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Safely implementing the new IVDR

Our dedicated team of scientific and regulatory experts are continuously working to expand the Chromsystems portfolio under the IVDR.

TÜV SÜD Product Service GmbH has certified our quality management system according to IVDR (EU) 2017/746 for certain device classes. Further product certifications will follow within the defined transition periods. 

Even without immediate CE-IVDR certification, all our existing products remain fully usable as IVD/CE. Thanks to the extended transition periods, they can continue to be sold and used in laboratories without restriction until the full IVDR certification process for all Chromsystems products has been completed.

Safely implementing the new IVDR - ChromsystemsSafely implementing the new IVDR - Chromsystems

New Products under the IVDR

The current status

See here all our IVDR-certified products

New products under the IVDR:

New products under the IVDR – Biogenic Amines by HPLC:

Products under the IVDR in Biogenic Amines by LC-MS/MS:

Current status – Biogenic Amines by LC-MS/MS:

Products under the IVDR in vitamin profiling - the current status:

Current status – Vitamin Profiling:

Products under the IVDR in amino acid analysis (AAA) - the current status:

Current status – Amino Acid Analysis (AAA):

Products under the IVDR in therapeutic drug monitoring - the current status:

Current status – Therapeutic Drug Monitoring (TDM):

Other products already under the IVDR:

Current status – Porphyrin Profiling:

1000-C VMA, HVA, 5-HIAA in Urine - HPLC

1000/B/A1/A5/A9 VMA, HVA, 5-HIAA in Urine, Preparation with the Gilson® ASPEC® - HPLC

2020-B Metanephrines in Urine - HPLC

2020-C Metanephrines in Urine, Combined Analysis - HPLC

2020/A1/A5/A9 Metanephrines in Urine, Preparation with the Gilson® ASPEC® - HPLC

6000-B Catecholamines in Urine - HPLC

6000-C Catecholamines in Urine, Combined Analysis - HPLC

31000 Vitamin B6 in Serum/Plasma/Whole Blood - HPLC

34400 Vitamins A and E in Serum/Plasma - HPLC

35000 Vitamin B1 in Whole Blood - HPLC

44000 Porphyrins in Urine – HPLC

52052 Vitamin B1 in Whole Blood and Vitamin B6 in Whole Blood/Plasma - HPLC

52952/UHPLC Vitamin B1 in Whole Blood and Vitamin B6 in Whole Blood/Plasma - UHPLC

62000 MassChrom® 25-OH-Vitamin D3/D2 in Serum/Plasma - LC-MS/MS

62062 MassChrom® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin-D3 in Serum/Plasma - LC-MS/MS

75222 MassChrom® Amino Acid Analysis in Urine – LC-MS/MS

80700 Sample Prep Set Total Metanephrines (free + conjugated) in Urine - LC/MS-MS

81000 MassChrom® Free Metanephrines in Plasma - LC/MS-MS

92912/XT Parameter Set Neuroleptics 1/EXTENDED - LC-MS/MS

92913/XT Parameter Set Antidepressants 1/EXTENDED - LC-MS/MS

92916 Parameter Set Mycophenolic Acid - LC-MS/MS

92922/XT Parameter Set Antimycotic Drugs/EXTENDED - LC-MS/MS

93000 MassTox® Immunosuppressants in Whole Blood - LC-MS/MS

93900 MassTox® Immunosuppressants in Whole Blood – ONEMinute Test – LC-MS/MS

These products are not available in all countries.

The successive IVDR-certification of further Chromsystems products will occur within the transitional periods determined by the legislature in Regulation 2022/112. Despite close cooperation with our notified body, the requirements are of such complex and comprehensive nature that defining reliable periods for the conversion of individual kits is currently not feasible.

Even if products cannot be provided with the new CE-IVDR certificate for some time, they can still be used in the diagnostic routine as IVD/CE within the permissible scope of the new regulation, since according to the amended transitional periods of the IVDR (Regulation 2022/112) the products may continue to be distributed without restriction until the expiry of the extended transitional periods and deployed by you in the laboratory. Consequently, these products will be available without restriction until all products of Chromsystems have been submitted to the notified body and the conformity certified according to the IVDR. 

Want to know more?

IVDR Fact Sheet Download
Looking at the impact IVDR will have on laboratories and manufactureres

IVDD and IVDR - FAQ
We do our best to answer the most common questions on the topic

What benefits does IVDR bring to manufacturers and laboratories?
An article about the challenges and opportunities of the new regulation

Official Journal of the European Union: Regulation (EU) 2017/746 of the European Parliament and of the Council

European Commission Fact Sheet for Manufacturers of In-Vitro-Diagnostic

Further questions?

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