DGM just issued our first certificate for CE marking of IVD devices to the Dutch company Organon Teknika b.v.
The certificate is a milestone for both Organon Teknika b.v. and DGM, and is the result of an intensive cooperation between the company on the one hand and DGM, Statens Serum Institut and Paul-Ehrlich-Institut on the other.
With this certificate Organon Teknika is the first company in the world obtaining both CE marking and FDA approval of a HIV test kit enabling the company to market the product in both the US and Europe.
The IVD directive is a new EC directive and a new field of business for DGM.
