We are the MDR Eudamed specialists
MDR-Eudamed is an application that will be used by in excess of 80,000 manufacturers, sponsors, importers, authorised representatives and competent authorities. The European Commission will manage this application. The projections are that there could be 300,000+ users.
Every organisation and user will have different ideas as to what is expected and required by the application. Eudamed.eu would like to bring interested groups of users together to share their different experiences, to learn more about the system and the future plans for the system, and finally to try and influence the direction of the system.
In 2019, we plan to hold several one-day conferences at which we will cover subjects such as first registration of your organisation, adding and managing users, the required validation by a competent authorities and by an EC based authorised representative for non-EU manufacturers.
We will give an overview of the application, adding UDIs and device packaging, linking to certificates and several more informative sessions. These conferences will help inform your users and your administrators of what this incredibly large system, MDR-Eudamed, means for your organisation.
These one-day conferences will be followed by optional hands-on training sessions covering, management of the system, adding devices, and separate training sessions on preparing your data for uploads. Machine-to-machine uploads or uploads via the MDR-Eudamed GUI require a complete understanding of the XSD requirements, structures and the additionally complex business rules.
You can influence our conference locations, page down and complete our short conference survey.