UK Court Sentences Defendant in Invalid CE Marking Case: P900 Feeding Pumps Withdrawn from UK and EU Markets After Decade-Long Investigation

Sentencing handed down: suspended prison term, community service and an eight-year directorship ban

On 24 September 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced that Manchester Crown Court had sentenced a 70-year-old defendant on all counts on 23 September 2026.

The sentence is three years' imprisonment, suspended for three years. The defendant must also complete 175 hours of community service and 10 days of rehabilitation activity, and is disqualified from acting as a company director for eight years.

The sentencing date for the co-defendant company, Medicina Limited, has not yet been fixed. The company and the defendant were convicted of multiple offences on 1 July 2026.

An invalid CE marking that lowered hospitals' guard

The case was handled by the MHRA's Devices Compliance function. The first leads emerged in 2013, and the investigation ran for more than a decade.

The devices involved were the P900 enteral feeding pump, a gastrostomy button device and a blunt-ended filling needle. They were supplied bearing an invalid CE marking. Hospitals saw the marking and assumed the products had been assessed against stringent safety standards.

The MHRA put it more directly: before these feeding pumps were placed on the market and entered hospital use, the required assessment, clinical evaluation or safety verification had not been completed. Because the products appeared compliant on their face, a number of NHS hospitals put them into use.

The feeding pumps were used in neonatal intensive care units and special care baby units, to deliver direct gastric feeding to critically ill newborns.

From safety notices to market withdrawal

As the investigation progressed, the MHRA took parallel action: it issued safety notices, oversaw recalls and required the company to stop further supply. The feeding pumps ultimately withdrew from the UK and EU markets.

The September 2026 sentencing is only the final link in that chain. The Crown Prosecution Service has also commenced confiscation proceedings under the Proceeds of Crime Act to recover the proceeds of the offending.

Two baseline requirements for the UK market, restated

In its announcement, the MHRA restated two points:

• All medical devices must comply with the Medical Devices Regulations 2002 and be registered with the MHRA before being placed on the Great Britain market. Placing a device on the market without meeting these requirements is a criminal offence.
• Devices placed on the UK market must bear a valid UKCA or CE marking.

Neither point is a new rule. The case illustrates their weight: an invalid marking is not merely a documentary defect — it can form part of a fraud.

What this means for the supply chain

Buyers have typically checked only whether a certificate exists. This case shows that, beyond existence, the question is whether the certificate is correct: whether the notified body genuinely exists, whether the certificate number can be verified, whether the models covered match the devices actually being supplied, and whether the certificate remains valid. If any one link does not hold, the marking is invalid.

Hospital procurement chains are long, and suppliers change layer after layer. Verification gaps often hide between those layers.

Matters not yet determined

Sentencing for Medicina Limited has not yet been scheduled, and the final amount in the confiscation proceedings has not been published. The facts disclosed in this case are limited to the public statements of the MHRA and the Crown Prosecution Service.

This article draws no conclusions about any other supplier.

Sources and scope of verification

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

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

Verification scope and access date: The full text of both GOV.UK official press releases above was verified, together with the publication sequence on the MHRA organisation news listing page on GOV.UK, on 22 October 2026. The sentencing date, the terms of sentence, the device categories involved, the investigation period, the regulatory measures and the legal basis cited in this article are all taken from these two official releases.

Applicability note: This article is an interpretation of publicly available regulatory and judicial information and does not constitute a conclusion or commitment regarding any specific product, company or registration application. Case facts, sentencing and subsequent proceedings are subject to the official texts and court documents, and information may change with further official updates.

AIMEILI regulatory interpretation

This case is significant less for the sentence itself than for the compliance logic it confirms. The MHRA's position is that a CE or UKCA marking is a claim of conformity that must be traceable to a genuine conformity assessment route. Where the underlying certificate is invalid, the marking is invalid — and supplying the device on that basis is a criminal offence under the Medical Devices Regulations 2002, not a correctable labelling issue.

Key regulatory takeaways

• Marking validity is a legal condition of supply, not a formality. A device must both comply with the 2002 Regulations and be registered with the MHRA before it is placed on the Great Britain market.
• Personal liability is real. In addition to the corporate defendant, an individual officer faced criminal counts and an eight-year disqualification from company directorships.
• Financial recovery follows conviction. Confiscation proceedings under the Proceeds of Crime Act may extend the consequences well beyond the criminal penalty.
• Regulatory action can precede prosecution by years. Safety notices, recall oversight and stop-supply requirements were imposed during the investigation, with market withdrawal occurring before the case concluded.

Verification points for authorisation holders and importers

• Confirm that the notified body named on the certificate exists and is designated for the relevant device type and annex.
• Verify the certificate number in the relevant database and check its current status and expiry date.
• Check that the certificate scope covers the exact models, variants and configurations being supplied.
• Confirm that the manufacturer's declaration of conformity aligns with the certificate and the applicable directive or regulation.
• Retain dated evidence of each verification step in the technical file and supplier qualification records.

Business impact

For manufacturers, importers, distributors and CROs supporting UK or EU market access, the practical consequence is that certificate due diligence must be documented and repeatable, not assumed. Multi-tier supply chains in hospital procurement are precisely where verification gaps accumulate.

• Procurement and supplier qualification: expect buyers and NHS frameworks to require evidence of certificate verification, not just a copy of the certificate.
• Contractual terms: supply agreements should include warranties on certificate validity, scope and status, with notification obligations if a certificate is suspended, withdrawn or expires.
• Change control: any change of notified body, certificate scope or device family should trigger a documented re-verification step before further supply.
• Governance and escalation: senior officers should be able to demonstrate oversight of regulatory claims made on labels and certificates, given the personal liability exposure illustrated here.
• Market access planning: for Great Britain, MHRA registration must be completed before placing a device on the market, in parallel with valid UKCA or CE marking.

Companies relying on legacy certificates or on documentation inherited through acquisitions and supplier transfers should treat this case as a prompt to re-verify the underlying certification chain.

Information sources

• Medicines and Healthcare products Regulatory Agency (MHRA) / GOV.UK, 2026-09-24
• Medicines and Healthcare products Regulatory Agency (MHRA) / GOV.UK, 2026-07-01