The CE Marking of Urine Testing System™ is a significant accomplishment for Clinical Design – allowing the Class 1 Medical Device to be sold to customers in European Union (EU) countries, as well as those countries who recognise the current Medical Device Directive 98/79/EC applicable to In Vitro Diagnostic Devices.
Urine Testing System™ is an integrated digital system that enables semi-automated urine testing at point of care. Designed to improve the efficacy of urine testing, standardised results can be read on the UTS Digital Analyser™ – or on a desktop computer and saved to a patient’s electronic health record.
Royal Devon & Exeter (RD&E) NHS Foundation Trust Pathology Laboratory has supported Clinical Design and extensive testing at the laboratory has provided compliance for all 10 parameters.
Electrical Safety and EMI testing has been independently carried out – and all Risk Assessments confirm the device is safe to use for both patients and users. Clinical Design has recorded an EC Declaration of Conformity.
Clinical Design is now conducting trials of Urine Testing System™ with several general practices in the UK before its full market launch later this year.