A UK company, Cellpath Limited, has pleaded guilty to three breaches of the Medical Devices Regulations for illegally supplying non-CE marked cutting blades to the UK market. The blades are precision items designed specifi cally for laboratory use on tissue biopsies in the diagnosis of cancer and other pathological states. They are not used directly on people.
There was no CE mark, which determines compliance with European and UK legislation. Products without a CE mark have no assurance that they meet the appropriate standards of safety and performance. The blades were knowingly placed on the UK market without the CE mark of conformity having been affixed.
Cellpath was fined £500 for each charge and was, in addition, ordered to pay £3k court costs and some other expenses.