Director Sentenced Over Fake CE-Marked Baby Devices

A decade-long MHRA investigation into medical devices used to feed critically ill newborns ended in a courtroom in Manchester on 23 September 2026, when Kenneth George Harrison was sentenced for supplying enteral feeding pumps, gastrostomy button devices and blunt fill needles bearing CE markings that were not valid — false assurances, to the hospitals that bought them, that the products had cleared the EU-wide safety and conformity checks the mark is supposed to certify.

What the CE mark was supposed to guarantee

A valid CE mark on a medical device tells a buyer — a hospital procurement office, a clinician, ultimately a patient's family — that the device has been through a conformity assessment against EU safety and performance requirements, whether self-certified for lower-risk products or checked by an independent notified body for higher-risk ones. According to the MHRA, Harrison co-founded Medicina Ltd in 1991 as a legitimate supplier of medical goods, but came to treat proper testing and certification as, in the regulator's account of the case, mere “red tape” and an inconvenience. What followed was the sale of devices carrying CE marks the company had not validly earned, to buyers who had no way of knowing the assurance behind the mark was hollow.

Why the enteral feeding pumps matter most

Of the products named in the case, the enteral feeding pumps carry the sharpest edge: they were used in neonatal intensive care units and special care baby units to deliver feeds directly into the stomachs of very sick newborns, patients who cannot advocate for themselves and whose clinicians are relying entirely on the device performing exactly as its documentation says it does. Gastrostomy button devices and blunt fill needles, also named in the conviction, serve related feeding and delivery functions in vulnerable patients. The MHRA has not stated that a specific patient was harmed by a device failure tied to this case, and this piece does not assert one; the fraud proven at trial was in the certification, not, per the public record so far, in a documented clinical incident.

A decade to get here

The MHRA's Devices Compliance Unit first flagged concerns about Medicina Ltd's products in 2013. The case did not reach conviction until 1 July 2026, and sentencing followed nearly three months after that, on 23 September — a timeline the regulator's own announcement frames as evidence of persistence rather than delay, noting the complexity of tracing device history and CE certification claims across more than a decade of sales. James Pound, MHRA's executive director for innovation and compliance, said the outcome “sends a clear message that the MHRA will not hold back when patient safety is at risk,” adding that “medical devices must meet strict standards before they can be used, especially when caring for the most vulnerable patients, including newborn babies,” and that the agency “will continue to take robust enforcement action to protect patients throughout the UK.” Medicina Ltd's own sentencing has not yet been scheduled.

What it means for device compliance teams

The case predates both the EU's transition from the Medical Device Directive to the Medical Device Regulation and the UK's post-Brexit UKCA marking framework, but its lesson is not time-bound: a CE (or UKCA) mark is a claim a manufacturer makes about its own conformity assessment, and a buyer's confidence in that claim is only as good as the enforcement record standing behind it. For hospital procurement and quality teams, the case is a reminder that supplier due diligence on certification claims — not just on a device's stated specifications — remains a live risk, particularly for devices sourced from smaller suppliers outside the major manufacturers' direct channels.

Frequently asked questions

Who was sentenced, and for what?

Kenneth George Harrison, co-founder of Medicina Ltd, was convicted on 1 July 2026 of fraud and making an article for use in fraud, over enteral feeding pumps, gastrostomy button devices and blunt fill needles sold with CE markings the products did not validly hold.

What was his sentence?

A three-year prison sentence suspended for three years, 175 hours of unpaid community work, 10 days of a rehabilitation activity, and an eight-year company director disqualification. Medicina Ltd's own sentencing date has not been fixed.

Who used the affected devices?

The enteral feeding pumps were used in neonatal intensive care units and special care baby units to feed critically ill newborns. The devices were sold to hospitals and clinics in the UK and internationally.

How long did the investigation take?

The MHRA's Devices Compliance Unit opened its investigation in 2013 over conduct dating to 2009–2014, and pursued the case for more than a decade before securing convictions in July 2026.