Since 2021, omnomicsNGS has held the CE-IVD mark under the In Vitro Diagnostics Directive (IVDD 98/79/EC). Euformatics Quality Manager Ashwini Nagaraj shares insights into the significance of CE-IVD certification, its impact on clinical practice, and its critical role in transition to the more stringent requirements of the In Vitro Diagnostics Regulation (IVDR). She highlights how achieving and maintaining CE-IVD certification under the IVDD establishes a strong foundation for compliance with IVDR, ensuring tools like omnomicsNGS meet the highest standards of safety, reliability, and regulatory compliance. This transition underscores the importance of IVD-certified tools in delivering trustworthy and effective solutions in the evolving landscape of clinical diagnostics.
What does it mean to be IVDD compliant and how does it help in moving towards IVDR certification?
The world of CE-marking, particularly under the stricter IVDR framework, can often be complex, leaving many uncertain about its value and relevance. Here, we aim to clarify the meaning of CE-IVD certification, its importance in ensuring compliance with the highest regulatory standards, and why it should matter to you as a clinician working with NGS-based diagnostic tools.
With the In Vitro Diagnostic Regulation (EU 2017/746) now fully in effect, understanding CE-IVD certification has become more important than ever. But what exactly is CE-IVD, and how does it impact you? If you’ve encountered the term CE-IVD in medical diagnostics, you might wonder what it entails and why it’s significant. Whether you’re a healthcare professional, a laboratory technician, or a patient, understanding CE-IVD can clarify its importance in ensuring the safety and reliability of diagnostic tests.
CE (Conformité Européenne): This mark indicates conformity with EU health, safety, and environmental protection directives. It’s a legal requirement for many products sold within the European Economic Area (EEA).IVD (In Vitro Diagnostic): Refers to medical devices and tools used for testing samples (like blood, urine, or tissue) outside the body to diagnose diseases, monitor health, or provide clinical insights.
The Importance of CE-IVD for Safe and Effective In Vitro Diagnostic Medical Devices
For Manufacturers:
Regulatory Compliance: Manufacturers must meet strict technical and quality standards outlined by the IVDR to obtain the CE-IVD mark. This includes demonstrating the clinical performance, safety, and reliability of the device.
Market Access: CE-IVD certification is mandatory for selling IVD devices in the EU.
For Laboratories and Healthcare Providers:
Assurance of Quality: Devices with CE-IVD are validated to deliver accurate and reliable results, critical for effective patient care.
Legal Requirements: Using non-CE-IVD devices in the EU may not only be non-compliant but also risk patient safety and lead to legal implications.
For Patients:
Trustworthy Diagnostics: CE-IVD ensures that the tests used to diagnose or monitor your health meet rigorous quality standards.
Safety and Efficacy: Devices with this mark are backed by evidence of their clinical and analytical performance.
The IVDR replaced the IVDD on May 26, 2022. Some key changes include:
Stronger Oversight: More rigorous evaluation of devices by notified bodies.
Risk-Based Classification: Devices are now classified into four risk categories (Class A to D), with Class D representing the highest risk. Devices in higher risk classes require stricter regulatory oversight, including review by notified bodies and clinical evidence of performance.
Emphasis on Clinical Evidence:
Performance Evaluation: Manufacturers must provide comprehensive clinical evidence, including scientific validity, analytical performance, and clinical performance.
Post-Market Surveillance: Continuous monitoring of devices’ performance is mandatory, including periodic safety update reports (PSURs) for higher-risk devices.
Increased Transparency: Comprehensive documentation, detailed labeling, and the implementation of a Unique Device Identification (UDI) system are now mandatory, alongside device registration in EUDAMED.
As of January 2025, omnomicsNGS remains certified as a CE-IVD device under the IVDD 98/79/EC. This certification is a significant milestone toward achieving compliance with the IVDR 2017/746.
Transition Period for Legacy Devices:
Devices registered under the IVDD are designated as “legacy devices” under the IVDR. To facilitate a smooth transition and prevent market shortages, the European Commission extended the transitional periods for these devices (1):
Class D Devices: Transition extended until December 31, 2027.
Class C Devices: Transition extended until December 31, 2028.
Class B and Class A (Sterile) Devices: Transition extended until December 31, 2029.
These extensions provide manufacturers additional time to comply with IVDR requirements, acknowledging the increased demand for notified body assessments.
Notified Body Capacity:
A critical difference between the IVDD and IVDR is the expanded role of notified bodies in the conformity assessment process. Under the IVDR, approximately 80% of IVD devices require notified body involvement, a significant increase from the 20% under the IVDD. As of January 2025, there are 11 notified bodies designated under the IVDR, compared to six at the end of 2021. The list of notified bodies can be accessed through NANDO Database (New Approach Notified and Designated Organisations).
Implications for omnomicsNGS:
The CE-IVD certification of omnomicsNGS under the IVDD positions it as a legacy device, allowing continued market presence during the extended transition period. This extension is particularly beneficial given the limited number of notified bodies and the increased demand for their services under the IVDR framework.
Next Steps:
Euformatics is actively preparing to meet IVDR requirements for omnomicsNGS. This involves engaging with a notified body for the necessary conformity assessments and ensuring all technical documentation and quality management systems align with IVDR standards.
