Significant Sentencing in Medical Device Fraud Case
The Medicines and Healthcare products Regulatory Agency (MHRA) has expressed its approval of the sentencing of Kenneth George Harrison, following an extensive investigation into the illicit distribution of medical devices utilised in hospitals throughout the United Kingdom.
At Manchester Crown Court on 23 September 2026, Kenneth George Harrison, aged 70 from Bolton, was handed a concurrent sentence for multiple offences, resulting in a three-year prison term, which has been suspended for three years. Additionally, he has been mandated to complete 175 hours of community service, undertake 10 days of rehabilitation, and is disqualified from serving as a company director for the next eight years.
Decade-Long Investigation Reveals Serious Breaches
The convictions, which were made public in July, stem from a complex investigation led by the MHRA’s Devices Compliance Unit, which began identifying concerns back in 2013 and pursued the case for over a decade.
The investigation uncovered that a variety of medical devices, including enteral feeding pumps, gastrostomy button devices, and blunt fill needles, were supplied with invalid CE markings. This misled healthcare providers into believing that these devices adhered to the necessary safety standards.
Commitment to Patient Safety Highlighted by MHRA
James Pound, Executive Director of Innovation and Compliance at the MHRA, remarked on the conclusion of the protracted investigation, stating, “This has been a long and complex inquiry, and today’s sentencing reinforces our dedication to enforcing regulations that safeguard patient health.”
Pound emphasised the importance of trust in the healthcare sector, asserting that professionals must have confidence that the medical devices they utilise have undergone thorough evaluation and comply with established safety standards.
He extended gratitude to the MHRA investigators for their unwavering commitment over the years and acknowledged the collaboration with the Crown Prosecution Service in bringing the case to trial.
Close Cooperation Between Agencies in Pursuit of Justice
Sarah Place, a specialist prosecutor from the Crown Prosecution Service, denounced Harrison and Medicina Limited’s actions as wholly dishonest, noting that they profited significantly from their fraudulently marketed products.
Place highlighted the close partnership between CPS lawyers and the MHRA in prosecuting this case, reaffirming the commitment to pursuing justice against those who engage in fraudulent activities. Furthermore, she indicated that confiscation proceedings had commenced under the Proceeds of Crime Act, aiming to recover any funds arising from this criminal conduct.
Proactive Measures to Ensure Patient Safety
Throughout this investigation, the MHRA acted decisively to protect patients, issuing safety alerts, managing product recalls, and instructing the company to halt the supply of the affected devices.
The enteral feeding pumps in question were employed in neonatal intensive care units and special care baby units, providing essential nutrition to critically ill newborns. Ultimately, the compromised enteral feeding pumps were withdrawn from the UK and EU markets.
Overview of Regulatory Standards for Medical Devices
On 1 July 2026, both Kenneth George Harrison and Medicina Limited were found guilty of fraud related to P900 enteral feeding pumps, gastrostomy button devices, and blunt fill needle devices. A sentencing date for Medicina Ltd is yet to be scheduled.
All medical devices available on the UK market must possess a valid UKCA or CE mark. For further information regarding the regulation of medical devices in the UK, additional resources are available.
The MHRA is tasked with regulating all medicines and medical devices in the UK, ensuring their efficacy and safety. Their operations are underpinned by rigorous and evidence-based evaluations to guarantee that the benefits of these products outweigh any associated risks.
As an executive agency of the Department of Health and Social Care (DHSC), the MHRA continues to play a vital role in maintaining public health standards.
For media inquiries, please reach out to newscentre@mhra.gov.uk or call 020 3080 7651.