18 Jun This time it’s the external values that count
This time it’s the external values that count
While we usually report on the performance or further development of our products and instruments, today we are talking about “external details”. Our labels for all products and the packaging box of the A2® short stem system will change in the coming months. Mario Frank, member of the ARTIQO management and responsible for development, explains what is changing and what lies behind it.
The starting point for changing the labels lies in the requirements of the European Medical Devices Regulation (MDR). With the Unique Device Identification (UDI) system, the European Union makes the labeling of every medical device mandatory. “The UDI system is intended to enable clear and unambiguous identification of the medical devices on the market. The aim is to make it easier to trace individual medical products from the manufacturer to the user – for improved patient safety,” explains Mario Frank. In addition to specifications for the stored data, there are also guidelines for the visual implementation. The changes at ARTIQO mainly affect the appearance: “In our case, the stored manufacturer and product information remained the same. However, we decided to replace the previous bar code with a data matrix code,” says Mario Frank. The advantage: With a data matrix code, less contrast is required for the scanner. “This simplifies the scanning process for our customers.” The new labels for the A2® short-shaft system are expected to begin in September 2024. The other ARTIQO products will then gradually follow.
More robust box for the A2® system
As part of the label adjustment, the packaging of the A2® short shaft system was also optimized. “We close the inner cardboard box with a lid and move the seal label to the inside so that the box is protected in the slipcase,” says Mario Frank, describing the change. The packaging should be more robust.
In preparation: eIFU
For implants, the MDR allows electronic instructions for use (eIFU) to be made available instead of a paper version. “This important step in digitalization helps to reduce environmental impact and makes it easier for us to always provide our customers with the latest version of the instructions for use,” says Mario Frank, describing the advantages. ARTIQO is currently preparing the introduction of eIFU and expects its introduction at the end of 2024.
Neue Kennzeichnung nach Unique Device Identification (UDI) System