In October 2024, the MDCG published two documents: one on the regulatory status of ethylene oxide (EtO) used for the sterilisation of medical devices, and…
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 manufacturer’s sole responsibility to select the appropriate class and rule…
MDR & IVDR: Update to Manual on borderline classification!
The Medical Devices Coordination Group (MDCG) released in December 2022 a new update to their manual on borderline and classification for medical devices under MDR…
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…