MHRA responds to sentencing over falsely certified devices

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The Medicines and Healthcare products Regulatory Agency (MHRA) has welcomed the sentencing of Medicina Ltd co-founder Kenneth Harrison, following an investigation into the illegal supply of medical devices to hospitals across the UK.

Harrison’s convictions, announced in July 2026, followed an investigation by the MHRA’s Device Compliance Unit, which began after concerns were first raised in 2013. The investigation found that several products – including enteral feeding pumps, gastrostomy button devices and blunt fill needles – had been supplied with invalid CE marking. This gave healthcare providers misleading assurance that the devices passed EU-wide safety and regulatory approval.

At Manchester Crown Court on September 23, 2026, Harrison received a three-year sentence, with concurrent sentences imposed across all counts. Judge Timothy Smith also ordered Harrison to complete 175 hours of unpaid work and 10 days of rehabilitation activity. He has been disqualified from acting as a company director.
A sentencing date for Medicina Ltd has yet to be set. According to BBC News, Harrison is understood to have left the company.

James Pound, MHRA executive director of Innovation and Compliance, commented, “This has been a long and complex investigation, and we’re glad to have a conclusion with this sentencing. It demonstrates our commitment to taking robust enforcement action against those who try to bypass regulations that help keep patients safe. Healthcare professionals need to be able to trust that the medical devices they use have been properly assessed and meet the standards designed to protect patients.  I want to thank our MHRA investigators for their dedication and persistence over many years, as well as our partners at the Crown Prosecution Service for helping bring this case to court.”

Sarah Palace, specialist prosecutor from the Crown Prosecution Service (CPS), said, “The actions of Harrison and Medicina Limited were completely dishonest and they made substantial sales from their fraudulently labelled products. 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.”