IVDR

All B.S.N. products with the CE-IVD marking comply with the IVD Directive 98/78/EC (IVDD). The IVDD was repealed by the EU IVD Regulation 2017/746 (IVDR) on 26.05.2022.

Transitional provisions were implemented in the IVDR by Regulation (EU) 2024/1860. As a result, risk class-dependent grace periods were granted, which allow manufacturers to place IVDD-compliant products on the market at a later date.

All B.S.N. products are of risk class B or C. The grace periods for these products will end on 31.12.2029 for risk class B and on 31.12.2028 for risk class C. All B.S.N. products are valid according to the IVDD until the end of the grace periods.