Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that it has upgraded its European Union (“EU”) regulatory compliance for its diagnostic assay quality assessment products (“QAPs™”). Specifically, Microbix has obtained recognition of its quality management system compliance with the EU In Vitro Diagnostics Regulation (“IVDR”) and Conformité Européenne Certification (“CE Certification”) for an initial portfolio of 11 REDx™ QAPs – two essential regulatory achievements in order for Microbix to have complete access to EU-regulated markets and fully serve its customers.
IVDR came into force in 2022 and greatly increases the burden on makers of diagnostic assays and related medical devices to demonstrate the safety, efficacy, and consistency of their products. While a transition period exists for “Legacy Devices” that entered the EU market prior to 2022, no new regulated products can be sold in the EU unless their makers first achieve IVDR compliance and CE Certification. Accordingly, Microbix has considered it essential to meet these new and challenging regulatory requirements.
Microbix has now achieved its EU Quality Management System Certificate for IVDR and CE Certification for an initial portfolio of 11 of its REDx brand QAPs. This achievement follows the careful evaluation of the products and an audit of Microbix’s systems and facilities – both conducted by a “Notified Body” agency to which the EU has delegated authority for IVDR and CE certifications.
REDx QAPs are used to support the Quality Management System needs of accredited clinical labs running assays that directly drive patient diagnoses and clinical decision-making. In the EU, such clinical labs must adhere to the ISO 15189 quality standards and regularly use IVDR-compliant quality assessment products.
Via these accreditations, Microbix has fully validated its QAPs development processes. CE Certifications can thereby be obtained for (i) QAPs already available in the EU as Legacy Devices, and (ii) newly-created QAPs to be used in clinical settings (i.e., more “REDx” QAPs). Again, Microbix considers IVDR and CE certifications to be essential to support its EU-focused customers and for continuing its sales growth.
Microbix is a technical leader in creating QAPs, which it designs to fully-emulate patient test-specimens while being highly-stable and non-infectious. QAPs are used to train staff, qualify instruments for use, and to assess the extent to which lab quality management system needs are being met. Microbix QAPs support diagnostic assays for infectious diseases across the major categories of gastrointestinal, respiratory, and sexually-transmitted diseases, for assessing cancer risk, and for other uses. QAPs are available as liquid samples, on COPAN® FLOQSwabs®, and as tissue-sample mimetics (i.e., in “FFPE” format).
Microbix’s full catalogue of QAPs is available on its website. Price and order enquiries should be directed to customer.service@microbix.com.
