IVD: Access to the European Market

Manufacturers and authorized representatives located outside of Germany must submit their notifications to their competent authorities. In order to bring their products to the market in Germany, they no longer need to notify them here as well. As of 1 May 2011, this notification has been assumed by the European database EUDAMED. The competent authorities of the Member States are obligated to forward notifications received by them to this database (according to Article 10 (5) of the European Directive 98/79/EC on in vitro diagnostic medical devices).

Before the creation of this European database, manufacturers or authorized representatives had to submit their notifications to the competent authorities of all Member States that were affected by the placement of their products on the market (according to Article 10 (6) of the Directive 98/79/EC on in vitro diagnostic medical devices). In Germany, DIMDI accepted these notifications on behalf of the Federal Ministry of Health.