The Medicines and Healthcare products Regulatory Agency (MHRA) has today secured convictions following a long running investigation led by its Devices Compliance Unit into the illegal supply of medical devices used in hospitals across the UK.
Kenneth George Harrison 69 of Bolton and Medicina Limited were found guilty of a number of fraud offences after supplying medical devices with false CE markings and misleading healthcare providers about their safety and regulatory approval.
This case is the result of years of detailed investigative work by the MHRA, which first identified concerns in 2013 and continued to pursue the case to its end.
The investigation found that a number of devices, including enteral feeding pumps, gastrostomy “button” devices and blunt fill needles, were supplied with CE markings that were not valid, giving a false assurance to healthcare providers that the devices met strict safety standards.
Enteral feeding pumps were used in neonatal intensive care units and special care baby units to feed very sick newborn babies directly into their stomachs.
The investigation discovered that these pumps were placed on the market and used in hospitals without undergoing the required assessments, clinical evaluation or safety testing. Due to the devices appearing compliant, NHS trusts had put them into use at hospitals across the UK.
Throughout the investigation, the MHRA took action to protect patients, including issuing safety alerts, overseeing recalls and instructing the company to stop further supply of the devices. The affected enteral feeding pumps were ultimately removed from the UK and EU markets.
James Pound, MHRA Executive Director Innovation and Compliance, said
“This outcome sends a clear message that the MHRA will not hold back when patient safety is at risk.
“This has been a complex investigation led by our Devices Compliance Unit, who were dedicated to following the evidence to ensure those responsible were held to account.
“Medical devices must meet strict standards before they can be used, especially when caring for the most vulnerable patients, including newborn babies.
“The MHRA will continue to take robust enforcement action to protect patients throughout the UK.”
Sarah Place, specialist prosecutor from the Crown Prosecution Service said
“The actions of Harrison and Medicina Limited were completely dishonest and from their fraudulently labelled products, they turned a substantial profit.
“CPS lawyers worked closely with the MHRA to prosecute this case, and we will continue to bring those who commit fraud to justice.
“We have also commenced confiscation proceedings under the Proceeds of Crime Act to recover any available funds from this criminal activity.”
All medical devices must comply with the Medical Devices Regulations 2002 and need to be registered with the MHRA before they are placed on the Great Britain market. Placing devices on the market without meeting these requirements is a criminal offence.
Anyone who experiences an adverse incident involving a medical device should report it directly to the MHRA Yellow Card scheme.
Notes to editors
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Kenneth George Harrison and Medicina Ltd have been convicted of fraud on all counts relating to P900 enteral feeding pumps, Gastrostomy Button device, Blunt Fill Needle devices, and making an article for use in Fraud.
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Sentencing for Kenneth George Harrison has been set for 23 September 2026. A date is yet to be fixed for Medicina Ltd sentencing.
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For more information on Gastrostomy care and feeding devices, see here Gastrostomy care Great Ormond Street Hospital
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More information on how to report non-compliant medical devices is available here Report a non-compliant or suspected counterfeit medical device – GOV.UK
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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