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 manufacturer 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.
Yourgene Genomic Services in Manchester is Care Quality Commission (CQC) registered. CQC is an independent regulator of health and social care in England. The Yourgene Genomic Services COVID-19 testing and sequencing services are ISO15189:2012 accredited. Yourgene Laboratory Services in Taipei is ISO17025 accredited and TAF (Taiwan Accreditation Foundation No: 2738) certified.
IVDR Readiness Statement:
The In Vitro Diagnostic Regulation (IVDR) 2017/746/EU will replace the current In-Vitro Diagnostic Directive (IVDD 98/79/EC) on 26 May 2022. The full Timeline overview of IVDR implementation 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 we intend to fulfil IVDR requirements for our IVD products and supporting Systems until the end of the transition period and beyond, in order to meet the needs of our customers and to support the health decisions of their patient populations.
Yourgene Health has established the “IVDR Project” with an intent to continue to supply our key products into IVDR regulated territories from May 2022 and we have developed a series of measures to achieve IVDR readiness.
The Yourgene Health implementation strategy includes but is not limited to:
- New risk-based classification system
- Consequent modified conformity assessment processes
- Designated IVDR notified body (BSI)
- ISO13485 compliant Quality Management System
- Re-Compilation of technical documentation
- Declarations of Conformity under the IVDR Certificate
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