Under the Medical Devices Regulation 2017/745 (MDR), it is required for manufacturers to plan, conduct…
PSUR under MDR: When it’s necessary, and what are the deadlines?
As part of the efforts to establish a more consistent and systematic review of post-market…
IMDRF latest developments: towards global regulatory harmonisation
International Medical Device Regulators Forum (IMDRF) is a group of regulators specialising in the field…
Legacy devices: new MDCG guidance on NB surveillance & QMS
The Medical Device Coordination Group (MDCG) has published an important guidance establishing the activities to…