European Commission Issues Guidance on In Vitro Diagnostic Classification Rules

The European Commission’s Medical Device Coordination Group has published long-awaited guidance that explains 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 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 new guidance offers numerous examples to help manufacturers understand how their IVDs should be classified for compliance with the regulation.