What is MDR material batch tracing
The EU Medical Device Regulation (MDR) requires dental labs, among other things, to document the consumable material used per order — so that in the event of a recall, it can be traced which patients received a particular material.
Without digital support, that means: entering lot numbers into lists by hand, creating declarations of conformity manually, and laboriously looking up batches in spreadsheets. With Crownbeam, this runs directly within the order — from scanning the material packaging to the finished declaration of conformity for the practice.
The four MDR features
Recording material batches
For every order, you can record the material batches used directly in Crownbeam. In the best case, the barcode on the material packaging contains all the necessary info — Crownbeam reads it automatically when scanned. Alternatively, you can also type in the lot number manually.
Materials recorded once stay saved in the Crownbeam material database. The next time you use the same batch, the material is recognized automatically and suggested — you don't need to type anything in again.
Learn how in Add material batches to an order.
MDR Declaration of Conformity
Once material batches are assigned to an order, you can manually generate an MDR Declaration of Conformity. The document contains the recorded batch data and your lab's logo — it's saved in the order and is also available to the practice via the customer portal.
You'll find the download in the order via the three-dot icon in the top right. Learn how to create a declaration of conformity in Create an MDR Declaration of Conformity.
Batch tracing
Under Dashboards → MDR in the top navigation bar, you'll see an overview of all orders along with the material batches used in each. This lets you quickly search for an affected material in the event of a recall and trace which patients it's relevant for.
To search for a specific material, enter the material's lot number or catalog number (REF) in the search field in the top left — these values are shown as columns in the MDR dashboard and are therefore searchable. The material name itself isn't a separate column by default and so isn't directly searchable.
More on dashboards in Crownbeam is in Understand and use dashboards.
Event protocol
The MDR requires dental technicians and dentists to fully document a patient's treatment and its course. Crownbeam supports you with the event protocol. Every change to an order is automatically recorded there — who changed what and when. The event protocol sits in the chat in the top right of every order and is collapsed by default.
FAQs
How exactly do I record material batches?
The step-by-step guide is in Add material batches to an order.
What happens if a material isn't recognized?
Crownbeam shows an error message. You can then add the material manually — it's then saved in the database and automatically recognized going forward. What the exact error messages mean is explained in Why isn't my material recognized?
Does the practice see the declaration of conformity automatically?
Once you've created the declaration of conformity, the practice can download it directly in the order, under Files → Media & Documents.
