New EU regulation for in-vitro diagnostics – the end of laboratory-developed tests?

Following on from the EU regulation for medical devices (MDR) that came into force over one year ago, this week I am focusing on the EU regulation for in-vitro diagnostics (IVDR).

Regulation for in-vitro diagnostics (IVDR)

In May 2022, the EU has introduced a new regulation for in-vitro diagnostics. This new IVDR included legislation to end the use of laboratory-developed tests. These tests can only be used until May 2028.

Afterwards, only industry-developed tests can be used.


Impact of IVDR

Clinicians within the BDL have criticised the IVDR. The new regulation allows less flexibility to quickly develop and conduct laboratory tests at a large scale, when there are few resources for testing.

Especially the pandemic has shown how fast laboratory-developed medicine can be introduced into routine clinical care.

Examples of this are

  • the PCR tests for the SARS-CoV-2 coronavirus,
  • the tracking of known virus mutations and
  • the sequencing of the virus genome.

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