Unique Device Identifier (UDI) code capture and traceability
The 3 UDI pillars of medical device labeling
According to the new EU regulations, medical devices must now be labeled. The purpose of labeling is to create complete traceability for medical devices. This labeling is done by Unique Device Identifier (UDI) and consists of 3 pillars.
The UDI product data can be divided into two groups.
Statistical data (Device Identifier - UDI-DI) contain numeric or alphanumeric code, access key for UDI database, identification of manufacturer and product.
Dynamic data (Production Identifier - UDI-PI) contain code identifying the product unit, - consists of serial number, lot number, software identification, manufacturing/expiry date.
TheUDI data carrier (UDI carrier) includes machine-readable labeling (Automatic Identification and Data Capture (AIDC)) on the products and packaging in the form of a bar code or data matrix. Certain data must be in plain text (Human Readable Interpretation, or HRI). This data is located on a label on the product itself and on the packaging.
TheUDI database (Unique Device Identification Database; UDID) is filled with the statistical data of the products. TheUDI database represents a building block of the Eudamed database for medical devices.
The UDI-SYSTEM, abbreviations and important terms
- Unique Device Identifier (UDI)unique product identification or marking of its packaging, is printed by the manufacturer.
- Basic UDI-DIDevice identifier, identifier of a product model
- UDI carrier, barcode for marking on the product packaging
- UDI-PIProduction Identifier, code to identify the product unit, consists of serial number, lot number, software identification, manufacturing/expiry date.
- UDI-DI, numeric or alphanumeric code, access key for UDI database, identification of manufacturer and product.
- Unit of use-DI, for several units of the same product -> Aggregation
- Configurable product, consists of several components
- Configurationa combination of components specified by the manufacturer
- Packaging levels, different levels of product packaging, with fixed quantity of products.
- Shipping container, grouping of several packages enable traceability via logistics systems, no UDI is used here
How does COSYS meet the code capture requirements?
Using the latest scanning technology, data matrix codes and DPM (Direct Part Marking) codes can be captured at all levels of the supply chain. Whether with classic MDE devices or via the camera of mobile devices and smartphones, barcodes can be captured at lightning speed.
Datamatrix codes are attached to the medical devices. Needled DMC codes can also be captured by COSYS special high-performance DPM readers.
UDI Code Scanner at COSYS
Compliance with MDR and IVDR starts with the right hardware. Only professional barcode scanning hardware ensures compliance with EU regulations and allows seamless traceability of medical devices and in vitro diagnostics along the supply chain. By scanning barcodes and data matrix codes, traceability is made possible. Therefore, MDE devices and handheld scanners are of high importance for pharmaceutical companies to meet the requirements of the EU.
With COSYS you have a competent partner who can advise you in detail about the right hardware. In addition to classic MDE devices for harsh working conditions, we also offer you MDE hardware specially suited for the healthcare sector, so that you can meet EU requirements.
Our experts will be happy to take the time to find a perfect hardware solution for you!
In addition to hardware solutions, the camera can also be used to capture UDI COdes. The COSYS Performance Scanning software captures UDI codes at lightning speed, and the smartphone camera can be used to scan the codes.
Turn your smartphones, tablets and wearables into true enterprise-class barcode scanners that can be used in any business environment with COSYS. Image recognition algorithms and the high processing power of smartphones allow codes to be scanned at breathtaking speed and accuracy - significantly faster and better than ordinary barcode scanners.
