The IONA® test is a CE-marked in vitro diagnostic product which meets the requirements laid out in the European In Vitro Diagnostic Directive (98/79/EC). The IONA® test system meets the stringent regulatory requirement for a non-invasive screening test and has been externally reviewed by a Notified Body. This is substantially more rigorous than a self-certification CE mark, in line with the IONA® test’s classification under Annex II list B of the Directive. In addition, the IONA® Software for analysis has been built to stringent quality standards and has been developed with BS EN 62304 compliance. The IONA® test received its CE mark in February 2015. This ensures a high-quality robust, reproducible screening test with verification and clinical validation already performed to enable fast implementation with confidence.