MedTech Europe: High-Risk Diagnostics Vulnerable in Shift to New In Vitro Device Regulations

November 24, 2020

MedTech Europe said the implementation of the EU’s In Vitro Medical Device Regulation (IVDR) “has ground to a halt” due to the pandemic and the industry group is pressing the European Commission for assistance during the transition for high-risk diagnostic devices.

The high-risk Class D diagnostics are particularly vulnerable during the transition period because they need to complete their IVDR certification before May 26, 2022, as they don’t qualify for a grace implementation period for the IVDR that extends to May 27, 2024, the industry group said.

“Of serious concern is the fact that around 18 months away from IVDR date of application, the specific Class D conformity assessment infrastructure is limited or missing altogether,” MedTech Europe said.

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