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

The revised MDCG 2022-3 Rev.1 guidance introduces significant updates to the verification process for Class D in vitro diagnostic devices (IVDs) under the In Vitro Diagnostic Regulation (IVDR). Published in December 2024, this document outlines a more structured approach to batch verification by Notified Bodies, ensuring high-risk diagnostic devices meet stringent safety and performance standards. By improving compliance measures and requiring enhanced documentation, the guidance streamlines market access while maintaining rigorous oversight. These updates aim to facilitate the introduction of safer, high-quality diagnostic tools, enhancing patient safety and strengthening the healthcare ecosystem. Manufacturers are encouraged to align with these new requirements for faster and safer market entry.