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The new European Medical Device Regulation defines the requirements regarding conformity assessment of medical devices.
It combines the Medical Devices Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC) with the objective of implementing a higher standard and further increasing the focus on patient safety.
Under the Unique Device Identification (UDI) system, medical devices must bear a globally unique product number that is machine readable and included on the product and/or packaging, for example in a barcode. This code acts as a key for a UDI database (UDID) that contains various details about the products.
Using the UDI improves the documentation and traceability of the materials used. The number enables information to be traced, such as the manufacturer of the medical device, product, manufacturing date and the production batch.
Documentation on delivery notes or invoices is not required, as the products are frequently removed from storage and the batch number only needs to be documented when processing is carried out.
1. VITA veneering and CAD/CAM materials
All VITA veneering and CAD/CAM materials bear a UDI-compliant Health International Bar Code (HIBC) that contains all the required information, either in digital form or in plain text. All units produced (e.g., bottles or blocks) are labeled with a batch number. The scannable barcode is provided on the primary packaging of the product.
2. VITA prosthetic teeth
Our tooth sets are also labeled with a UDI-compliant Health International Barcode. Every tooth set includes a verified and approved tooth batch that ensures correct batch traceability. As the risk class is low, batch identification is not required for each individual tooth.
Set on which the teeth are mounted have a lot number. Individual denture teeth do not have LOT numbers. In order to ensure the required traceability, the lot number of the set must be recorded when the denture is manufactured.
If the field cannot be left blank, enter a fictional future date, e.g., 1/1/2071.
For the traceability of denture teeth, the designation (product name), shade, shape and lot number must be written down. For all other medical devices, the product number and lot number are sufficient for documentation.
To facilitate documentation, we recommend using a documentation software. Using a barcode reader, all UDI-compliant HIBC information on the medical devices can be scanned, transferred to the documentation soft-ware and saved.
Manual documentation of the product number and batch to ensure sufficient traceability, can also be carried out without a barcode reader.
We do not attach adhesive labels, as this is not a sustainable solution and would require management of vast quantities of labels, given the large number of components.
You can conveniently download and manage declarations of conformity in our MyVITA online portal.
Simply register at www.vita-zahnfabrik.com/MyVITA-Register
In the "Declarations of conformity" section, you can access the service "Automatic updates for your declarations of conformity." If requested, your selected VITA declarations of conformity are updated automatically. You will also be informed via email when a new version is available.