The European Commission has released the updated document on the ongoing work of the MDCG…
First MDCG Guidance documents on Annex XVI products
In December 2023, the Medical Device Coordination Group (MDCG) published for the first time two…
Classification of medical devices: Which legal provisions and guides to consider?
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…