Under the Medical Devices Regulation 2017/745 (MDR), it is required for manufacturers to plan, conduct and document a clinical evaluation. As per Article 61(1) MDR,…
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 surveillance data by manufacturers under the new Medical Devices Regulation (MDR)…
IMDRF latest developments: towards global regulatory harmonisation
International Medical Device Regulators Forum (IMDRF) is a group of regulators specialising in the field of medical devices. The IMDRF aims to move forward with…
Legacy devices: new MDCG guidance on NB surveillance & QMS
The Medical Device Coordination Group (MDCG) has published an important guidance establishing the activities to be performed by notified bodies while carrying out their surveillance…