The new regulation goes into effect on May 26, 2022, except for in vitro diagnostics that qualify for a grace implementation period that extends to May 27, 2024.

The applications should include a risk assessment and the results of electromagnetic compatibility testing, the agency 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.