IVD CRO services built for the complexity of global regulatory submissions.
Clinical performance studies, regulatory strategy, and IVDR compliance, delivered by a team that understands IVD regulation as deeply as the science behind your device.
From companion diagnostics to NGS and molecular testing, we cover the full regulatory and clinical spectrum.
What our clients say
FULL-SPECTRUM IVD CRO SERVICES
From initial regulatory mapping to post-market surveillance, MDx CRO covers every stage of IVD development and approval. Most clients begin with one service and expand the engagement as the project evolves.
Most IVD project delays are regulatory, not scientific.
When a study fails Notified Body review or a submission requires complete redesign, the cause is rarely the device. It is almost always a regulatory strategy that was not built for IVD from the start.
Misclassification and incorrect regulatory pathways cost months.
A general medical device CRO applies MDR logic to IVD projects. The risk classification frameworks are different, the evidence requirements are different, and the Notified Body expectations are different. Classifying an oncology companion diagnostic as Class A when it is Class C means redesigning the entire dossier — typically a six-month setback, minimum. MDx CRO works exclusively in IVD. We get classification right at the start, and we design every study and technical file around the regulatory pathway that will actually apply to your device.
Patient and sample access is the most underestimated risk in IVD study planning.
Enrollment shortfalls, insufficient sample availability, and underpowered studies are among the most common reasons IVD clinical performance studies fail to deliver usable results. The consequences extend beyond timeline, an underpowered study means insufficient statistical evidence for regulatory submission, which means redesign, re-study, and significant cost. MDx CRO anticipates access constraints at protocol design stage. We combine biostatistical rigour with operational experience across clinical sites to build studies that are realistically executable, and regulatorily sound.
Regulatory accountability cannot be an internal burden alone.
Heads of regulatory affairs and clinical teams in IVD manufacturing organisations carry significant pressure from senior management around compliance timelines and submission outcomes. The value of a specialist IVD CRO is not only technical — it is the shared accountability for a result. MDx CRO acts as a regulatory partner, not a vendor. We bring the strategic guidance, the Notified Body relationships, and the multidisciplinary expertise — scientists, regulatory affairs specialists, medical writers, QA professionals, and former Notified Body reviewers — so your team is not navigating complex submissions alone.
IVD CRO vs. General Medical Device CRO
Many manufacturers make the mistake of hiring a general CRO for IVD projects. General CROs often over-test, misunderstand risk classification, lack Notified Body relationships, and don’t coordinate companion diagnostics properly.
An IVD CRO specialist like MDx understands this hierarchy. We know which regulatory pathways apply to oncology CDx, molecular testing, and general IVDs. We classify risk correctly the first time. We design validation studies that satisfy Notified Bodies without over-testing.
| Aspect | IVD CRO | General Device CRO |
|---|---|---|
| Regulatory Focus | IVDR, MDR (diagnostics) | MDR (devices) |
| Evidence Required | Analytical validity | Clinical performance |
| Typical Timeline | 12–18 months (Class B/C) | 18–36 months |
| Lab Expertise | Deep (analytical validation) | Limited |
| Companion Diagnostics | Dual regulation expertise | Limited experience |
Frequently Asked Questions about IVD CRO Services
Contact and expert in IVD-
What is the difference between an IVD and a medical device?
An In Vitro Diagnostic (IVD) is a test performed on a sample (blood, tissue, urine) to detect disease, infection, or genetic conditions. A medical device is used directly on or in the patient’s body. IVDs are regulated under IVDR in Europe and specific FDA rules in the USA. Medical devices are regulated under MDR in Europe.
Companion diagnostics are IVDs that are co-regulated with pharmaceutical or biologic drugs. So a CDx faces both IVD regulation AND drug regulation, which is why specialized expertise is critical.
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What is the fastest timeline for IVDR approval?
A: IVDR Class A devices (low-risk) can achieve conformity in 3-6 months if documentation is complete. Class B takes typically 12-18 months. Class C/D can take 18-36+ months.
