In the world of diagnostic technologies, symbols on the label are crucial. They’re declarations of safety, intent, and regulatory compliance. Among the most crucial of these is the CE‑IVD mark, often seen on equipment and reagents used in clinical diagnostics across Europe. But what exactly does CE‑IVD mean, and how does it compare to other terms like RUO or “for performance evaluation only”? Let’s demystify it.
The CE‑IVD Mark: A Passport to Clinical Use
The term CE‑IVD stands for “Conformité Européenne – In Vitro Diagnostic.” This designation is granted to devices that meet the stringent requirements of the European In Vitro Diagnostic Regulation (IVDR). Unlike general CE marking, which applies to everything from toys to power tools, CE‑IVD is reserved specifically for medical devices that are used outside the body to examine human samples, things like blood, saliva, or tissue, to diagnose disease, guide treatment, or monitor health.
Achieving CE‑IVD certification involves risk classification, detailed technical documentation, performance evaluations, and often the involvement of a third-party notified body that reviews the safety and efficacy of the device. This process became even more rigorous after the transition from the older IVDD directive to the IVDR regulation in May 2022. Under the new framework, even low-risk devices must maintain robust post-market surveillance and traceability, while higher-risk diagnostics face deeper scrutiny.
RUO: What It Is
Many products in the life sciences space carry a different label: Research Use Only (RUO). These tools are not meant for diagnosing or treating patients. Instead, they’re designed strictly for exploratory work, like biomarker discovery, method development, or basic academic research, for example, a research-grade polymerase chain reaction (PCR) machine. While RUO products are essential for innovation, it’s critical to understand that they fall outside the scope of IVDR.
Using RUO products in a clinical setting is not just frowned upon; it can carry legal and ethical consequences. Without validated performance, patient safety is at risk. Regulators are clear: if a tool influences patient care, it must be CE‑IVD marked. Laboratories found misapplying RUO products in diagnostics could face serious compliance violations.
A Grey Zone: Devices for Performance Evaluation
Between CE‑IVD and RUO sits a more nuanced category: devices labelled “for performance evaluation only”. These are often new diagnostic tools that are undergoing real-world validation or clinical studies. They aren’t yet approved for routine diagnostics, but may be used under controlled conditions where safety and traceability are ensured.
For example, during the early development of the ‘Cepheid Xpert Xpress SARS-CoV-2 test’, units were distributed to selected hospitals and public health labs for performance evaluation before full regulatory clearance. These evaluations helped generate real-world data on sensitivity, specificity, and sample stability, which supported the manufacturer’s final CE‑IVD submission. In this way, performance evaluation devices serve as a critical bridge between R&D and clinical use, enabling manufacturers and labs to work collaboratively while maintaining regulatory integrity.
CE‑IVD certification & the IVDR 2017/746
Under the IVDR, every IVD device placed on the EU market must meet the General Safety and Performance Requirements and declare conformity with applicable standards. How manufacturers get there depends on their device’s risk class:
Classification: First, the device is categorised from Class A (low risk, e.g., non-sterile reagents) to Class D (high risk, e.g., tests for transmissible agents).
Technical documentation & QMS: The manufacturer builds thorough technical files (as required by IVDR Annexe II/III) and implements a Quality Management System in line with IVDR—here’s where ISO 13485 comes in.
Notified body assessment: For Class B–D (and Class A sterile), an EU‑designated Notified Body audits both the QMS and the technical files.
Certification & market launch: After passing the assessment, the manufacturer obtains a CE‑IVD certificate and can affix the CE‑IVD mark, enabling access to EU markets, and often receives ISO 13485 certification simultaneously
Under IVDR, high‑risk IVDs also require post-market surveillance, clinical evaluation, traceable UDI marking, and compliance with EUDAMED registration, all of which tie back into a robust QMS. The IVDR legally came into force on May 26, 2022, with transitional deadlines up to 2029 depending on risk class
REAL LIFE CASE-STUDY: The airport deployment that validated a 15-minute PCR test
In May 2022, Brussels Airport was still grappling with the tail end of the pandemic. Travellers moved through crowded terminals, faces masked, eyes scanning departure boards. In the middle of this busy, high-stress environment, a quiet breakthrough took place, a chip-based PCR test, built for rapid, on-site COVID-19 screening, was being put to the test.
Developed by Belgian startup miDiagnostics, a spin-off from nanoelectronics powerhouse imec, this wasn’t just another COVID test. It was CE‑IVD certified, clinically validated, and capable of delivering lab-quality results in just 12–15 minutes. All of this was packed into a card-sized device that performed on par with standard RT-qPCR.
What made this different wasn’t just the tech — it was how it was tested. Before full market approval, miDiagnostics deployed the test at Brussels Airport under a "performance evaluation" scheme. Instead of controlled lab settings, the test was trialled in one of the busiest, most unpredictable environments possible. The pilot involved 766 participants and produced clinical data on sensitivity, specificity, sample stability, and usability, all of which fed into the CE‑IVD approval process.
Once certified, that same test became a trusted part of Europe’s decentralised testing infrastructure, a tool built for the real world, proven in the real world.
ISO 13485: The Backbone of CE‑IVD
ISO 13485 is a harmonised standard outlining QMS requirements tailored for medical device and IVD manufacturers. While certification to ISO 13485 isn’t always legally mandatory, it is effectively required to successfully navigate Notified Body assessments under IVDR, especially for Class B–D devices.
ISO 13485 focuses on:
Quality system processes across design, manufacturing, validation, and services.
Detailed documentation, including SOPs, traceability, and change control.
Risk management compliance (aligned with ISO 14971).
Post‐market surveillance, corrective/preventative actions (CAPA), and supplier management.
Defining roles like the ‘Person Responsible for Regulatory Compliance’ (PRRC) under IVDR.
Because ISO 13485 aligns so well with IVDR requirements, excelling in this standard is nearly synonymous with preparing for CE‑IVD approval
MANTA: A CE‑IVD Success Story
At Cambrian Bioworks, we’re proud to announce that MANTA, our automated nucleic acid extraction system, has received CE‑IVD certification under Regulation (EU) 2017/746. This is a testament to MANTA’s performance, safety, and clinical reliability.
Designed for high-throughput DNA and RNA extraction, MANTA now officially meets the rigorous standards required for diagnostic use in Europe. It has passed analytical validation and was reviewed for clinical performance, robustness, and traceability. Whether you're running a single sample or a full 32-sample batch, MANTA delivers results with consistency and compliance baked in.
More importantly, the CE‑IVD mark allows diagnostic labs across the EU to confidently integrate MANTA into patient-facing workflows, knowing it adheres to the highest standards of medical regulation. Unlike RUO instruments, MANTA is built for direct impact in clinical settings, supported by quality systems that meet ISO 13485 standards.
For more information on Manta and how it can fit into your lab, get more details here.
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