Kenneth George Harrison, aged 70, of Bolton, received a three-year prison sentence suspended for three years at Manchester Crown Court on 23 September 2026, after he and Medicina Limited were convicted of fraud over medical devices supplied with invalid CE marking. The MHRA first identified concerns in 2013. As of the MHRA's 24 September announcement, Medicina Limited had not yet been sentenced.
The MHRA's device safety information DSI/2026/012, issued on 17 September 2026, warns that wireless cardiotocography (CTG) monitors sharing a radio channel can, in rare circumstances, display the fetal heart rate picked up by another monitor. It also flags erroneous traces and signal dropouts, and applies to classic telemetry systems in the ISM radio band. Alongside clinical checks, it puts duties on procurement: trusts should assess the radio environment and channel availability before buying, and keep a register of every wireless CTG device and the channel it uses.
The MHRA has published draft Medical Devices (Amendment) Regulations 2026, reforming pre-market requirements for Great Britain. The headline is an international reliance pathway allowing devices already authorised in the United States, Canada or Australia to reach the GB market without repeating a full GB conformity assessment. The regulations and the pathway arrive on different timetables: the amendment is expected to come into force in 2027, the reliance pathway itself in 2028.