Key Points
- Kenneth George Harrison, 69, of Bolton, and Medicina Limited have been convicted of fraud offences following a long-running investigation by the Medicines and Healthcare products Regulatory Agency (MHRA).
- The investigation found that enteral feeding pumps, gastrostomy “button” devices and blunt fill needles were supplied with invalid CE markings.
- The enteral feeding pumps were used in neonatal intensive care units (NICUs) and special care baby units to feed very sick newborn babies.
- The MHRA said the devices were placed on the market and used in UK hospitals without the required assessments, clinical evaluation or safety testing.
- The regulator first identified concerns in 2013, with the case involving conduct dating back to the period between 2009 and 2014.
- The MHRA issued safety alerts, oversaw recalls and instructed Medicina Limited to stop further supply of the affected devices.
- The affected enteral feeding pumps were subsequently removed from the UK and European Union markets.
- MHRA Executive Director of Innovation and Compliance James Pound said the outcome demonstrated the regulator’s commitment to protecting patients, particularly vulnerable newborn babies.
- Sarah Place, a specialist prosecutor at the Crown Prosecution Service (CPS), said Harrison and Medicina Limited had acted dishonestly and that confiscation proceedings had begun under the Proceeds of Crime Act.
- Medicina Limited has emphasised that the convictions concern historical regulatory certification and related representations, rather than findings that the products themselves were clinically unsafe or caused patient harm.
- Kenneth George Harrison is due to be sentenced on 23 September 2026, while a sentencing date for Medicina Limited has not yet been fixed.
- The case highlights the importance of medical-device regulation, compliance, certification and patient-safety controls in healthcare.
The conviction of Kenneth George Harrison and Medicina Limited follows a decade-long MHRA investigation into the supply of medical devices carrying invalid CE markings and representations concerning their regulatory status. The devices included enteral feeding pumps used to feed vulnerable newborn babies in neonatal intensive care and special care baby units, while the investigation also covered gastrostomy “button” devices and blunt fill needles. The MHRA said the devices had been supplied without the required assessments, clinical evaluation or safety testing, while Medicina Limited has stressed that the convictions relate to historical regulatory certification matters and that there was no finding that patients were harmed.
What happened in the neonatal medical device fraud case?
As reported by MPO Magazine in its report titled “Neonatal Medical Device Firm, Director Convicted in Fraud Case”, the case centres on the conviction of a medical-device company and its former director following an investigation into the supply and regulatory representation of devices used in healthcare.
The MHRA’s official account identifies the individuals and organisation involved as Kenneth George Harrison, aged 69 and from Bolton, and Medicina Limited. Both were found guilty of fraud offences relating to medical devices that were supplied with false or invalid CE markings and representations that healthcare providers said gave an inaccurate impression of their regulatory approval and safety status.
The case is significant because some of the equipment was used in neonatal care. Enteral feeding pumps are used to provide nutrition directly into the stomach of patients who cannot feed normally. According to the MHRA, the affected pumps were used in neonatal intensive care units and special care baby units for very sick newborn babies.The investigation was conducted by the MHRA’s Devices Compliance Unit, which began investigating concerns in 2013 and continued its work for more than a decade before the convictions were secured.
Which medical devices were involved?
The MHRA said the investigation covered several types of medical devices.
These included P900 enteral feeding pumps, gastrostomy button devices and blunt fill needle devices. The regulator said the devices had been supplied with CE markings that were not valid.
CE marking is significant because it indicates that applicable regulatory requirements have been addressed for products placed on relevant markets. In this case, the MHRA said the markings provided a false assurance to healthcare providers that the devices had met the necessary standards.
The investigation found that the affected enteral feeding pumps had been placed on the market and used in hospitals without undergoing the assessments, clinical evaluation or safety testing required under the applicable regulatory framework.
Because the devices appeared to have appropriate regulatory markings, NHS trusts subsequently used them in hospitals across the UK, according to the MHRA.
The regulatory concerns therefore extended beyond paperwork. The case raised questions about the processes used to verify medical-device compliance before equipment reaches healthcare providers and patients.
How long did the MHRA investigation take?
According to the MHRA, the investigation began after concerns were first identified in 2013.
The broader conduct examined in the case dates back further. Medicina Limited said in a statement reported by Healthcare Management that the prosecution arose from an investigation that began in late 2013 and concerned events occurring between 2009 and 2014.
This distinction is important when considering the company’s response. Medicina said the offences related to a period under the ownership and management of former company directors.
The company also said that none of its current owners or directors were involved in, or had knowledge of, the historical matters at the time they occurred.
The MHRA’s investigation nevertheless continued through the subsequent years, eventually resulting in convictions against Harrison and Medicina Limited.
What did the MHRA say about patient safety?
James Pound, MHRA Executive Director of Innovation and Compliance, said the outcome demonstrated that the regulator would take enforcement action when patient safety was at risk.
According to the MHRA, Pound described the investigation as complex and said the Devices Compliance Unit had followed the evidence to ensure that those responsible were held accountable.
Pound also stressed that medical devices must meet strict standards before being used, particularly when they are involved in the treatment of vulnerable patients such as newborn babies.
The MHRA said it had taken measures throughout the investigation to protect patients. Those measures included issuing safety alerts, overseeing recalls and instructing the company to stop supplying the affected devices.
The enteral feeding pumps concerned were ultimately removed from the UK and EU markets, according to the regulator.
What did the Crown Prosecution Service say about the convictions?
The Crown Prosecution Service was also involved in the prosecution.
