We have officially started the IVDR certification process for our LC-MS/MS product portfolio. Following recent agreement with our Notified Body (BSI), we aim to complete the full certification under the In Vitro Diagnostic Medical Devices Regulation (IVDR) by mid-2027. This timeline is subject to change depending on the progress of the certification procedure.


The IVDR scope includes calibrators, controls, internal standards and diagnostic kits, classified as risk class B and C. These include the following products:


Risk Class B
Vitamin A & E
Vitamin B1 & B6
Methylmalonic Acid
Steroids Basic Panel

Risk Class C
Cortisol & Cortisone in urine (Dilute & Shoot / SPE method)
Metanephrines in plasma
Immunosuppressants in whole blood
Psychotropic Medication 1
Psychotropic Medication 2
Psychotropic Medication 3


As part of the IVDR process, our products undergo comprehensive analytical validation, appropriate to their risk classification. Users are welcome to contact us for more information on validation data and supporting documentation.


During the transition from IVDD to IVDR, these products retain their current CE-IVD status, in accordance with applicable legislation.


We are also committed to continued innovation in LC-MS/MS diagnostics. New products are introduced as Research Use Only (RUO) and, where feasible, are already being designed with future IVDR certification in mind.


For further information on the IVDR transition, please visit the IGJ website
For any questions about our products or regulatory process, feel free to get in touch