UK Explains Reporting Requirements for CE-Marked Coronary Stents

Some adverse events involving coronary stents are subject to periodic summary reporting at six-month intervals, according to a new guidance by the UK’s Medicines and Healthcare products Regulatory Agency. Periodic reports should include information about the device and a brief description of the event, including related patient co-morbidity. Interested parties have until Jan. 30 to comment on the guidance.
International Medical Device Regulatory Monitor