Team-NB has released a document to clarify the concept of “medical device lifetime”. The Medical Devices Regulation (MDR) does not specifically provide a definition for…
MDCG Position Paper on Hybrid Audits
Implemented during the pandemic and helped by new technologies, hybrid audits have become more frequent. A hybrid audit is an audit conducted on site and…
MDCG position paper on Notified Body capacity and availability of medical devices and IVDs!
The Medical Device Coordination Group (MDCG) released a new position paper on the transition to the Medical Devices Regulation (MDR) and In Vitro Devices Regulation (IVDR) this…