Information on CE-IVD Regulation
Amongst others, the following BRAND products are currently registered and marked under the IVDD as IVD products.
• Piston-stroke pipettes (Transferpette®)
• Pipette tips / filter tips
The new IVDR substantiates under which conditions lab products are allowed or required to carry a CE-IVD marking. Several laboratory industry associations such as Spectaris (Germany), GAMBICA (UK), LABMAS (Spain), FHI (Netherlands) and Laborama (Belgium) recommend in a memorandum that the lab products mentioned above should be classified as general labware and must not carry a CE-IVD marking.
Consequently, as of May 2022, BRAND will no longer offer IVD marked piston-stroke pipettes under the Transferpette® brand and pipette tips / filter tips.
BRAND Transferpette® piston-stroke pipettes and pipette tips / filter tips are classified as Products for general laboratory in the future and thus can be sold and used without CE-IVD marking in EU and EFTA countries for general lab applications including IVD applications. Technically, they are identical to the products manufactured previously under CE-IVD Directive 98/79/EG (IVDD) with CE-IVD marking. The premium quality remains unchanged.
The change applies to the following products:
• Transferpette® S
• Transferpette® electronic
• Pipette tips
• Filter tips