Announce the discontinuation of the CE-IVD certification for our Biosan pipettes Assist series
We would like to inform you about an important update regarding our Biosan pipettes Assist series.
Due to changes in the European In Vitro Diagnostics Regulation (EU-IVD) 98/79/EC which is replaced with 2017/746, we regret to announce the discontinuation of the CE-IVD certification for our Biosan pipettes Assist series. This decision is in alignment with the new regulatory requirements and standards.
In accordance with the new In Vitro Diagnostic (IVD) Regulation 2017/746, which offers enhanced clarity regarding the classification of in-vitro diagnostic medical devices, several prominent European Life Science Organizations (GAMBICA, FHI, LABMAS, Laborama, SPECTARIS) advocate categorizing pipettes, pipette tips, and tubes as general laboratory products. This recommendation, supported by numerous authorities, pipette manufacturers, and customers, has gained wide acceptance.
Biosan has chosen to align with this approach and will consequently discontinue the classification of its pipettes as EU-IVD certified since May 2022. This discontinuation affects Assist series single and multi-channel pipettes bearing the CE IVD mark in both the EU and EFTA countries.
This decision ensures compliance with the new IVD Regulation (2017/746) and acknowledges the prevailing consensus within the life sciences community. It allows Biosan to continue providing high-quality laboratory products while meeting evolving regulatory standards.
For detailed information on these changes, you can refer to the official IVD Regulation (2017/746) document on EUR-Lex and related guidance documents provided by the Medical Device Coordination Group. Additionally, Biosan encourages you to visit their official website for any specific inquiries regarding these product changes.
We understand that you may have questions or concerns about this change. For more detailed information and any inquiries, please contact your sales manager.
We value your continued trust in Biosan products and are committed to providing you with the highest quality liquid handling solutions.
Thank you for your understanding and continued partnership.