As an international leading supplier of high-quality laboratory instruments and consumables, Sartorius is implementing measures on an ongoing basis to improve the quality of its products and services. This letter is to inform you about a change of labeling for the CE-labeled Minisart® product portfolio. Within the framework of the new Medical Device Regulation (MDR, 2017/745) we will face changes due to increased regulatory requirements.
To comply with the new regulation, Sartorius has revised label and instructions for use of the CE-labeled Minisart® product portfolio. In this context we would like to achieve a clear distinction between the CE-Minisart® and the standard Minisart product portfolio therefore we make layout changes in the marketing material. Furthermore, for better traceability, UDI-code is implemented on the labels.
Read more about the changes in the official document of the manufacturer.