IVD Clinical Trials: The Do’s and Don’ts (2026 IVDR Update)

January 26, 2026

What separates a successful IVD clinical performance study from one that gets rejected by a Notified Body? With the IVDR now fully in force, MDCG 2025-5 reshaping how performance studies are planned, and the proposed IVDR targeted revision on the table, the rules have changed significantly since our original article. This 2026 update covers everything IVD manufacturers and sponsors need to know to design, conduct, and report performance studies that meet current regulatory expectations, and avoid the most common pitfalls we see in the field.

Why This Article Needed a 2026 Rewrite

When we first published this guide, the IVD landscape looked very different. Since then, several regulatory milestones have fundamentally changed how IVD clinical performance studies must be planned and executed:

MDCG 2025-5 In June 2025, the Medical Device Coordination Group published 54 Q&A clarifying performance study requirements under IVDR Articles 57–77. This document addresses when studies require competent authority authorisation versus notification, how to handle companion diagnostics, and what constitutes a substantial modification. It has become the go-to reference for sponsors planning studies in the EU.
ISO 20916:2024 with Annex ZA The revised standard now formally maps its clauses to IVDR requirements, creating a single harmonised pathway for clinical performance study conduct. While official recognition as an IVDR harmonised standard in the EU Official Journal is still pending, Notified Bodies are already referencing Annex ZA during reviews.
The proposed IVDR targeted revision (COM(2025) 1023) Published in December 2025, this European Commission proposal includes direct changes to performance study requirements. Among them: performance studies involving only routine blood draws would no longer require prior authorisation, and the mandatory notification for CDx studies using exclusively leftover samples would be removed. This is still a legislative proposal, it must pass through Parliament and Council, but it signals the direction of travel.
IVDR transition milestones for 2026 Under Regulation (EU) 2024/1860, Class C legacy devices must submit a formal IVDR certification application to a Notified Body by 26 May 2026. This means many manufacturers are running performance studies under significant time pressure right now.

These developments make the difference between planning a study that sails through regulatory review and one that stalls at the first checkpoint.

A note on terminology: Under the EU IVDR 2017/746, what was traditionally called an “IVD clinical trial” is formally a clinical performance study. This article uses both terms, as many professionals still search for “IVD clinical trials,” but the regulatory-correct term is clinical performance study. Understanding this distinction matters, using incorrect terminology in submissions has been flagged as a cause of delays by competent authorities.

Understanding the IVDR Performance Study Framework

Before diving into the do’s and don’ts, it is essential to understand the regulatory architecture that governs these studies. Under the IVDR, the performance evaluation of an IVD device rests on three pillars:

Scientific validity — The documented association between an analyte and a clinical condition or physiological state (IVDR Article 2(37)).
Analytical performance — The ability of the device to correctly detect or measure a particular analyte. This is evaluated through bench studies covering parameters like sensitivity, specificity, accuracy, precision, and reproducibility (Annex I, Section 9.1).
Clinical performance — The ability of the device to yield results that are correlated with a particular clinical condition or pathological process, as relevant for the target population and intended user (IVDR Article 2(40)).

Clinical performance studies address the third pillar. They are required by default under IVDR Article 56(4), unless the manufacturer can provide due justification for relying on other sources of clinical performance data such as published literature, routine diagnostic data, or results from previous studies.

MDCG 2025-5 clarifies an important nuance: it is not always required to perform both analytical and clinical performance studies. However, analytical performance must always be demonstrated through study data, while clinical performance may draw on a combination of study results, peer-reviewed literature, and data from routine diagnostics.

The results of all three pillars feed into the Performance Evaluation Report (PER), a mandatory component of IVDR technical documentation reviewed by Notified Bodies during the conformity assessment process.

IVD Clinical Performance Studies: The Do’s

1. Start with a Robust Clinical Performance Study Plan

The Clinical Performance Study Plan (CPSP) is the backbone of your study. Under IVDR Annex XIII, Section 2, and ISO 20916:2024, the plan must define:

Study objectives and clearly formulated endpoints
Target population and specimen types
Inclusion and exclusion criteria
Study design type (observational vs. interventional, this distinction has regulatory consequences for authorisation requirements)
Statistical methodology, including sample size justification
Comparator or reference method selection
Data management procedures
Ethical considerations and informed consent procedures
Risk assessment for study participants

A common mistake is treating the CPSP as a formality. In practice, the CPSP is the first document a competent authority and ethics committee will scrutinise. A weak plan creates downstream problems that are expensive to fix once the study is underway.

