In May 2022, the EU IVD Regulation 2017/746 replaces the IVD Directive 98/79/EC. Micronic tubes were developed and supplied with this Directive as guidance. 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 many authorities, manufacturers and customers. Micronic has decided to follow this approach.
Micronic products without CE IVD mark will be suitable for all general laboratory applications and may be purchased and used as such from January 2022 (in the EU and EFTA countries). Micronic Sample Storage 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. Micronic will continue to operate under an ISO 9001/ISO 14001 certified Management system.