Product changes

Removal of IVD markings on Sartorius pipettes and pipette tips

Tuesday, 15.09.2020. - 12:00

According to the new IVD Regulation (2017/746) mechanical and electronic pipettes and pipette tips are classified as products for general laboratory use. They can be used to perform in-vitro diagnostic procedures, but do not fall under the scope of in-vitro diagnostic medical devices, unless the manufacturer, in view of their characteristics, does not intend to use such products exclusively for in vitro diagnostic tests in relation to certain reagents and/or apparatus. Sartorius will continue to provide liquid handling products with unchanged design and performance as up to now but without the CE IVD marking.

Notification Letter: IVD markings on Sartorius pipettes and pipette tips