Safely implementing the new IVDR
An ever growing team of dedicated scientific and regulatory experts is working continuously to increase the amount of products offered by Chromsystems under the IVDR.
TÜV SÜD Product Service GmbH, the notified body assigned to Chromsystems, certified that a quality management system pursuant to Regulation (EU) 2017/746 on in vitro diagnostic medical devices, Annex IX, Chapters I and III (Class C and B devices excluding self/near-patient-testing and companion diagnostics) had been successfully implemented by Chromsystems.
Products under the IVDR
The current status
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
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
Latest Update 09.04.2024
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
European Commission Fact Sheet for Manufacturers of In-Vitro-Diagnostic
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