2026 consideration: MDCG 2025-5 makes clear that the study design must be aligned with the device’s intended purpose as defined by the manufacturer. The intended purpose drives the scope of the required performance evidence, so any ambiguity in intended purpose will cascade into problems with the study plan, the submission, and ultimately the CE marking process.

2. Determine Your Regulatory Pathway Early

Not all performance studies follow the same regulatory route. Under the IVDR:

Article 58(1) studies require application for authorisation to the competent authority. These include interventional clinical performance studies where the study procedure involves additional invasive specimen collection, or where the results are used to guide patient management.
Article 58(2) studies specifically cover companion diagnostics, which always require authorisation when the CDx is investigational and specimens are prospectively collected.
Article 70 studies involve post-market performance studies using CE-marked devices used within their intended purpose, these generally require notification rather than full authorisation.
Other performance studies, such as those using exclusively leftover samples with no additional invasive procedures, may only need notification or, in some cases, fall outside the scope of Articles 58 and 70.

MDCG 2025-5 includes a decision flowchart (Appendix I) that helps sponsors determine which regulatory route applies to their specific study. Use it.

2026 consideration: The proposed IVDR revision (COM(2025) 1023) would simplify this landscape further, removing the authorisation requirement for studies involving only routine blood draws, and eliminating mandatory notification for CDx studies using exclusively leftover samples. However, these changes are not yet in force.

3. Account for National Variations Across EU Member States

The IVDR provides the regulatory framework, but ethics review requirements are set at the national level. MDCG 2025-5 explicitly reminds sponsors that it is necessary to check national requirements in each Member State where specimen collection occurs.

This means that a multi-country study can face different timelines, documentation requirements, and approval processes depending on the jurisdictions involved. Some Member States have well-established procedures for IVD performance study applications; others are still developing their processes under the IVDR.

Practical tips:

The specimen collection site (not the analysis site) determines which Member State’s regulatory requirements apply (MDCG 2025-5, Q20).
Plan for at least 38 days after notification before implementing any substantial modifications (this can be longer if expert consultation is triggered).
Language requirements for patient-facing documents vary by country.
Some Member States require parallel ethics committee and competent authority submissions; others accept sequential approaches.

4. Invest in Biostatistics from Day One

Biostatistics is not an afterthought, it is a design input. A qualified biostatistician should be involved from protocol development through final analysis. Key contributions include:

Sample size calculation An undersized study produces inconclusive results; an oversized study wastes time and resources. Both are avoidable with proper statistical planning.
Endpoint definition Clinical performance endpoints (sensitivity, specificity, predictive values, diagnostic accuracy) must be precisely defined and measurable.
Bias control Randomisation, blinding, and confounding factor management must be built into the design, not retrofitted.
Statistical analysis plan (SAP) This should be finalised before data collection begins. Post-hoc analysis adjustments are a red flag for Notified Bodies.

Under IVDR Annex XIII, Section 2.3.2, the competent authority may assess the statistical approach, study design, sample size, selected comparators, and choice of endpoints as part of the review process.

5. Use Validated Assays That Represent the Final Product

The IVDs used in clinical performance studies must accurately represent the final product as intended for commercial distribution. This means the device version used in the study should be equivalent, in terms of reagents, protocols, software, and hardware, to what will be placed on the market.

If the device undergoes changes between the study and CE marking, the manufacturer must justify that those changes do not invalidate the clinical performance data. Notified Bodies scrutinise this carefully.

IVDR Annex XIII also requires that analytical performance be established before or in parallel with the clinical performance study. There is no point in demonstrating that a device correlates with a clinical condition if the underlying analytical performance has not been characterised.

6. Follow Good Study Practice, Not GCP

This is a critical distinction that MDCG 2025-5 and industry experts have repeatedly emphasised. IVD performance studies are governed by Good Study Practice (GSP) as defined in ISO 20916, not Good Clinical Practice (GCP) as defined in ICH E6.

GCP was developed for pharmaceutical clinical trials and is referenced in ISO 14155 for medical device clinical investigations. While some principles overlap, the frameworks are different. Submitting a performance study designed under GCP rather than GSP can raise concerns during review and may even lead to rejection.

ISO 20916:2024, with its new Annex ZA, provides the direct link between GSP requirements and IVDR regulatory expectations. Sponsors should design their quality systems and study procedures around this standard.

7. Maintain Rigorous Data Management and Documentation

Data integrity is a central requirement under IVDR and ISO 20916. Your data management plan should cover:

How data will be collected, entered, and verified
Electronic data capture systems and their validation status
Source data verification procedures
Audit trail requirements
GDPR compliance for personal and health data across all participating countries
Data monitoring procedures and triggers for quality review

The Clinical Performance Study Report (CPSR) the final output of the study, feeds directly into the Performance Evaluation Report (PER). Any data integrity issues in the CPSR will compromise the entire PER and, by extension, the CE marking application.

