased caution when borderline products is offered in the medical products sector. Free of charge and without obligation at for more information