MHRA Sentencing in Falsely CE-Marked Medical Device Case: Director Receives Suspended Sentence and Eight-Year Directorship Ban

MHRA Sentencing in Falsely CE-Marked Medical Device Case: Director Receives Suspended Sentence and Eight-Year Directorship Ban

Published: October 1, 2026, 13:32

Category: Registration and Market Access

Sentencing Outcome: Suspended Sentence, Community Service, and Eight-Year Directorship Ban

On September 24, 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced the outcome of a long-running medical device enforcement case. On September 23, 2026, Manchester Crown Court sentenced Kenneth Harrison, aged 70, to three years' imprisonment suspended for three years, together with 175 hours of community service and 10 days of rehabilitation activity, and disqualified him from acting as a company director for eight years. The sentences were imposed for the offences concerned. The sentencing date for the co-defendant, Medicina Limited, has not yet been determined.

Case Background: Invalid CE Marking and Unevaluated Devices

According to case information released by the MHRA and the UK Crown Prosecution Service (CPS), the devices were supplied bearing invalid CE marks, leading healthcare institutions to believe that the products had undergone the necessary safety assessments. The devices involved included enteral feeding pumps, gastrostomy button devices, and blunt fill needles. The enteral feeding pumps were used in neonatal intensive care units and special care baby units to feed seriously ill newborns through gastric tubes. The investigation showed that these pumps were placed on the market without completing the required assessment, clinical evaluation, and safety verification, and entered use in hospitals across the United Kingdom.

Investigation and Regulatory Action

The MHRA's Devices Compliance Unit first identified concerns in 2013 and continued to pursue the matter thereafter. During the investigation, the regulator took a series of patient protection measures, including issuing safety alerts, overseeing recalls, and requiring the company to stop further supply of the devices concerned. The affected enteral feeding pumps were ultimately withdrawn from the UK and EU markets. The CPS also commenced confiscation proceedings under the Proceeds of Crime Act to recover proceeds of crime.

Conviction and Sentencing Timeline

On July 1, 2026, Kenneth Harrison and Medicina Limited were convicted of fraud and of making articles for use in fraud in relation to devices including the P900 enteral feeding pump, gastrostomy button devices, and blunt fill needles. The court initially set Harrison's sentencing date for September 23, 2026, and the MHRA announced the sentencing outcome the following day. The sentencing date for the corporate defendant remains to be determined.

Legal Basis: Marking and Registration Are Two Separate Gateways

In its announcement, the MHRA reiterated that all medical devices placed on the UK market must bear a valid UKCA or CE mark, comply with the requirements of the Medical Devices Regulations 2002, and be registered with the MHRA before being placed on the market in England, Scotland, and Wales. Placing devices on the market without meeting these requirements is a criminal offence. The regulator also reminded stakeholders that suspected non-compliant or counterfeit devices can be reported through official channels, and that adverse events in clinical use should be reported through the Yellow Card system.

Three Points of Reference for Companies

• Marking and registration are independent gateways: Having a mark does not mean registration has been completed, and registration does not replace technical documentation and clinical evaluation.
• Supply-chain roles can be pierced: In this case, the supplier and manufacturer bore criminal liability. A purchasing party's impression that a product 'looks compliant' is not a defence.
• The time span shows that risk does not disappear over time: Products placed on the market more than a decade ago may still be re-examined in subsequent investigations.

Sources and Verification Scope

Source 1: MHRA news release, 'MHRA welcomes sentencing after fraud convictions over falsely certified medical devices,' published September 24, 2026: https://www.gov.uk/government/news/mhra-welcomes-sentencing-after-fraud-convictions-over-falsely-certified-medical-devices

Source 2: MHRA news release, 'MHRA secures convictions after a decade-long investigation into falsely marked baby-feeding devices,' published July 1, 2026: https://www.gov.uk/government/news/mhra-secures-convictions-after-a-decade-long-investigation-into-falsely-marked-baby-feeding-devices

Source 3: GOV.UK guidance, 'Regulating medical devices in the UK': https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk

Verification scope and access date: The three official pages above were accessed on October 1, 2026. The sentencing date, sentence and penalties, device types, regulatory actions, and regulatory requirements in this article are based on the official texts above. Applicability note: This article interprets public enforcement information from UK regulators. It does not constitute legal advice or a conclusion on any specific product, company, or registration application, and it does not make additional comment on the parties to this case. Relevant information may change with subsequent official updates; the official texts should prevail.

Information Sources

• Medicines and Healthcare products Regulatory Agency (MHRA) - GOV.UK news, 2026-09-24
• Medicines and Healthcare products Regulatory Agency (MHRA) - GOV.UK news, 2026-07-01
• GOV.UK - Regulating medical devices in the UK, 2026-02-20

AIMEILI Regulatory Interpretation

This case is a clear UK enforcement signal that the MHRA treats false or invalid CE/UKCA marking, missing clinical evaluation, and absent MHRA registration as criminal compliance failures, not merely administrative defects. For global manufacturers and distributors, the key issue is that a mark alone does not demonstrate market access readiness. UK market access requires both the correct conformity marking route and completion of MHRA registration, supported by technical documentation, clinical evaluation, and safety verification.

For manufacturers, distributors, CROs, and regulatory affairs teams, the practical lesson is that supply-chain due diligence must be evidence-based. A supplier's declaration or a visible CE mark should be verified against the manufacturer's technical file, conformity assessment route, certificate scope, and registration status where applicable. The MHRA's decade-long investigation also shows that historical products can return as enforcement risk when records, clinical evidence, or post-market safety data are incomplete.

Business Impact

Companies placing devices on the UK market should expect greater scrutiny of the link between device marking, registration, technical documentation, and clinical evidence. Distributors and importers may face increased contractual and compliance pressure from hospitals and partners to demonstrate that products are traceable to a valid conformity assessment. Manufacturers with legacy devices, especially those supplied to vulnerable patient groups such as neonates, should review historical files, complaint records, and recall history before any further UK or EU supply.

• Market access risk: Invalid marking or missing MHRA registration can lead to withdrawal, recall, and criminal exposure.
• Supply-chain risk: Distributors and suppliers may be drawn into enforcement even if they relied on manufacturer claims.
• Legacy product risk: Devices placed on the market years ago can still be investigated and challenged.
• Reputational and hospital access risk: NHS trusts and other healthcare providers are likely to tighten verification when safety-critical devices are involved.

Recommended Actions

• Confirm the correct UKCA or CE marking route and ensure the marking is valid for the device and the applicable market.
• Verify MHRA registration before placing devices on the market in England, Scotland, and Wales.
• Maintain technical documentation, clinical evaluation, and safety verification records that can be produced on request.
• Apply risk-based supplier qualification and periodically re-verify certificates, declarations, and registration evidence.
• Maintain robust post-market surveillance, complaint handling, recall procedures, and Yellow Card reporting awareness.
• For legacy or transferred products, perform retrospective gap assessments against current UK requirements and document remediation.

Key Takeaways

• CE/UKCA marking and MHRA registration are separate legal requirements.
• UK market access is a criminal liability issue where patient safety requirements are not met.
• Enforcement risk can persist for more than a decade and can extend across the supply chain.
• Evidence-based due diligence is essential for manufacturers, distributors, and regulatory teams.