8. Plan for Post-Market Performance Follow-Up from the Start

Under IVDR, clinical evidence is not a one-time exercise. The regulation requires a Post-Market Performance Follow-up (PMPF) plan that describes how the manufacturer will proactively collect and evaluate clinical performance data after the device is on the market.

For Class C and D devices, the PMPF Evaluation Report must be updated annually. Planning the PMPF in parallel with the pre-market study ensures continuity of evidence and avoids gaps that could jeopardise continued market access.

9. Incorporate User Feedback, Especially for Near-Patient and Self-Testing IVDs

Usability and user comprehension data are increasingly important, particularly for IVDs intended for lay users, point-of-care settings, or self-testing. Evidence of appropriate use, comprehension of instructions for use, and error rates should be captured during or alongside the clinical performance study.

This evidence supports compliance with the IVDR General Safety and Performance Requirements (GSPRs) and is expected in the technical documentation reviewed by the Notified Body. MDx’s usability engineering services can help integrate these requirements into your study design.

IVD Clinical Performance Studies: The Don’ts

1. Don’t Confuse Terminology or Regulatory Frameworks

As noted above, using GCP where GSP is required, or referring to your study as a “clinical trial” in regulatory submissions when the IVDR uses “clinical performance study,” can create unnecessary confusion and delays.

Similarly, do not conflate the FDA’s Investigational Device Exemption (IDE) framework with IVDR requirements. While both regulate clinical evidence generation for IVDs, the legal basis, study classifications, submission requirements, and oversight bodies are fundamentally different. An article on running clinical studies under IVDR versus the FDA pathway can help clarify these differences.

2. Don’t Neglect the Application or Notification Step

Depending on the study type (see Article 58(1), 58(2), or 70), your performance study may require formal authorisation from, or notification to, the competent authority in each Member State where specimens are collected. Failing to submit the correct application, or submitting under the wrong article, is a common cause of regulatory delays.

MDCG 2025-5 Appendix I provides a decision tree for determining your obligations. Use it systematically. When in doubt, apply for authorisation rather than merely notifying, it is easier to downgrade than to discover mid-study that you should have applied.

3. Don’t Underestimate Sample Size or Population Selection

A sample size that is too small produces inconclusive results. A sample size that is too large wastes time, budget, and participant goodwill. But more importantly, the study population must be representative of the device’s intended use population.

Under IVDR Annex XIII, the clinical performance study must include participants that reflect the diversity of the real-world target population, including age, gender, disease stage, and comorbidity profiles as relevant. A study conducted exclusively on one demographic may not satisfy Notified Body expectations for generalisability.

4. Don’t Treat Substantial Modifications Lightly

Once a study is authorised or notified, any significant change to the protocol, device, endpoints, or study design may constitute a substantial modification under IVDR Article 71.

MDCG 2025-5 Appendix II provides a non-exhaustive list of changes that may be considered substantial, including:

Changes to the primary endpoint measurement method
Modifications to the device under study (e.g., reagent formulation, software version)
Changes to testing modalities or procedures
Changes to the investigator or study sites
Changes to the statistical analysis plan

Substantial modifications must be notified to the relevant competent authority, and sponsors must typically wait at least 38 days before implementation. Ignoring this requirement can invalidate study data.

5. Don’t Skip the Ethics Review

While the IVDR itself does not impose ethics committee review requirements (these are set nationally), MDCG 2025-5 explicitly reminds sponsors that national ethics requirements must be checked and followed. In most EU Member States, ethics committee approval is required for studies involving human participants, even when leftover samples are used.

Beyond regulatory compliance, ethical oversight protects participants, strengthens the credibility of the study data, and is expected by Notified Bodies reviewing the clinical evidence package.

6. Don’t Rush the Study to Meet Transition Deadlines

With 2026 IVDR transition milestones creating urgency, particularly the 26 May 2026 deadline for Class C Notified Body applications under Regulation (EU) 2024/1860, there is a temptation to cut corners on study design, shorten timelines, or accept suboptimal data quality.

This is counterproductive. A poorly designed or hastily executed study is more likely to result in Notified Body queries, additional evidence requests, or outright rejection, all of which cost more time than doing it right the first time.

7. Don’t Ignore Companion Diagnostic Complexity

Companion diagnostics (CDx) occupy a unique regulatory position. Under the IVDR, CDx performance studies are always subject to Article 58(2) when the CDx is investigational. The regulatory requirements, study design considerations, and evidence expectations are more demanding than for standard IVDs.

