The Company’s quality management system has been assessed and approved as applicable to the design, development and manufacture of in vitro diagnostic reagents and associated software for non-invasive assessment of genetic abnormalities. The Company is ISO 13485:2016 certified and operates to a quality management system which is in compliance with the EC in vitro Diagnostic Directive (98/79/EC).
The Company has been audited against the requirements of the In Vitro Diagnostic Directive (98/79/EC) and recommended by Notified Body BSI NL for an EC certificate demonstrating full quality assurance system approval.
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.
Yourgene Genomic Services has ISO 15189:2012 accreditation for its COVID-19 testing and sequencing services. Assessments under UKAS ensure that laboratories meet the relevant requirements including the operation of a quality management system and the ability to demonstrate that specific activities are performed within the criteria set out in the relevant standard. ISO 15189:2012 accreditation provides confidence that Yourgene’s medical laboratories deliver quality levels of performance and competence and confirms that the Company is operating a clinical service that is safe, reliable and consistent conveying trust to stakeholders and decision-makers and allows for a more rigorous system in operation.
IVDR Readiness Statement:
The In Vitro Diagnostic Regulation (IVDR 2017/746) will replace the current In Vitro Diagnostic Directive (IVDD 98/79/EC) with the date of application on 26 May 2022. In January 2022, the European Commission published an extension to the transition timelines, but the date of application remains the same. The full timeline overview of IVDR implementation, including the updated transition timelines, is provided below.
IVDR provides the regulatory framework for safe and effective tests for the benefit of patients and to ensure the present and future availability of our products, under the new European Regulations.
As a responsible IVD manufacturer we are pleased to embrace these enhanced regulations and, although with the extended transition timelines we have until 2026 to transition many of our devices, we are actively working to fulfill the IVDR requirements for our devices prior to the end of the transition period to meet the needs of our customers and to support the health decisions of their patient populations.
Yourgene have established an “IVDR Project” with an intent to ensure our systems are fully compliant with the IVDR requirements and ensure devices are subject to the appropriate assessment and transition without any impact to customers.
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Yourgene Health Taiwan approved LDTS
NIPT Trisomy 13, Trisomy 18, Trisomy 21 and Sex Chromosome Aneuploidies (SCAs)