Yourgene Health UK Ltd is certified to ISO13485:2016 and ISO 9001:2015, the internationally recognised standards for quality management systems. These certifications reflects our commitment to operational excellence, continuous improvement, and delivery of high-quality products and services that consistently meet customer expectations.
To support our global commercial reach, our quality management system (QMS) aligns with the Medical Device Single Audit Program (MDSAP) for Australia and Canada. This single, comprehensive framework satisfies the stringent regulatory requirements of the following country specific requirements:
Also meets the UK MDR 2002 requirements.
The Company has been audited by Notified Body BSI NL against the requirements of the in Vitro Diagnostic Regulation (IVDR 2017/746 Article 110 and IVDR 2017/746 Annex IX Chapter I and III
Yourgene Genomic Services Ltd have ISO 15189:2022 accreditation for their NIPT sequencing services. ISO 15189:2022 accreditation by UKAS provides independent assurance that our laboratories operate to an internationally recognised standard.
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 15189:2022 accreditation provides confidence and assurance to patients, clinics, and stakeholders that Yourgene’s medical laboratories deliver quality and reliable levels of performance and competence and confirms that the Company is operating a NIPT clinical service that is safe, reliable and consistent conveying trust to stakeholders and decision-makers and allows for a more rigorous system in operation.
Regulatory excellence is a core capability of the Yourgene clinical team, underpinned by a strong track record in developing and commercialising approved in vitro diagnostic (IVD) assays. This includes the landmark achievement of the IONA® test, the world’s first NIPT assay to receive CE marking in 2015. The introduction of the In Vitro Diagnostic Regulation (IVDR 2017/746), which replaces the previous In Vitro Diagnostic Directive (IVDD 98/79/EC), has significantly increased regulatory requirements across the industry, establishing a more robust framework to ensure the safety and performance of diagnostic tests. Against this evolving regulatory landscape, our experienced Regulatory team continues to successfully navigate increasing complexity, supporting the registration and commercialisation of our products across multiple international markets. In addition to Europe and the United Kingdom, our assays are registered and available in key international markets including Australia and Canada, among others.
We have achieved IVDR certification for several key assays, including the recently launched Yourgene® Insight DPYD Assay, the Yourgene® DPYD Assay, the Yourgene® Cystic Fibrosis Base Kit and the Yourgene® QST*R Base Assay. Further products are progressing through the IVDR submission and approval process, supporting the continued expansion of our clinical portfolio.
In this edition of Your Expert, Yourgene’s Head of Quality Assurance and Regulatory Affairs (QA/RA) Claire Ryan shines a light on the European Union In Vitro Diagnostics Regulation 2017/746 (EU IVDR) to de-mystify some of the remaining questions around the changes, what it means for Yourgene Health and the impact on their current IVD users.
Yourgene are committed to sharing our IVDR expertise with our distribution partners and end users – we will be bringing you informative content to help guide you through your IVDR fears.
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 Regulation (IVDR 2017/746).
The In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) is the current legally binding regulatory framework governing the safety, performance, and commercialisation of in vitro diagnostic medical devices (IVDs) within the European Union. It officially entered into force in May 2017 and became fully applicable on 26 May 2022, completely replacing the old In Vitro Diagnostic Directive (98/79/EC) (IVDD).
The regulation dramatically overhauls how diagnostic tests—ranging from simple blood sugar monitors to complex genetic assays and cancer screening software—are scrutinised before and after they reach the EU market.
The most significant impact of the IVDR is the elimination of widespread manufacturer self-certification. Under the old directive (IVDD), roughly 80% to 90% of IVDs could be placed on the market based solely on the manufacturer’s own declaration of compliance. Under the IVDR, this structure is inverted: an estimated 80% to 90% of all IVD products now require independent, third-party oversight by a designated Notified Body.
Key Pillars of the Regulation:
For the first time, “in-house” tests—diagnostic assays manufactured and used entirely within the same health institution or clinical laboratory—fall under targeted regulatory constraints. While they are exempt from standard CE-marking procedures, health institutions must meet strict manufacturing, quality management, and justification rules to prove that no equivalent commercial CE-marked alternative is available on the market.
Regulation (EU) 2024/1860 is a legislative act of the European Parliament and of the Council adopted on 13 June 2024. It amends the existing Medical Devices Regulation (MDR) – (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (IVDR) – (EU) 2017/746. The regulation entered into force on 9 July 2024 and aims to prevent shortages of critical medical devices, mitigate supply disruptions, and provide manufacturers more time to transition safely to the stricter regulatory frameworks. his much anticipated publication is relevant for all medical device and IVD manufacturers marketing, or intending to market, their devices in the EU.
Three Core Pillars of the Regulation
All parties operating under the provisions of the MDR and IVDR will have some level of responsibility in relation to use of EUDAMED. Following publication of Regulation (EU) 2024/1860, the use of the modules that are already available will become mandatory without the requirement to wait for the readiness and implementation of all modules.
On 10th July 2024, one day after the publication of Regulation (EU) 2024/1860, the European Commission released an updated timeline illustrating the current planning for the gradual roll out of EUDAMED. The updated EUDAMED timeline are as follows: EUDAMED modules timeline
The extended timelines apply to legacy devices that were previously compliant under the old Directive 98/79/EC (IVDD), provided specific quality management system (QMS), Post Market surveillance and vigilance conditions are met and no significant changes can be made:
These extensions apply only to legacy devices that have previously been CE marked under the IVD Directive. All new devices must comply with IVDR prior to being placed on the market.
Non-sterile class A devices do not benefit from any extension. Devices falling into this category already require CE marking under IVDR in order to be placed on the EU market.
As a responsible IVD manufacturer we are pleased to embrace these enhanced regulations and, although with the extended transition timelines we have until December 2028 to transition many of our devices (December 2027 for NIPT Test), 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.
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