In May 2022, the EU IVD Regulation (IVDR) 2017/746 replaces the IVD Directive 98/79/EC under which a variety of Eppendorf products were registered as IVD products. The new IVDR, and resulting recommendations from leading European Life Science Organizations, provide more clarity on product types that may be classified as in-vitro diagnostic medical devices, which will lead to some changes in our IVD product portfolio.
Eppendorf will continue to offer centrifuges in two versions: An EU-IVD compliant version for predominantly medical, clinical or diagnostic applications (affixed with the CE IVD mark according to IVDD (EU) 98/79/EC, and, in the future, according to the IVDR (EU) 2017/746), and a General Lab Product version for research applications.
Eppendorf pipettes, pipette tips and tubes affixed with the CE IVD mark will be discontinued in May 2022. To ensure that you can keep working with our products in IVD applications, the intended use of our "General Lab Product" pipettes, pipette tips and tubes will be changed however: Eppendorf pipettes, pipette tips and tubes without CE IVD mark will be suitable for all general laboratory applications including IVD applications and may be purchased and used as such from January 2022 (in the EU and EFTA countries).
Learn more here