The extended transition periods provide a valuable opportunity to achieve compliance without disrupting the availability of omnomicsNGS to clinical users. Euformatics remains committed to maintaining the highest standards of quality and regulatory compliance throughout this transition.
Transitioning from IVDD to IVDR
The transition from IVDD to the IVDR represents a significant overhaul of the regulatory landscape. While IVDD certification provides a foundation, aligning with IVDR involves meeting more stringent requirements. Here’s how IVDD certification helps in moving towards IVDR compliance:
1. Existing Quality Management Systems (QMS)
Under IVDD: Manufacturers must have a quality management system in place, typically based on ISO 13485 quality standard.
Transition Advantage: Many of the existing QMS frameworks can be expanded to meet IVDR’s stricter requirements, such as post-market surveillance and performance evaluation.
An IVDD-certified QMS serves as a starting point, reducing the groundwork needed to adapt to IVDR requirements.
2. Familiarity with Risk Management
Under IVDD: Manufacturers already perform basic risk management, including device classification and identifying potential hazards.
Under IVDR: The process becomes more detailed, with a risk-based classification system and extensive clinical evidence requirements.
Existing risk management experience makes it easier to integrate the more comprehensive IVDR protocols.
3. Existing Clinical Performance Data
Under IVDD: Devices must demonstrate analytical performance, often with less emphasis on clinical evidence.
Under IVDR: A robust performance evaluation is required (2), including clinical evidence of the device’s safety, scientific validity, and intended use.
Manufacturers with IVDD-certified devices can build on their analytical data to meet IVDR’s expanded clinical performance requirements.
4. Product Traceability Systems
Under IVDD: Basic traceability is required but not as stringent.
Under IVDR: A Unique Device Identifier (UDI) system is mandatory for traceability and lifecycle management.
Existing traceability systems provide a framework for implementing the more detailed UDI requirements.
5. Technical Documentation Foundation
Under IVDD: Technical documentation is required, though less detailed than under IVDR.
Under IVDR: Documentation must include more extensive data on device design, performance, and risk management.
Manufacturers can expand and refine existing IVDD technical files to align with IVDR’s comprehensive documentation requirements.
6. Experience with Notified Body Interaction
Under IVDD: High-risk devices required notified body involvement.
Under IVDR: Most devices, except low-risk Class A, now require notified body review.
Manufacturers familiar with notified body processes under IVDD can adapt more readily to the increased scrutiny under IVDR.
Some of the key challenges in transitioning
Expanded Scope: IVDR applies to more device types, including companion diagnostics and software as a medical device.
Clinical Evidence Requirements: Stronger evidence of clinical utility and real-world performance is required.
Stricter Deadlines: Legacy IVDD certificates are valid only until their expiry dates, necessitating timely transition.
Being IVDD certified provides a solid foundation for IVDR compliance by establishing basic quality systems, risk management, and technical documentation. However, the transition requires significant enhancements in clinical evidence, regulatory processes, and risk-based classification. Starting with a strong IVDD framework can ease the shift, reducing time and resource burdens while ensuring continued market access under the IVDR framework.
The Future of omnomicsNGS
We remain fully committed to IVDR compliance and are actively working towards obtaining IVDR certification to meet its rigorous requirements. This underscores our dedication to delivering high-quality, reliable, and compliant solutions for our users. The validation of genomic variant interpretation continues to present challenges, but as NGS technologies further revolutionize disease treatment and NGS-based testing gains widespread adoption globally, we are dedicated to staying at the forefront. Our focus is on delivering advanced software tools that empower users to maximize the value of their genomic data, driving better outcomes and innovation in precision medicine.
Why Choose a Certified Variant Interpretation and Reporting Tool?
A certified tool ensures compliance with current regulations and the rigorous standards required by the IVDR. Here’s why it’s essential:
Proven Compliance
IVD certification, particularly CE-IVD marking, is a testament to the tool’s adherence to strict regulatory standards. It confirms that the manufacturer has conducted thorough validation of the device for its intended use.
Reliability and Safety
Manufacturers of CE-IVD-marked devices are required to continuously validate their products and implement improvements. This commitment ensures the tools remain reliable, effective, and safe for clinical applications.
Preference in Clinical Applications
In tendering processes for clinical applications, CE-IVD-marked devices are often preferred over research-use-only (RUO) tools. This makes them a more practical and dependable choice for clinical laboratories and healthcare providers.
Choosing an IVD-certified variant interpretation and reporting tool provides confidence in its accuracy, reliability, and compliance with the regulations, ensuring high-quality outcomes in clinical settings.
References:
Panizzi,Claudia (2024) “IVDR: What Does It Mean for Manufacturers of In Vitro Diagnostic Devices?”, Regulatory Affairs. Available at: https://blog.pqegroup.com/regulatory-affairs/ivdr-what-does-it-mean-for-manufacturers-of-in-vitro-diagnostic-devices?.
Gould, Fiona (August 17, 2022) “Performance evaluation under IVDR,. The Compliance Navigator for Medical Devices. Available at: https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/performance-evaluation-under-ivdr/.
If you are doing NGS tests and want to be compliant with IVDR then please get in touch. We would be glad to work with you to help ensure that you are IVDR compliant.
To find out for yourself how omnomicsNGS can make a difference to the way you work and book your free demo today.
