In February 2023, the Medical Device Coordination Group (MDCG) published a new revision of the Guidance on classification rules for IVD medical devices. The revision…
MDR & IVDR: Manual on borderline classification issued!
In September 2022, the Medical Devices Coordination Group (MDCG) issued a manual addressing borderline and classification under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic…