IVDR

IVDR

All CE-IVD-marked RECIPE products comply with IVD-Directive 98/78/EC (IVDD).

The IVDD was repealed by Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) on 26.05.2022.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 according to EU Regulation 2024/1860 for these products will end on 31.12.2029 for risk class B and on 31.12.2028 for risk class C. All RECIPE products are valid under IVDD until the end of the grace periods.

RECIPE devices are IVDR compliant according to Regulation (EU) 2017/746 on in vitro diagnostic medical devices, Annex IX, Chapters I and III (BSI EU IVDR certificate no. 759872).

RECIPE IVDR compliant devices (as of 26/03/2025):

Order no.      Device name

1000                ClinRep® Complete Kit for Catecholamines Plasma

2000                ClinRep®  Complete Kit for Catecholamines Urine

3500                ClinRep®  Complete Kit for VMA, HVA, 5-HIAA in Urine, advanced

4500                ClinRep® Complete Kit for Metanephrines in Urine, advanced

14000              ClinRep®  Complete Kit for Antiepileptics in Serum and Plasma, advanced

14100              ClinRep®  Complete Kit for Antiepileptics in Serum and Plasma by UHPLC

17200              ClinEasy® Complete Kit for 5-Aminolevulinic Acid and Porphobilinogen in Urine

17300              ClinEasy® Complete Kit for Porphobilinogen in Urine

21000              ClinRep® Complete Kit for CDT (Carbohydrate-deficient Transferrin) in Serum

21100              ClinRep® Complete Kit for CDT (Carbohydrate-deficient Transferrin) in Serum, on-line analysis

21200              ClinRep® Complete Kit for CDT (Carbohydrate-deficient Transferrin) in Serum, on-line analysis, automated

24000              ClinRep®Complete Kit for Vitamin B1 in Whole Blood

25000              ClinRep® Complete Kit for Vitamin B2 in Whole Blood

26000              ClinRep® Complete Kit for Vitamin B6 in Whole Blood/Plasma

27000              ClinRep® Chromatography Kit for Vitamins B1, B2 in Whole Blood and Vitamin B6 in Plasma/Whole Blood

27001              ClinRep® Sample Preparation Kit for Vitamin B1 in Whole Blood

27002              ClinRep® Sample Preparation Kit for Vitamin B2 in Whole Blood

27006              ClinRep® Sample Preparation Kit for Vitamin B6 in Plasma/Whole Blood

35000              ClinRep® Complete Kit for Vitamin D2/D3 in plasma/serum

35100              ClinRep®  Complete Kit for Vitamin D2/D3 in plasma/serum by UHPLC

MS1100         ClinMass® Complete Kit for Immunosuppressants in Whole Blood, advanced, on-line analysis

MS1200         ClinMass® Complete Kit for Immunosuppressants in Whole Blood, advanced, automated on-line analysis with LHS (well plates)

MS1300         ClinMass®  Complete Kit for Immunosuppressants in Whole Blood, advanced, automated on-line analysis with LHS (well plates/filter plates)

MS7000         ClinMass®  Complete Kit for Vitamin D2/D3 in Plasma and Serum; on-line analysis

MS7100         ClinMass®  Complete Kit for Vitamin D2/D3 in Plasma and Serum; automated on-line analysis with LHS (well plates)

MS7200         ClinMass®  Complete Kit for Vitamin D2/D3 in Plasma and Serum; automated on-line analysis with LHS (well plates/filter plates)

MS9500         ClinMass® Add-On Set for Benzodiazepines in Serum/Plasma

MS10000       ClinSpot®  Complete Kit for Amino Acids and Acylcarnitines in Dried Blood Spots (DBS)

MS10100       ClinSpot®  Complete Kit for Amino Acids and Acylcarnitines in Dried Blood Spots (DBS) with Filter-Plates

MS10200       ClinSpot® Complete Kit for Amino Acids and Acylcarnitines in Dried Blood Spots (DBS), non-derivatised

MS10300       ClinSpot®  Complete Kit for Amino Acids and Acylcarnitines in Dried Blood Spots (DBS) with Filter-Plates, non-derivatised

MS11000       ClinMass®  Complete Kit for Free Metanephrines in Plasma, on-line analysis

MS11100       ClinMass®  Complete Kit for Free Metanephrines in Plasma

MS13000       ClinMass® Complete Kit for Vitamins B1, B2 in Whole Blood and Vitamin B6 in Plasma/Whole Blood

MS99200       ClinMass® Add-on Set for Immunosuppressants in Whole Blood