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IVDR status and progress of our certification

The EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) came into force on May 26, 2022 and replaces the previous Directive 98/79/EC (IVDD). This new regulation significantly increases the requirements for documentation, clinical evidence, conformity assessment, transparency and traceability of IVD products. The aim is to increase patient safety and create uniform standards for the quality and conformity of diagnostics across Europe. For manufacturers, this means stricter test criteria, more official controls and a risk-based classification of all diagnostics (classes A to D). In the field of immunodiagnostics, we are implementing these requirements with the highest priority.

Quality and patient safety are our top priorities - our commitment to quality, compliance and scientific validity is firmly anchored in our corporate culture. With a consistent investment program in our quality management, regulatory expertise and clinical evidence, we ensure that our products remain reliable, safe and compliant under IVDR. On this page we keep you up to date on the progress of our IVDR certifications.

Certified quality as a basis – our quality management system already meets the requirements of ISO 13485:2016 and the MDSAP (Medical Device Single Audit Program). In 2023, our QM system was officially certified as compliant with the IVDR – a significant milestone. This solid foundation allows us to continue the compliant development, production and marketing of our diagnostics under the new regulatory framework, fulfilling not only European but also international regulatory requirements.

Progress in product certification

  • Class A products:
    100% of our risk class A products are IVDR-compliant

  • Higher class products (class B-D):
    More than 100 products from our portfolio are currently in the certification process with notified bodies. These include:

    Groups with already declared IVDR conformity
    Products of class B IVR group 0608 (Immunoassays for screening, determination or monitoring of physiological markers for a specific disease in human blood, serum, plasma, stool and urine) and products of class C group W0106 + IVP3011 (In vitro diagnostic PCR kits intended for human genetic testingincluding the determination of risk factors for genetic disesases and diagnosis of allergies and intolerances)

    e.g.:
    • ReFiNE® DKK3 ELISA
    • SelenOtest ELISA
    • IDK® TNFα ELISA
    • IDK® MPO ELISA
    • Hepcidin-25 LC-MS/MS
    • 1,25(OH)₂-Vitamin D₃/D₂ LC-MS/MS (calibrators & controls also available as CE-certified single components)
    • MutaGENE Faktor II PCR

  • Other groups in the certification process
    Class B products: Gruppe IVR 0603 and IVR 0504
    Class C products: W0103 + IVP3007, W0104 + IVP3011, W0106 + IVP3011, W0105+IVP3011, W010208+IVP3007

    Our goal: 90% of our core portfolio will be IVDR-certified by the end of 2026.
    With the IVDR certification of our core range, we ensure the seamless availability and marketability of our diagnostic solutions, which you have been relying on for years.

  • Scientifically based performance
    Strong scientific basis:     The performance of our assays is proven by over 1,000 scientific publications. This evidence base not only facilitates IVDR assessment, but also provides our partners with long-term scientific certainty and confidence in our products.

  • Production sites successfully audited
    Our production sites have also successfully passed the IVDR audits. This means that, in addition to development, our production processes have also been officially validated and meet the new regulatory requirements - further proof of our quality assurance along the entire value chain.

  • IT security
    All IT processes are currently being prepared for ISO/IEC 27001 certification in order to ensure the highest standards in the area of information security.

Our quality and compliance promise

You can count on it: Every product we supply complies with the applicable legal requirements. We assure you that all in-vitro diagnostics delivered to you comply with the applicable legal requirements – now and in the future. Should there still be products with IVDD labeling in individual cases due to the current transition periods, this only concerns formal aspects. Every product you receive from us is technically and qualitatively up to date. The complete safety and efficacy of our diagnostics are our top priority. We work closely with the notified bodies to obtain all relevant certifications on time. In this way, we guarantee seamless supply without any loss of quality during the entire transition phase.

Stay informed
We regularly update this page with the current status of our IVDR transition. This will keep you up to date on certifications, product releases and regulatory developments.

Further information on transition periods and more can be found in our FAQs on IDK and IVDR

Certificates

Certificate ISO 13485

MDSAP Certificate