01 / EXECUTIVE SUMMARY
The MHRA secured fraud convictions relating to medical devices supplied with false CE markings; enteral feeding pumps were used in neonatal and special-care baby units without required assessment, clinical evaluation or safety testing.
02 / WHAT HAPPENED
The MHRA secured fraud convictions relating to medical devices supplied with false CE markings; enteral feeding pumps were used in neonatal and special-care baby units without required assessment, clinical evaluation or safety testing.
The chain distinguishes what appeared valid, what was physically true, which authority followed and what consequence the source documents.
CE markings and supplier representations claimed the devices had valid regulatory approval and met safety requirements.
The MHRA found the markings invalid and the pumps had not undergone required assessments, clinical evaluation or safety testing.
NHS trusts placed the devices into use in hospitals, including neonatal intensive-care and special-care baby units.
The devices were recalled and removed from UK and EU markets; the release does not quantify patient injuries.
Regulator-verifiable binding among approval record, manufacturer, model and each physical device before clinical use.
ECR separates a documented monetary floor from a modeled social and economic consequence envelope. It is not an accounting loss figure.
Public evidence does not disclose a monetary amount or affected population; the range is therefore prior-led and deliberately wide.
Convictions, device use and regulatory failures are MHRA facts. The Presence Risk interpretation is 4SI analysis.
A conformity mark can carry authority while the physical product behind it remains unverified.
4SI does not claim to have independently verified the underlying event. Scores, boundary analysis and economic ranges interpret published evidence; they are not probabilities, compliance findings, valuations or loss forecasts.
Related cases are editorially connected by domain, authority pattern or missing physical trust boundary.