For CDx co-development programmes, where the diagnostic is developed in parallel with a therapeutic product, sponsors may also need to coordinate with the European Medicines Agency (EMA) through a pre-submission meeting to align timelines and evidence requirements.

MDCG 2025-5 addresses CDx-specific questions (Q28-Q29), including when a CDx study qualifies as interventional and how leftover samples are handled.

8. Don’t Overpromise the Device’s Performance

Title tags, promotional materials, and even study endpoints sometimes reflect aspirational rather than evidence-based performance claims. The IVDR requires that all performance claims be supported by the clinical evidence package. Overpromising leads to either failed endpoints, misleading data, or post-market compliance issues.

Be transparent about the device’s limitations. Define realistic performance targets based on the state of the art, and design the study to demonstrate what the device actually achieves.

Key Regulatory Updates That Affect Performance Studies in 2026

MDCG 2025-5: What Sponsors Must Know

Published in June 2025, this 54-question guidance document is now essential reading for anyone planning or conducting IVD performance studies. The most impactful clarifications include:

Not all studies need both analytical and clinical components, but analytical performance must always be demonstrated via study data.
Leftover samples can be used in many study types, but the regulatory obligations vary depending on whether the study is analytical or clinical, and whether the IVD is CE-marked.
Specimen collection site determines jurisdiction, not the laboratory analysis site.
“Research Use Only” (RUO) products used with a medical purpose in a performance study become IVDs under the IVDR and must meet all applicable requirements.
Combined studies (medicinal product clinical trial + IVD performance study) are addressed, with specific guidance on sponsor responsibilities.

The Proposed IVDR Targeted Revision

The European Commission’s proposal (COM(2025) 1023), published in December 2025, includes changes that would directly impact performance studies if adopted:

Routine blood draw studies would no longer require prior authorisation, a significant simplification for many analytical and clinical performance studies.
CDx studies using exclusively leftover samples would no longer require mandatory notification.
Combined studies would benefit from a streamlined single-application process aligned with the Clinical Trials Regulation (EU) No 536/2014.

This proposal is still in the legislative process. The European Commission opened a feedback period until March 2026, and final adoption is not expected before late 2026 or 2027. Manufacturers should plan under current rules but stay informed of developments.

IVDR Transition Deadlines

For manufacturers relying on transitional provisions:

Class C devices: Notified Body application due by 26 May 2026.
Written agreement with Notified Body: Required by 26 September 2026 for Class C.
Legacy devices: Must continue to meet post-market surveillance and vigilance obligations under the IVDR, regardless of transitional status.

These deadlines are not flexible. Missing a milestone can mean loss of legal market access.

Summary: Performance Study Checklist for 2026

Before launching your IVD clinical performance study, confirm that you have addressed:

Planning phase:

Intended purpose clearly defined (manufacturer’s responsibility)
Regulatory pathway determined (Article 58(1), 58(2), 70, or other)
MDCG 2025-5 flowchart consulted
Clinical Performance Study Plan aligned with IVDR Annex XIII and ISO 20916:2024
Biostatistician engaged for sample size, endpoints, and SAP
National requirements checked for each Member State involved
Ethics committee submissions prepared

Execution phase:

Device version matches intended commercial product
Analytical performance established before or in parallel with clinical performance study
Data management plan in place with GDPR compliance
Good Study Practice (GSP) followed, not GCP
Substantial modification procedures defined
Safety reporting aligned with IVDR Article 76 and MDCG 2024-4

Reporting phase:

Clinical Performance Study Report (CPSR) prepared
Results integrated into Performance Evaluation Report (PER)
Post-Market Performance Follow-up (PMPF) plan developed
Documentation ready for Notified Body review

How MDx Can Help

Planning and executing an IVD clinical performance study under the current IVDR framework requires regulatory expertise, operational capability, and deep understanding of the evolving guidance landscape.

As a dedicated MedTech and IVD Contract Research Organisation (CRO), MDx supports manufacturers across the full study lifecycle, from protocol design and competent authority submissions to study conduct, monitoring, and reporting. Our team has hands-on experience with CDx companion diagnostics, NGS panels, and IVDs across Class B, C, and D classifications.

Whether you are launching your first IVDR performance study or managing a portfolio of legacy devices under transition pressure, we provide the expertise to navigate the process efficiently and avoid costly delays.

Explore our IVD Clinical Studies services

Contact us to discuss your study

Related Resources

This article was last updated in March 2026. The regulatory landscape for IVD clinical performance studies continues to evolve. For the latest information on IVDR requirements and how they affect your product, contact MDx.

