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 15189:2022 accreditation for its NIPT 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 15189:2022 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.
A Quality & Regulatory perspective on IVDR
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.
IVDR FAQs
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.
Summary of IVDR Scope and Key Dates
The European Union In Vitro Diagnostics Regulation 2017/746 (EU IVDR) expanded upon IVD Directive 98/79/EC (IVD-D) requirements, which have been in effect since 1998. The changes come into effect immediately, without having to be implemented into the respective states’ laws.
Whilst some things, like the number of risk device classes, are remaining the same, the scope of the IVDR changes are wide reaching, with key changes as follows:
- Product scope expansion
- Reclassification of devices according to risk
- More stringent clinical evidence
- More stringent documentation
- Implementation of unique device identification
- Rigorous post-market surveillance
- Nomination of a responsible person for regulatory compliance
- Increased Notified Body involvement
The intention of the regulation is to set tighter and broader requirements for the quality, performance and safety of IVD products, with implications for both manufacturers and consumers.
Learn more about Yourgene’s IVDR timeline on our Quality section of our website.
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.
If you have any questions about IVDR, please contact dpyd@yourgenehealth.com to speak with an expert.
Who is affected by IVDR?
The reach of The European Union In Vitro Diagnostics Regulation 2017/746 (EU IVDR) extends to all EU member states, plus all European Free Trade Association States and EEA territories, with implications for both manufacturers and consumers.
Regulatory requirements will be more demanding under the IVDR for all IVD devices, but the need to prove compliance to a notified body prior to CE marking will increase the burden on the manufacturers and result in a higher cost of regulatory compliance.
The strengthened requirements are all intended to reduce risk, for both users and patients. To this end, devices continue to be certified by an appointed Notified Body (NB) according to risk class (See graphic below)
“In some cases, it may not be possible to generate adequate proof of compliance with the new requirements. These factors may result in some devices no longer being commercially viable.” – BSI Medical Device White Paper Series, Explaining IVD classification issues.
If you have any questions about IVDR, please contact dpyd@yourgenehealth.com
What does IVDR mean for me?
The EU IVDR holds manufacturers of in vitro diagnostic devices (IVDs) to a higher standard. Conformity assessment requirements of IVDR specify that manufacturers must provide, among other things, considerable evidence of scientific validity, as well as data demonstrating analytical and clinical performance of the devices.
Because of this, there are also implications for users of IVDs, and significant requirements for labs who develop and run their own “in-house devices” as part of workflows intended for clinical use.
Users of laboratory-developed tests (LDTs) who wish to continue to do so beyond the May 2028 deadline will be required to prove that their home-brew test(s) fulfil Article 5(5) requirements, which briefly state:
– Experience from clinical use regularly reviewed and corrective action taken if necessary
– Information (including justification of manufacture, modification and use) is available on request to the competent authority
– Specific needs of the target patient group cannot be met to an appropriate level of performance by a commercially available CE-IVD
– Device cannot be made on an industrial scale, or transferred outside of the health institution
– Device manufacture/use occurs under an appropriate Quality Management System
– Device meets general safety and performance requirements set out in Annex I
– Laboratory is compliant with ISO:15189 (or equivalent) standard
To summarise, if a laboratory intends to continue using their own LDT, they adopt the role of a manufacturer and must undertake the onerous task of compiling the relevant data.
If you have any IVDR questions, please contact dpyd@yourgenehealth.com to speak to an expert
Under the European Union In Vitro Diagnostics Directive 98/79/EC (IVD-D), approximately 8% of IVDs required Notified Body involvement.
Under European Union In Vitro Diagnostics Regulation 2017/746 (EU IVDR), approximately 80% of IVDs require Notified Body involvement.
Given that there are 34,000 companies within the European medical device sector, and only 36 designated notified bodies for IVDR, the limited capacity of the notified bodies plus a slower than expected uptake and recognition of the regulation has contributed to the protracted timelines of the transition to this point.
If you have any questions about IVDR, please contact dpyd@yourgenehealth.com to speak to an expert
What does IVDR status mean?
A product with IVDR certification enables clinician and patient confidence in a superior high quality test – where accuracy matters
Yourgene DPYD: One of the first examples of an IVDR pharmacogenomics test that will continue to have a positive impact on cancer patients’ lives
Our IVDR Status:
The In Vitro Diagnostic Regulation (IVDR 2017/746) replaced 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 2028 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.
- In November 2023, we had our first product to receive IVDR certification, with the Yourgene DPYD assay!
- We are thrilled to have our first IVDR product in our Reproductive Health portfolio, with Yourgene Cystic Fibrosis Base!
- Yourgene QSTR Base for Rapid Aneuploidy Analysis is also IVDR.
- Click here to view the certificate, or visit our Certification section.
Please contact info@yourgenehealth.com for further information.
MedTech Europe welcomed the adaption of the European Commission’s amendment to the In Vitro Diagnostic medical devices Regulation (IVDR) by the European Parliament and the EU Council, that has been published in the Official Journal of the EU. Since this publication date, the amendment is fully applied in all Member States and has the effect of:
- Maintaining the date of application of the IVD regulation of May 26, 2022;
- Extending the IVDR transitional provisions by 3–6 years depending on the IVDR risk class
- No change for CE-marked devices that do not require notified body involvement under the IVD regulation (class A non-sterile, like e.g. instruments and sample preparation devices), or for devices that are ‘new’, i.e. devices that have neither a notified body certificate nor a declaration of conformity under the current Directive 98/79/EC. For those types of devices, the IVD regulation therefore applies from May 26, 2022 as planned.
| Device Class | IVDR compliant QMS | Officially applied to a NB | Formal written agreement with a Notified Body signed | Transition deadline |
|---|---|---|---|---|
|
IVDD certified devices*
|
26 May 2025
|
26 May 2025
|
26 September 2025
|
31 December 2027
|
|
Class D self-declared
|
26 May 2025
|
26 May 2025
|
26 September 2025
|
31 December 2027
|
|
Class C self-declared
|
26 May 2025
|
26 May 2026
|
26 September 2026
|
31 December 2028
|
|
Class B and A-Sterile self-declared
|
26 May 2025
|
26 May 2027
|
26 September 2027
|
31 December 2029
|
Read more about the amended provision here: MedTech Europe.
Read the Official Journal of the European Union amending Regulation (EU) 2022/112.
IVDR Certification
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