In Vitro Diagnostic Regulation Update


Immundiagnostik has been implementing the European Regulation on In Vitro Diagnostics (IVDR 2017/746/EU). Our company continues to ensure the current and future availability of our products under this regulation.

View our progress!

  • By successfully mastering the first IVDR audit, we have proven our effectiveness and compliance with the requirements of the IVDR and thus created the basis for the development, production and distribution of our products according to IVDR.
  • Our QMS is also MDSAP certified (Medical Device Single Audit Program) according to ISO 13485 : 2016.
  • 100% of our Class A products are IVDR compliant!
  • We are seeking IVDR certification for our products, assuring the continued availability of our important in vitro diagnostics: We have over 100 in vitro products scheduled for IVDR certification!
  • The clinical validity of our products is based on strong scientific research, as evidenced by over 1000 clinical publications.
  • Our two manufacturing sites successfully completed their IVDR QMS audits.

We will continue to keep you informed about the latest developments!