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New EU IV Diagnostic Regulation Takes Effect on May 26

While the much-delayed IVDR will take effect at the end of the month, it will be rolled out gradually.

May 26 is D-Day for companies that sell new diagnostics products in Europe. That’s when the much-delayed In Vitro Diagnostic Regulation (IVDR) will take effect. However, the EU will roll it out gradually rather than all in one fell swoop as was originally planned.

The European Commission (EC) and the European Parliament adopted the ((EU) 2017/746) legislative framework for regulation of in vitro medical devices, such as HIV, pregnancy, and SARS-CoV-2 tests in April 2017. That framework consists of two parts:

  1. The new medical devices regulation (MDR); and
  2. The IVDR.

The MDR was originally scheduled to take effect for two years, starting in May 2020, before being replaced by the IVDR in May 2022. Disruption from the global COVID-19 pandemic forced postponement of the MDR; but the EC stubbornly stuck with the May 2022 deadline for the IVDR.

Look for an upcoming news story to learn more about the IVDR requirements.