IVDR

In Vitro Diagnostic Medical Device Regulation

22.08.2022

As of May 26, 2022, the new In Vitro Diagnostic Device Regulation (IVDR 2017/746/EU) will apply after a 5-year transition period has expired, replacing the previous In Vitro Diagnostic Device Directive (IVDD 98/79/ec). The December 2021 IVDR Amending Regulation does not change any of the requirements in the original 2017 In Vitro Diagnostic Device Regulation (IVDR 2017/746/EU), but merely corrects the effective date from which some of these requirements apply to certain medical devices. Thus, the following extended transition periods apply:

  • for class D products, the deadline for placing on the market has been extended by 3 years and will end on May 26, 2025
  • for class D products, the deadline for placing on the market has been extended by 3 years and will end on May 26, 2026
  • for class B devices (and sterile class A devices), the deadline for placing on the market has been extended by 5 years and will end on May 26, 2027

Our company has already taken steps some time ago to ensure the current and future availability of our products under the new regulation: Our class A products are IVDR compliant. For class B, C and D products, the implementation process to achieve IVDR compliance is ongoing or has already been completed.
It is our ambition to comply with the requirements of the IVDR by the end of the respective transition periods and thus to meet the concerns of our customers by ensuring a continued supply of important, system-relevant in vitro diagnostics.

Questions? Please contact IVDR.

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