You want to start EUDAMED registrations – but can’t⁉️

EUDAMED issue

 

Several times per week we solve this particular problem.

The diagnosis 🔍: The first user registering a company often does not have sufficient permissions to submit device registrations: Confirmer level is needed, but only Viewer level is given. Result: above “Register” buttons are not visible.

The solution ✅: Upgrading the profile to Confirmer level

The catch ⚠️: The request for the upgrade has to be approved by a 2nd user!
NO 2nd user in EUDAMED for your company? No problem.

➡️ It has to be set up first:
A colleague (or MDSS) creates an EU user account and requests access on user manager level to the actor registration. Once that is approved, that 2nd user can approve the profile upgrade request by the 1st user.

This exercise is easily done and takes 15 minutes, the difficult part is knowing that this solution exists. And now you do 😊

Instructions are given in the EU Commission’s user guide 📘 (chapters 2.2.1. & 2.2.6.).

📩 Let’s meet with us to work it through together eudamed@mdssco.com.