At MDx, our track record shows 25-30% faster timelines than industry average, around 12-14 months for Class B, because we design dossiers for approval, not just compliance.
Timelines are driven by:
- Risk classification complexity
- Quality of your initial regulatory strategy
- Availability of existing validation data
- Notified Body workload and preferences
- How well you respond to regulatory queries
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Do we need IVD CRO support for FDA submission?
Yes, especially if you’re developing a companion diagnostic or high-risk LDT. FDA’s regulatory landscape for IVDs is complex and evolving. Companion diagnostics co-developed with drugs face particular complexity because they must satisfy both FDA IVD rules and drug approval requirements.
We help biotech companies coordinate parallel submissions efficiently so both pathways advance together.
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What is EUDAMED and why does it matter?
EUDAMED is the European database where all IVDR device information must be registered. It’s a public database containing device identification, manufacturer information, Notified Body information, post-market surveillance summaries, serious incident reports, and performance updates.
Registration is mandatory post-approval and must be kept up-to-date. Regulators actively monitor EUDAMED. Non-compliance can lead to warnings or enforcement action.
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Are companion diagnostics regulated differently from other IVDs?
A: Yes, significantly. A companion diagnostic (CDx) is an IVD that has a documented association with a specific drug or biologic. CDx face dual regulation:
- IVDR (or FDA IVD rules) as a diagnostic
- Drug approval pathway (EMA or FDA) as a therapeutic companion
This means analytical validation serves both regulatory submissions, clinical performance may be demonstrated through drug trials, and timeline coordination between diagnostic and drug teams is critical.
This is where specialized CDx expertise makes a huge difference. We coordinate these parallel pathways so both teams win.
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What is the most common mistake we see in IVD projects?
The most common mistake is misclassifying the device’s risk category. Manufacturers often underestimate complexity and classify as Class A when it’s really Class B or C. This leads to wrong dossier structure, insufficient validation data, unexpected Notified Body involvement requirements, and 6+ month delays.
That’s why our first step is always a rigorous risk assessment. We get classification right the first time.
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What happens post-approval? Do we still need CRO support?
Yes. Post-market surveillance is mandatory and ongoing. While many CROs “hand off” at approval, we continue to support EUDAMED registration, adverse event monitoring system activation, performance monitoring planning, periodic safety update reports, and regulatory liaison.
Think of PMS not as an afterthought, but as the foundation for your device’s long-term market success.
One question MDx CRO hears consistently from new clients is some version of: do you actually understand my device and its regulatory path? It is a fair question. The IVD regulatory landscape, particularly post-IVDR, has become significantly more demanding, and the cost of working with a partner who does not fully understand it is measured in months and in redesigned submissions.
Catarina Sepúlveda, IVD Director at MDx CRO, has spent her career at the intersection of IVD science and regulatory strategy.
The role of a specialist IVD CRO is not simply to execute studies, but to act as a regulatory translator, converting the complexity of IVDR, FDA requirements, and Notified Body expectations into a clear, executable strategy for the manufacturer.
What clients are really looking for, as Catarina describes it, is regulatory confidence. Not just a passed submission, but the assurance that the strategy behind it was sound: that the claim wording is defensible, that the study design will hold up to scrutiny, and that if a Notified Body raises a question, there is an expert in the room who has seen that question before and knows how to answer it.
She also points to something less discussed in the industry: the value of predictability. Involving a specialist IVD CRO does not always mean a faster timeline. It means a more predictable one. Manufacturers can make better business decisions when they have a realistic, evidence-based view of what the regulatory path will require and how long it will take. That clarity, she notes, is itself a form of risk reduction.
Ready to Launch Your
IVD on IVDR?
Our IVD CRO team has guided 35+ biotech and pharma companies from concept to market approval. Whether you’re developing an oncology companion diagnostic, laboratory-developed test, or precision medicine IVD, we understand the regulatory landscape and can accelerate your path to compliance.
We specialise in what other CROs miss: the intersection of clinical expertise, analytical validation, regulatory intelligence, and Notified Body relationships that turns complex IVD projects into successful launches.
