The UK Medicines and Healthcare products Regulatory Agency (MHRA) has secured convictions in a long-running case around falsely CE-marked baby feeding devices.
Led by the agency’s Devices Compliance unit, the investigation found UK-based Medicina Limited and its company director, Kenneth Harrison, guilty on a string of fraud offences after supplying medical devices with false CE markings to healthcare providers including National Health Service (NHS) Trusts across the UK.
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Initiated after concerns were identified in 2013, the investigation found that a number of devices, including the Bolton-based company’s P900 enteral feeding pumps and gastrostomy ‘button’ devices were supplied with CE markings that were not valid, giving a “false assurance to healthcare providers” that these devices met strict safety standards, the MHRA stated.
In the UK, devices must be registered with the MHRA, hold a valid UK CE or UKNI mark in Northern Ireland, and comply with the UK Medical Device Regulations 2002 (UK MDR) to be legally marketed.
Medicina’s enteral feeding pumps were used in neonatal intensive care units and special care baby units to feed critically ill newborn babies directly into their stomachs. Since the devices appeared compliant, NHS trusts had put them into use at hospitals across the country. The devices have since been removed from circulation in the UK and select European markets.
James Pound, executive director for innovation and compliance at the MHRA, said: “This outcome sends a clear message that the MHRA will not hold back when patient safety is at risk.
“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.”
For his role in the fraud case, Kenneth Harrison is due to be sentenced on 23 September 2026, while a sentencing date for Medicina is yet to be determined.
Sarah Place, specialist prosecutor from the Crown Prosecution Service (CPS) , commented: “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.”
Fraudulent medical device identification poised for shift
Unlike for counterfeit or falsified pharmaceuticals that are chiefly governed by the EU’s Falsified Medicines Directive (FMD), there currently exists no comparable mechanism towards the monitoring and prevention of counterfeit medical devices in Europe.
In the UK, one of the closest mechanisms is the Yellow Card scheme, enabling healthcare providers to report safety concerns about medical devices. Meanwhile, the MHRA has begun to overhaul some of its medical device regulation. In June 2025, the agency launched stricter post-market surveillance requirements for product manufactures.
In Europe, a more stringent initiative, comparable to the FMD, for dealing with fraudulent medical devices, is primed for implementation.
In conjunction with the EU MDR and In Vitro Diagnostic Regulation (IVDR), for which a full implementation is being targeted by the end of 2028, the European Commission (EC) is rolling out the European Database on Medical Devices (EUDAMED).
Developed by the EC to track and monitor medical devices across Europe, the database will centralise the registration, tracking, and regulation of medical devices, with a view to improving device traceability and compliance end-to-end; thereby rooting out fraudulent actors by virtue of its structure and mandates.
