Milestone reached for IVDR
First products under the IVDR
As an important milestone, Chromsystems has received its IVDR certification from its notified body, which already covers the IVDR conformity for the first products.
The certification body of Chromsystems, TÜV SÜD Product Service GmbH, has certified that Chromsystems has introduced, documented and implemented a quality management system according to the IVDR (Article 10  of Regulation (EU) 2017/746 on in vitro diagnostic medical devices). The documentation was accompanied by an examination of the technical documentation for representatively selected products.
The first IVDR-certified assays:
- 44000 Porphyrins in Urine – HPLC
- 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
- 81000 MassChrom® Free Metanephrines in Plasma - LC/MS-MS
- 92922/XT Parameter Set Antimycotic Drugs/EXTENDED - LC-MS/MS
The certification of all other Chromsystems products according to the IVDR will occur successively within the transitional periods determined by the legislature in Regulation 2022/112. Despite close cooperation and coordination with the notified body, the IVDR requirements are so complex and comprehensive that stating periods for the conversion of individual kits is currently not possible.
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.
We are working flat-out to transfer more product series as quickly as possible to IVDR conformity.
Last Update 31st of Oktober 2022
IVDD and IVDR - your questions, our answers (Artikel, Chromsystems-Webseite)
Official Journal of the European Union: Regulation (EU) 2017/745 of the European Parliament and of the Council
European Commission Fact Sheet for Manufacturers of In-Vitro-Diagnostic