Kenneth Harrison: MHRA Medical Device Fraud Sentencing Leads to Suspended Term

• Kenneth George Harrison received a three-year suspended prison sentence, community service, rehabilitation, and an eight-year director disqualification for medical device fraud.
• Harrison and Medicina Limited were found guilty of supplying medical devices, including enteral feeding pumps used for infants, with invalid CE markings.
• The MHRA's decade-long investigation uncovered the fraudulent scheme, which falsely assured healthcare providers of device safety.
• Confiscation proceedings under the Proceeds of Crime Act have been initiated to recover funds from the criminal activity.
• All medical devices in the UK must carry a valid UKCA or CE mark, signifying compliance with essential safety standards.

The Medicines and Healthcare products Regulatory Agency has demonstrated its commitment to robust enforcement against individuals and companies that attempt to bypass essential regulations designed to protect patient safety.

Kenneth George Harrison, a 70-year-old individual from Bolton, has received a suspended prison sentence following his conviction for medical device fraud. At Manchester Crown Court on September 23, 2026, Harrison was handed a three-year prison term, which was suspended for three years, with this sentence running concurrently across all counts. This outcome concludes a significant enforcement investigation that spanned more than a decade.

In addition to the suspended sentence, the court mandated Harrison to complete 175 hours of community service and undertake 10 days of rehabilitation. Further punitive measures include an eight-year disqualification from serving as a company director. These penalties follow convictions announced in July 2026, stemming from a complex and prolonged inquiry into the illegal supply of medical devices across the United Kingdom.

The fraudulent scheme involved the supply of various medical devices, including P900 enteral feeding pumps, gastrostomy button devices, and blunt fill needles, which were marketed with invalid CE markings. This practice provided healthcare providers with false assurances regarding the safety and compliance of these products with necessary standards. The investigation, spearheaded by the Medicines and Healthcare products Regulatory Agency's (MHRA) Devices Compliance Unit, first identified concerns in 2013 and diligently pursued the case for over ten years.

On July 1, 2026, Kenneth George Harrison and Medicina Limited were found guilty of fraud offences related to these devices. Of particular concern were the enteral feeding pumps, which were utilized in highly sensitive environments such as neonatal intensive care units (NICUs) and special care baby units (SCBUs) for feeding critically ill newborn babies directly into their stomachs. The MHRA took proactive steps throughout the investigation to safeguard patients, including issuing safety alerts, overseeing product recalls, and instructing the company to cease further supply of the non-compliant devices. Ultimately, the affected enteral feeding pumps were removed from both the UK and EU markets.

The case highlights the critical importance of regulatory compliance within the medical device sector. All medical devices introduced to the UK market are legally required to possess a valid UKCA or CE mark, which serves as a vital indicator that the products meet stringent safety and performance standards. The Medicines and Healthcare products Regulatory Agency, as the primary body responsible for regulating all medicines and medical devices in the UK, plays a crucial role in ensuring these products are both effective and acceptably safe for public use.

The MHRA's robust enforcement against this fraudulent activity underscores its commitment to maintaining the integrity of the medical device supply chain. Healthcare professionals rely on these certifications to trust that the equipment they use has been properly assessed and adheres to the standards designed to protect patient well-being. The agency's thorough and fact-based judgments are fundamental to ensuring that the benefits of medical devices consistently outweigh any potential risks.

This sentencing sends a clear message about the MHRA's dedication to taking decisive action against those who attempt to circumvent regulations designed to keep patients safe. The agency's long-running investigation, conducted in close collaboration with the Crown Prosecution Service, demonstrates a sustained effort to bring perpetrators of medical device fraud to justice. The actions of Harrison and Medicina Limited were characterized as completely dishonest, generating substantial sales from their fraudulently labeled products.

Further legal proceedings are underway, with confiscation proceedings initiated under the Proceeds of Crime Act. This measure aims to recover any available funds derived from the criminal activity, reinforcing the financial repercussions for such offenses. While Kenneth George Harrison's sentencing has concluded, a date for Medicina Limited's sentencing is yet to be determined, indicating the ongoing legal consequences for the corporate entity involved in the medical device fraud.

This case underscores the MHRA's robust enforcement against medical device fraud and non-compliance with certification standards. Lawyers advising medical device manufacturers, distributors, or healthcare providers must ensure strict adherence to UKCA/CE marking requirements to mitigate severe penalties, including director disqualification and asset forfeiture under the Proceeds of Crime Act, and to protect against the supply of unsafe products.

Source: Original reporting via GOV.UK