What is an MDR Declaration of Conformity?
The MDR Declaration of Conformity is a document confirming which materials were used in producing a piece of dental work — including batch number, catalog number, and manufacturer. It's part of the legal documentation requirement under the EU Medical Device Regulation (MDR) and is handed over to the practice along with the finished work.
How to create a declaration of conformity
You'll find the MDR Declaration of Conformity menu item within an order, in the three-dot menu in the top right, as soon as your order is in the "In-Progress" status.
Open the order.
Make sure at least one material batch is assigned to the order. Learn how in Add material batches to an order.
Open the order submenu via the three-dot icon.
Select MDR Declaration of Conformity.
The document is generated and is ready for download immediately.
The declaration of conformity is saved in the order under Files → Media & Documents. The practice can download it there directly — you don't need to send it separately.
Tip: For your logo to appear on the declaration of conformity, it needs to be set under Settings → My Business → Business Details. Learn how in Upload your logo.
FAQs
Is the declaration of conformity created automatically?
No. You create it manually via the three-dot icon in the order. The menu item only appears once the order is in the "In-Progress" status and at least one material batch is assigned.
Where does the practice see the declaration of conformity?
The practice finds the document in the order under Files → Media & Documents — directly in their customer portal, once you've generated it. You don't need to send the declaration of conformity separately.
What happens if no material batch is assigned to the order?
In that case, the MDR Declaration of Conformity menu item can't be selected. First add the material batches used — learn how in Add material batches to an order.