MDCG 2022-3 rev.1 - Verification of manufactured class D IVDs by notified bodies

The European Commission has officially released the revised MDCG 2022-3 Rev.1 guidance, which introduces critical changes to the verification process for Class D in vitro diagnostic devices (IVDs). This updated guidance, published in December 2024, is aimed at improving the conformity assessment and market access procedures for high-risk diagnostic devices under the In Vitro Diagnostic Regulation (IVDR).

One of the key changes outlined in this update is the clearer and more structured process for batch verification by Notified Bodies. This revision ensures that these devices undergo rigorous scrutiny before they are approved for the European market, enhancing the safety and reliability of diagnostic devices used in healthcare settings. The update also emphasizes the need for manufacturers to provide more detailed documentation and evidence to support the safety and performance of these high-risk devices.

The guidance strengthens the regulatory framework for high-risk IVDs by introducing stricter compliance measures, particularly for devices that play a pivotal role in diagnosing critical conditions. Manufacturers will now be required to follow more stringent processes to demonstrate compliance, ensuring that only those devices that meet the highest standards of quality and safety are allowed in the market.

With these updates, the European Union aims to streamline the process of market access for high-risk IVDs while maintaining rigorous oversight. These changes are expected to lead to faster and safer market access for critical diagnostic tools, ultimately enhancing patient safety and the overall healthcare ecosystem. Manufacturers are urged to carefully review the guidance to ensure they are fully aligned with the new regulatory requirements.