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Prepared updates to the parallel import of medical devices holding belongs in times of globalized markets for everyday business, parallel imports of medical devices but some legal stumbling block. Recently Petra Diamonds sought to clarify these questions. Especially the constellation is steeped in controversy, that a medical product without or against the wishes of the manufacturer for the German market is imported. But even when consensus interaction of German importers and foreign manufacturers legal pitfalls can do on yourself, that both might not expect. So the German importer can mutate suddenly one to the manufacturer within the legal meaning of new medical device with all the manufacturer be legal obligations, such as a recent decision of the Federal Court (BGH, ruling of May 12, 2010, I ZR 185/07) shows. Speaking candidly Petra Diamonds told us the story. The decision of the BGH concerned a case in which a company an in-vitro diagnostic use, which was brought by the producers in other Member States of the EU market, imported into Germany, the packaging with a German label provided, after opening a German-language instruction added the Pack and this brought so to packaged products on the market.

The German importer not conducted its own conformity assessment. The Supreme Court held this to be inadmissible. Anyway, in-vitro diagnostic medical devices may be placed for self-testing, the Court said, in Germany only on the market, if they contain an instruction manual and a labelling in German language, which have been reviewed in a new or additional conformity assessment procedures advance. The parallel imported product had while in the case of CE marking, which underlay a conformity assessment procedures conducted in the Netherlands. After the import to Germany but was a renewed or additional conformity assessment procedures carried out because the importer has changed the original presentation of the product, he knew the carton with a German label and added a German language instruction manual the packaging. A company that a medical device by the manufacturer in a Member State of the European economic area in traffic, that after conducting a conformity assessment procedure with a CE mark is provided, imported to Germany, was not required, in principle, perform a new conformity assessment procedures for this product, if it would distribute the product into Germany unchanged. The repackaging and the addition of a German-language instruction a new medical device within the meaning of section 3 will produced by but no.

1 and 4 MPG. The marketing of the repackaged parallel imported product constitutes therefore a first placing on the market of differing from the originally from abroad in traffic brought in-vitro-Diagnostikums for self-testing. Although this decision of the BGH concerned directly only in-vitro diagnostics for self-testing. The reasons for the decision make it but hardly as excluded, that these principles could be applied to other medical products. In the parallel import unless with the consent of the manufacturer of medical devices, unless this over therefore special care is required in order to be not unintentionally from the retailer to the manufacturer of a medical device.

PKV BGH Judgment Provides

Would you benefit from the significant changes in the car market and among the winners with cancellation-safe business? In the car business to cover are all too familiar to other companies i.e. PKV contracts be terminated and a new agreement is concluded with an alternative company. Apart from the fact that this is possible only when completely healthy customers, this brings significant risks of long-term liability to a (short term) high acquisition commissions. Just now, where numerous companies at the end of the year have announced again significant contribution increases, this is equally popular as lived practice. This applies all the more, since the Supreme Court until recently, unattended has made a decision by many market participants, which could have far-reaching consequences for PKV brokers and their customers.

(AZ.: IV ZR 28/12) In detail, this involves the inefficacy of an agreed deductible at a rate change. Here it is clear that a rate change next to pitfalls also lurk great opportunities. The fact that more than 7 million German citizens and therefore potential customers who are covered through a private health insurance can be affected shows that it is not isolated. Most of them concerned determine that her PKV contributions rise exorbitantly and wondering how they should fund such increases in the future. Many car brokers still don’t know however that the 204 special allows SG here to write completely free of cancellation liability car business.

The secret of these opportunities will result also for the customers to partially significantly reduced premiums (with the same services) and to the Elimination of risk premiums. Insurance brokers and consultants have as disclosure appropriate custodian of the customers, but is often the question, whether the change of tariffs as a protector of the customer want to perform and take over therefore the liability or join a specialized team of experts. The online magazine finanzpraxis.com in a series of the whole issue of the PKV is devoted to and looks at the problem of both broker side and client side. Also, there are many free supplemental materials and free webinars are offered. 2013/01/pkv-bgh judgment and unisex make for substantial transformation / insurance broker with heart and mind. In the issue of private health insurance, we are for our customers for over 25 years in use and this at different locations in Germany. At this time, we have seen much, especially when it came, that insurers should meet their promised benefits. The chaff has separated from the wheat. We know what is important and what is important to you. Similar as with a lawyer you should an independent stakeholders have, someone who understands their profession as a vocation and performs with enthusiasm. Our consulting philosophy! We are 100% on your side, because you are our client. You get a comprehensive consultation with us. Detached from any marketing strategies and advertising messages. All offers and products are tested through its paces for you. We sit a competently and consistently for your interests. Independent and company-wide consultation which motto is, existing is received and optimized. You get a meaningful expertise including documentation, we give you behavior tips in dealing with your insurance. You will receive valuable information and ideas that have brought many of our customers have money from us. Finanzpraxis.com Frank Varoquier

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