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High-risk Class D assays sold in the EU under the old IVD Directive have until 31 December 2027 to move to the In Vitro Diagnostic Regulation (IVDR).

High-risk Class D assays sold in the EU under the old IVD Directive have until 31 December 2027 to move to the In Vitro Diagnostic Regulation (IVDR). After that date, these legacy devices can no longer be placed on the EU market.

Which assays are affected

Class D is the highest risk class under the IVDR. It includes:

  • HIV assays
  • Hepatitis B (HBV) assays
  • Hepatitis C (HCV) assays
  • Syphilis (Treponema pallidum) assays used for blood screening

Who can still use the transition period

The 2027 deadline comes from Regulation (EU) 2024/1860. It only applies to manufacturers who:

  • Had an IVDR-compliant quality management system in place by 26 May 2025
  • Applied to a notified body by 26 May 2025
  • Signed a written agreement with the notified body by 26 September 2025

Legacy devices also cannot go through significant changes in design or intended purpose during the transition period.

What manufacturers need to show

Performance evaluation for these assays must meet the EU common specifications in Regulation (EU) 2022/1107. These set the requirements for diagnostic sensitivity and specificity, including the number and type of characterised samples that must be tested for each marker:

  • HIV: Annex III
  • HCV: Annex V
  • HBV: Annex VI
  • Treponema pallidum: Annex XI

Under the IVDR, EU reference laboratories also verify the performance of Class D devices and carry out batch testing. This means gaps in the evidence are more likely to be picked up before certification.

What about the proposed IVDR changes?

The European Commission proposed a targeted revision of the IVDR in December 2025. As of October 2026 it is still going through the European Parliament and Council. It does not change the December 2027 deadline, and the current rules still apply.

How AbBaltis can help

AbBaltis supplies characterised disease-state plasma and serum for performance evaluation work, including:

  • HIV positive samples
  • HBV positive samples
  • HCV positive samples
  • Syphilis (T. pallidum) positive samples

We also supply samples for a wide range of other markers.

To receive the full data list for our HIV, HBV, HCV and syphilis samples, email sales@abbaltis.com.

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