Life sciences manufacturer Microbix Biosystem has announced upgrades to its European Union (EU) regulatory compliance for its diagnostic assay quality assessment products (QAPs).
The company has obtained recognition for its quality management system in line with the EU In Vitro Diagnostics Regulation (IVDR) and has received Conformité Européenne Certification (CE Certification) for an initial 11 REDx QAPs portfolio.
These regulatory achievements are crucial for Microbix to gain full access to markets regulated by the EU and to serve its customers completely.
The EU Quality Management System Certificate for IVDR and CE Certification for the QAPs follows a thorough evaluation of the products and an audit of the company’s facilities and systems.
This audit was carried out by a notified body agency, which holds delegated authority from the EU for IVDR and CE certifications.
The QAPs are instrumental in supporting the quality management system needs of clinical labs that are accredited and conduct assays directly impacting patient diagnoses and clinical decision-making.
In the EU, these labs are required to comply with ISO 15189 quality standards and should regularly use quality assessment products that are compliant with IVDR.
Through these accreditations, Microbix has validated its development processes, enabling it to obtain CE Certifications for both existing QAPs in the EU, known as Legacy Devices, and for new products intended for clinical use.
In December 2023, molecular assay provider Seegene USA entered a collaboration with Microbix Biosystems for the QAPs.
Microbix creates QAPs that closely mimic patient test specimens while being stable and non-infectious.
They are utilised for training staff, qualifying instruments, and assessing lab quality management system needs.
The products support diagnostic assays for infectious diseases, cancer risk assessment, and other applications. They are available in various formats, including tissue-sample mimetics in FFPE format and liquid samples, on COPAN FLOQSwabs.
