All CE-IVD-marked RECIPE products comply with IVD-Directive 98/78/EC (IVDD).The IVDD was repealed by IVD-Regulation EU 2017/746 (IVDR) on 26.05.2022.
Transitional provisions have been implemented in the IVDR by Regulation
(EU) 2022/112. As a result, risk class dependent grace periods were granted, which allow manufacturers to place IVDD-conform products on the market further on.
All RECIPE products are risk class B or C. The grace periods for these products will end on 26.05.2027 for risk class B and on 26.05.2026 for risk class C. All RECIPE products are valid under IVDD until the end of the grace periods.
In addition, RECIPE products are IVDR-ready and currently under technical assessment by the Notified Body BSI (British Standards Institution).