EU - New MDCG Guidance Documents

The MDCG has published two new guidance documents: MDCG 2024-11 covers the qualification of in vitro diagnostic medical devices. MDCG 2024-12 provides information for Notified Bodies with respect to corrective and preventive action during the joint assessment by authorities. Back in semptember MDCG 2021-4 Rev.1 was published, an update on the application of transitional provisions for certification of class D IVDs .