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Baby Pump Fraud: UK Firm Convicted
2 Jul
Summary
- Medicina Ltd. and Kenneth Harrison convicted of fraud over fake CE marks.
- False CE markings provided false assurance of safety for baby feeding pumps.
- MHRA pursues enforcement to protect patients, especially vulnerable newborns.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has secured convictions against Medicina Limited and its director, Kenneth Harrison, for fraud related to falsely CE-marked baby feeding devices. Investigation found that the Bolton-based company supplied P900 enteral feeding pumps and gastrostomy 'button' devices with invalid CE markings, offering a false assurance of safety to healthcare providers.
These devices were utilized in neonatal intensive care units across NHS Trusts. The MHRA confirmed that the fraudulent devices have since been removed from circulation in the UK and select European markets. Kenneth Harrison is scheduled for sentencing on September 23, 2026, while Medicina's sentencing date is pending.
The UK regulatory landscape for medical devices is evolving. The MHRA has implemented stricter post-market surveillance requirements starting in June 2025. Furthermore, Europe is preparing to launch the European Database on Medical Devices (EUDAMED) by the end of 2028, which aims to centralize medical device registration and monitoring to enhance traceability and combat fraudulent actors.
