The manufacturers of all in vitro diagnostic products for sale in Europe must ensure that their products meet the requirements laid out in the European in vitro Diagnostic Directive (98/79/EC).
For the purpose of affixing a CE mark, the IONA® test has been developed to meet the ‘essential requirements’ specified in Annex I of the Directive and has followed the conformity assessment route of full quality assurance system certification and review of the design dossier by a Notified Body BSI NL, in line with the IONA® test’s classification under Annex II list B of the Directive. The IONA® test received it's CE mark in February 2015. The IONA® Nx NIPT Workflow (IONA® Nx) received it’s CE mark in June 2020.
In addition, the company has a portfolio of CE-marked products in reproductive health and precision medicine that have also been registered to be available for sale in many key interantional markets as in vitro diagnostic devices.