European Commission Clarifies In Vitro Diagnostic Classification Rules

The European Commission’s Medical Device Coordination Group has released long-awaited guidance on how to classify products for compliance with the European Union’s In Vitro Diagnostic Regulation (EU IVDR).

The IVDR is replacing the EU’s list-based classification system with a more flexible, risk-based system, which will require the reclassification of many IVDs.

The new guidance offers numerous examples to help manufacturers understand how their IVDs should be classified. For example, a device intended to screen blood and tissue donations for syphilis would fall under Class D — meaning that it poses a high individual risk and a high risk to public health — while a device intended to diagnose syphilis would be classified under Class C, indicating that it poses a high individual risk and/or a medium risk for public health.

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.