EUDAMED Actor Registration: What Distributors Need to Know

If your company imports OC Orthodontics products into the European Union, it’s time to prepare for EUDAMED Actor Registration.

Under the EU Medical Device Regulation (MDR), all importers will soon be required to register in the EUDAMED Actor Module. While registration has been voluntary since 2020, the European Commission is expected to make it mandatory in early 2026, once the system is officially declared fully functional.

Registering early is the best way to ensure a smooth transition and avoid any potential shipping delays when the requirement takes effect.

Who needs to register:

• Any distributor or partner that imports OC products into the EU.

  
  

Once your registration is complete, please share your EUDAMED Single Registration Number (SRN) with sales operations: ashley.s@oc-orthodontics.com.

We’re happy to help answer any questions!