Also with the new In-Vitro Diagnostic Medical Device Regulation (IVDR)
Also with the new In-Vitro Diagnostic Medical Device Regulation (IVDR)
In May 2022, the EU IVD Regulation 2017/746 replaces the IVD Directive 98/79/EC under which Centrifuges and selected Eppendorf pipettes, pipette tips and tubes were registered as IVD products. The new IVD Regulation (2017/746) provides more clarity on product types that may be classified as in-vitro diagnostic medical devices. Against this background, leading European Life Science Organizations (GAMBICA, FHI, LABMAS, Laborama, SPECTARIS) recommend that pipettes, pipette tips as well as tubes should generally be classified as general laboratory products.
This approach is already accepted by a large number of authorities, pipette manufacturers and customers. Eppendorf has decided to follow this approach and will therefore discontinue its EU-IVD classified pipettes, pipette tips and tubes that are affixed with the CE IVD mark in the EU & EFTA countries. The production of Eppendorf pipettes, pipette tips and tubes with CE IVD mark will be phased out from January 2022, remaining stock will be sold until 26 May 2022 (or until stock lasts).
To ensure that you can keep working with our products in IVD applications, we will however change the intended use of our “General Lab Product” pipettes, pipette tips and tubes: 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).
Eppendorf pipettes, pipette tips and tubes without CE IVD mark will be manufactured with the same premium quality you are accustomed to and expect and will remain technically identical to the products marked as CE IVD under the IVD Directive 98/79/EC. Eppendorf will continue to operate under an ISO 9001/ISO 13485 certified QM system.
To meet market demand and support your documentation and accreditation requirements where needed, we will continue to offer our centrifuges in two versions: An EU-IVD compliant version for diagnostic applications (affixed with the CE IVD mark according to the EU In Vitro Diagnostics Regulation (IVDR) 2017/746), and a General Lab Product version for research applications.
A broad variety of precision instruments from single-channel pipettes with fixed and variable-volume to multi-channel pipettes with 8, 12, 16 or 24 channels that may be used for research applications in academia and industry as well as for IVD applications (e.g. in a clinical or diagnostic laboratory) in the European Union and EFTA countries.
The perfect combination with Eppendorf pipettes for your liquid handling tasks independent of the type of laboratory. Whether it is basic research, teaching, research and development in industrial laboratories or an IVD application in a clinical or diagnostic lab*: our pipetting system - consisting of Eppendorf pipettes and epT.I.P.S. pipette tips - ensure a level of precision and reproducibility that you can rely on to make your work a success.
Premium raw materials without the use of slip agents, plasticizers, and biocides during manufacturing and their outstanding specifications make these tubes ideally suited for research applications in academia and industry as well as for IVD applications in clinical and diagnostic laboratories in the EU and EFTA countries. Matching accessories for centrifugation, mixing and heating, sample preparation and storage ensure seamless integration into your workflows.
*Scope of applications outside of EU/EFTA depending on local regulations
You can use pipettes without CE IVD mark for all laboratory applications including IVD applications in the EU & EFTA countries. Please refer to this list for a full overview of replacement product numbers. Same as before you have to make sure and document, that your equipment fits your experimental requirements though.
Please refer to this list.
No. They are identical in quality, performance, accuracy and precision. Please refer to this certificate for documentation purposes.
No. The regulatory status of all Eppendorf products that were/are affixed with the CE IVD mark stays as it is. The products may be used accordingly until the end of their lifetime.
Please just use epT.I.P.S.® pipette tips without CE IVD mark. They are identical in quality, performance, accuracy and precision to the tips you previously purchased and are applicable for general lab applications, including IVD in the EU & EFTA countries. You may refer to this list for a full overview of replacement product numbers.
No. Pipette repairs with official spare parts from Eppendorf do not affect the regulatory status, the affected pipette keeps its CE IVD mark and regulatory status.
Please contact your local sales representative for replacement and more information about options for each specific case.
Yes. Eppendorf will continue to provide Preventive Maintenance, Calibration & Adjustment Services for EU-IVD pipettes as before.
All electronic pipettes from Eppendorf will remain to be CE marked based on European Directives (e.g. the Low Voltage Directive (2014/35/EU) and Electromagnetic Compatibility Directive (2014/30/EU) by the European Union).
Since the Multipette M4 and E3(x) multi-dispensers have never been registered as IVD product, their status remains unchanged. The Multipette E3(x) will remain to be CE marked based on European Directives (e.g. the Low Voltage Directive (2014/35/EU) and Electromagnetic Compatibility Directive (2014/30/EU) by the European Union).
Innovative technology, reliable performance and a top level of ergonomic comfort for the separation of samples from the human body in IVD applications in the European Union and EFTA countries.
* The Centrifuge is a non-automatic centrifuge for the separation of liquid substance mixtures from the human body and is specifically intended to be used as an accessory together with an in vitro diagnostic device and to enable its use according to its intended purpose. This product complies with the requirements of the EU In Vitro Diagnostics Regulation (IVDR) 2017/746. Eppendorf centrifuges are exclusively intended for indoor use by trained specialists.
A broad range from low capacity personal centrifuges to high-throughput workhorses for research applications in academia and industry.
Working in clinical diagnostic laboratories usually means working with potentially infectious samples like blood or other bodily fluids. Learn how lab workers are optimally protected.
The precision and repeatability of the pipetting results can be affected when working with liquids of different viscosity, volatility, surface tension or density than water. Choosing the right tool is critical for optimal results. Learn in our Pipetting Facts how to ensure accuracy and reproducibility.
Often been experimental data are not reproducible even though all variables within the procedure have been checked. In many cases the assumption is made that the pipetting system is not a source of error as long as the tip fits on the pipette. But the visible tip fit only does not speak to the precision and accuracy of the pipetting result when working with a pipetting system.