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. 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. 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.