Suspended sentence for Bolton man convicted of fraud over falsely CE-marked baby-feeding devices
Kenneth George Harrison, aged 70, of Bolton, received a three-year prison sentence suspended for three years at Manchester Crown Court on 23 September 2026, after he and Medicina Limited were convicted of fraud over medical devices supplied with invalid CE marking. The MHRA first identified concerns in 2013. As of the MHRA's 24 September announcement, Medicina Limited had not yet been sentenced.
The sentence
According to the MHRA, Harrison received a concurrent sentence on all counts: three years' imprisonment suspended for three years, 175 hours of community service, 10 days of rehabilitation, and disqualification from acting as a company director for eight years. A date has yet to be fixed for sentencing Medicina Limited.
Harrison and Medicina Limited were found guilty on 1 July 2026 of fraud offences relating to P900 enteral feeding pumps, gastrostomy button devices and blunt fill needles. The MHRA's July announcement also lists "making an article for use in Fraud" among the convictions; its September announcement does not repeat it.
Feeding pumps used on sick newborns
The MHRA says the devices were supplied with CE marking that was not valid, "giving healthcare providers false assurances that the devices met the necessary safety standards." The enteral feeding pumps were used in neonatal intensive care and special care baby units to feed very sick newborns directly into their stomachs. According to the MHRA's July announcement, its investigation found the pumps were placed on the market and used in hospitals "without undergoing the required assessments, clinical evaluation or safety testing," and NHS trusts put them into use because they appeared compliant.
The MHRA says that during the investigation it issued safety alerts, oversaw recalls and told the company to stop supplying the devices, and that the pumps were eventually removed from the UK and EU markets.
More than a decade from concern to sentence
The case was led by the MHRA's Devices Compliance Unit, which first identified concerns in 2013, some 13 years before sentencing. The Crown Prosecution Service said it has begun confiscation proceedings under the Proceeds of Crime Act. In the MHRA's September announcement, CPS specialist prosecutor Sarah Place said Harrison and Medicina "made substantial sales from their fraudulently labelled products."
James Pound, the MHRA's Executive Director of Innovation and Compliance, said: "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."
What buyers can check
A CE mark is the manufacturer's declaration that a device meets the applicable requirements, and for some devices it can be self-certified. It is not in itself proof. The MHRA says the marks in this case were not valid, and that because the devices appeared compliant, NHS trusts put them into use.
The MHRA says all medical devices placed on the UK market must hold a valid UKCA or CE mark, and that devices must be registered with the MHRA before they are placed on the Great Britain market. Requirements differ in Northern Ireland. The MHRA's Public Access Registration Database (PARD) lists registered manufacturers' names, addresses and device types, but MHRA guidance says registration "does not represent any form of accreditation, certification, approval or endorsement", so a PARD entry does not show a device is compliant. Where a device's certificate names a notified body, buyers can check that the body is listed in the European Commission's NANDO database for the relevant legislation.
Anyone who believes a non-compliant device is on sale in the UK can report it to the MHRA at devices.compliance@mhra.gov.uk. Suspected counterfeits can also be reported through the Yellow Card scheme.
Frequently asked questions
What sentence did Kenneth Harrison receive?
Three years' imprisonment suspended for three years, 175 hours of community service, 10 days of rehabilitation and an eight-year disqualification from acting as a company director, at Manchester Crown Court on 23 September 2026.
Which devices were involved?
P900 enteral feeding pumps, gastrostomy button devices and blunt fill needles, supplied with CE marking that was not valid.
Has Medicina Limited been sentenced?
Not as of the MHRA's 24 September announcement, which said a date was yet to be fixed.
How do I report a suspected non-compliant device in the UK?
Email the MHRA at devices.compliance@mhra.gov.uk. Suspected counterfeits can also be reported through the Yellow Card scheme.
- MHRA, MHRA welcomes sentencing after fraud convictions over falsely certified medical devices, 24 September 2026
- MHRA, MHRA secures convictions after a decade-long investigation into falsely marked baby-feeding devices, 1 July 2026
- MHRA, Report a non-compliant or suspected counterfeit medical device
- MHRA, Register medical devices to place on the market
- European Commission, notified bodies database (NANDO)