Sarah Place, a specialist prosecutor at the CPS, said the actions of Harrison and Medicina Limited were dishonest and that the fraudulently labelled products generated substantial profits.
Place also said CPS lawyers had worked closely with the MHRA during the prosecution and would continue pursuing fraud cases.
The CPS has additionally commenced confiscation proceedings under the Proceeds of Crime Act with the aim of recovering funds that may have resulted from the criminal activity.
The confiscation proceedings represent a separate part of the legal process and follow the convictions.
What has Medicina Limited said about the case?
Medicina Limited has provided an important qualification to the regulatory findings.
According to Healthcare Management, the company said the offences related to the historical period when the business was under previous ownership and management. The company stated that its current owners and directors were not involved in, and did not have knowledge of, the historical matters at the time.
Medicina also said the convictions concerned regulatory certification and associated representations, rather than findings about the clinical performance or safety of the products themselves.
The company said there had been no finding that the products were unsafe and no finding that any patient had suffered harm.
That position provides an important distinction in reporting the case. The MHRA’s prosecution concerned fraud, regulatory certification and representations surrounding the devices, while Medicina has disputed any implication that the convictions amounted to a finding of clinical product harm.
The company’s response is particularly relevant because the devices were used in sensitive clinical environments, including neonatal care.
What action did the MHRA take against the devices?
The MHRA said it took action during the investigation to reduce potential risks associated with the devices.
This included safety alerts, recalls and instructions to stop further supply.
The regulator also said the affected enteral feeding pumps were eventually removed from the UK and EU markets.
The actions demonstrate the role of regulatory authorities after concerns about medical devices arise. Rather than waiting for the conclusion of criminal proceedings, the MHRA used regulatory measures during the investigation to address the continued supply and use of affected products.
The case therefore illustrates how criminal enforcement and medical-device regulation can operate alongside each other.
What are the UK’s medical-device regulatory requirements?
The MHRA said all medical devices must comply with the Medical Devices Regulations 2002 and must be registered with the MHRA before being placed on the Great Britain market.
The regulator states that placing devices on the market without meeting these requirements is a criminal offence.
The case involving Harrison and Medicina Limited consequently demonstrates the legal consequences that can arise when regulatory requirements and representations surrounding medical devices are found to be fraudulent.
For manufacturers, suppliers and healthcare organisations, compliance involves more than simply bringing a product to market. Appropriate regulatory assessment, documentation, certification and monitoring form part of the wider framework designed to protect patients.
This is particularly important for devices used in specialist environments such as neonatal intensive care, where patients may be extremely vulnerable.
When will Kenneth George Harrison be sentenced?
Kenneth George Harrison is scheduled to be sentenced on 23 September 2026, according to the MHRA.
A sentencing date for Medicina Limited has not yet been fixed.
The convictions therefore do not represent the end of the legal process. Sentencing and the separate confiscation proceedings remain outstanding.
Medicina’s response also indicates that it does not intend to make further comment while sentencing and subsequent legal processes continue.
The distinction between conviction and sentencing is relevant because the court has established criminal liability, while the penalties and financial consequences are matters for the continuing proceedings.
Why does the case matter for healthcare organisations?
The case highlights the importance of regulatory compliance across the medical-device supply chain.
Hospitals and healthcare providers depend on manufacturers and suppliers to provide accurate information about the status of medical devices. Where certification or regulatory representations are inaccurate, healthcare organisations may face difficulties in determining whether equipment meets the necessary requirements.
The case also demonstrates the particular importance of compliance in neonatal healthcare. Enteral feeding pumps were used in neonatal intensive care and special care baby units, where equipment can play an important role in caring for newborn patients.
For organisations involved in healthcare operations, understanding regulatory obligations, procurement procedures, quality controls and risk management can therefore be important components of responsible management.
This is also relevant to professional development in Healthcare Management, Quality and Productivity, Legal, Contracts and Procurement, and Management, where regulatory oversight, organisational controls and procurement governance intersect with healthcare operations.
What does the case mean for medical-device compliance?
The convictions underline the importance of accurate certification and regulatory representations throughout the lifecycle of a medical device.
The MHRA’s findings show that concerns can remain under investigation for years, particularly where historical conduct requires extensive examination. The regulator’s Devices Compliance Unit first identified concerns in 2013 and continued investigating until the case reached its conclusion.
The case also illustrates why healthcare organisations need robust processes for checking suppliers, documentation and regulatory status.
For professionals working across Healthcare Management, Legal, Contracts and Procurement,Quality and Productivity, and Safety and Security, the case provides a practical example of how regulatory compliance, supplier governance and patient protection can intersect.
The broader lesson is that medical-device regulation is not simply an administrative requirement. Accurate certification and compliance information can affect procurement decisions, hospital use and ultimately the protection of patients.
What happens next in the Medicina case?
The immediate next stage is the sentencing of Kenneth George Harrison, scheduled for 23 September 2026.
Medicina Limited’s sentencing date remains outstanding, while confiscation proceedings under the Proceeds of Crime Act are also under way, according to the MHRA. The case will therefore continue to have legal and regulatory implications beyond the convictions announced in July.
The MHRA has also reiterated that medical-device incidents can be reported through its Yellow Card scheme. The regulator remains responsible for overseeing medicines and medical devices in Great Britain and for taking enforcement action where required.
For organisations operating in healthcare and related sectors, the case reinforces the need for strong compliance practices, transparent procurement and appropriate regulatory oversight. Training and professional development in Healthcare Management, Legal, Contracts and Procurement, and Quality and Productivity can provide relevant knowledge for professionals dealing with these organisational responsibilities.