A key moment in the compliance process of products is their classification. It is the…
Updated MDCG Guidance on classification rules for IVD medical devices
In February 2023, the Medical Device Coordination Group (MDCG) published a new revision of the…
MDR & IVDR: Manual on borderline classification issued!
In September 2022, the Medical Devices Coordination Group (MDCG) issued a manual addressing borderline and…