What do I have to consider when selling CE-marked products?
In accordance to the 98/79/EC Directive of the European Parliament and the Council in-vitro diagnostica must be marketed within the European Union with CE-mark only since December 6, 2003. The Medical Products Law requires the distributor of such products to act as a medical consultant to his customers and notify the manufacturer of any grave incident caused by his products. An incident is considered as grave if humans have sustained significant damages to their health when using an IVD product. IVD products have to be traceable and, therefore, the products or their packaging have to bear a production lot number, the address of the manufacturer and - when applicable - an expiry date. IVD products have to be traceable through the whole supply chain from the manufacturer to the end user, because the manufacturer must be able to call back all products of a possibly defective production lot in case this has caused grave incidents.