Written by:

Carlos Galamba

CEO

Senior regulatory leader and former BSI IVDR reviewer with deep experience in CE marking high-risk IVDs, companion diagnostics, and IVDR implementation.

MDx CRO at MPP 2025: Aligning Companion Diagnostics and Drug Development under IVDR

October 20, 2025

Precision medicine needs alignment, not lighter rules

Europe’s precision medicine ecosystem advances when diagnostics and medicines move in lockstep. The real bottleneck is not regulation itself; it is the structural divergence between the Clinical Trials Regulation and the IVDR. In our work across oncology and rare disease programmes, we repeatedly see how separate clocks, committees, documentation and reporting streams create avoidable friction. Our message at MPP 2025 was simple: bring both tracks together from the start and design one plan that satisfies clinical utility and regulatory rigor at the same time.

CDx and drug trials: bridging IVDR and CTR

When a biomarker guides enrolment or treatment and the assay is not CE-marked for that purpose, Article 58 triggers a performance study alongside the medicinal trial. That study’s endpoints, analytical validation and risk–benefit narrative must be coherent with the drug protocol, because outcomes like PFS, OS and ORR depend on the test defining the right population. Misalignment costs time; EFPIA’s 2023 evidence shows many sponsors facing six to twelve-month delays linked to IVDR requirements, which ultimately pushes patient access further out.

What MDx CRO presented at MPP 2025 and how it will affect 2026

At the Medtech & Pharma Platform Annual Conference on 16 September 2025 at the Novartis Campus in Basel, Carlos Galamba, CEO at MDx CRO, joined the session “IVDs, CDx & Personalized Medicine: Moving from Compliance to Innovation,” chaired by Fatima Bennai-Sanfourche of Bayer and Andreas Emmendoerffer of Roche. The panel brought together Antonella Baron from the European Medicines Agency, Heike Möhlig-Zuttermeister of TÜV SÜD, and patient advocate David Haerry of Positive Council Switzerland, alongside MDx.

Carlos Galamba of MDx CRO presenting at MPP 2025 in Basel on aligning companion diagnostics with drug development under IVDR. — **Carlos Galamba, CEO at MDx CRO presenting at the MPP conference**

Evidence on delays and the impact on patients

The data are unambiguous: EFPIA’s survey indicates 43 percent of companies estimated six to twelve-month delays due to IVDR, with downstream consequences for trial starts and patient inclusion across major disease areas. Every month lost to mis-sequenced processes or unclear governance is a month patients wait for targeted therapies.

Signals from regulators, notified bodies, and patient advocates

The discussion reflected a clear appetite for convergence. EMA perspectives on embedding companion diagnostics under IVDR, TÜV SÜD’s insights on conformity assessment for CDx, and the patient community’s call for earlier access all point in the same direction: coordinated planning and earlier dialogue across agencies, notified bodies and sponsors.

Key insights for 2026 from the MPP panel and fellow presenters

Compliance versus innovation is the wrong debate. The practical path forward is compliance and innovation together: a single evidence plan, shared endpoints, and a unified risk–benefit narrative that treats the diagnostic and the drug as interdependent elements of one therapy journey. That is how companion diagnostics under IVDR accelerate, rather than delay, precision medicine.

How MDx CRO accelerates CDx from design to approval

MDx builds one cross-functional plan from day one, aligning clinical and device protocols, mapping Article 58 triggers, and sequencing submissions so site start-up and “first sample tested” are not held back by documentation gaps. Our teams scrutinise analytical validation, prepare CPSPs and Annex XIV packages aligned to ISO 20916, and train investigators on device-specific safety reporting and sample flows across multilingual EU sites. This integrated approach has delivered a consistent approval track record for CDx submissions.

Operational playbook for combined studies in Europe

Effective combined studies require clear governance between drug and device sponsors, modular and wave submissions across Member States, separate informed consents for the CDx component where appropriate, and proactive scientific advice with EMA or NCAs for borderline cases. With local regulatory intelligence and language capability across Europe, we coordinate roles and documentation so CTR and IVDR remain synchronised throughout the study lifecycle.

Acknowledgment to MPP and our co-presenters

Our thanks to the Medtech & Pharma Platform Association for convening this timely discussion and to the session chairs and speakers who brought regulatory, conformity assessment and patient perspectives to the same table: Fatima Bennai-Sanfourche, Andreas Emmendoerffer, Antonella Baron, Heike Möhlig-Zuttermeister and David Haerry.

Partner with MDx CRO to make CDx work under IVDR

If your programme depends on biomarker-driven enrolment or treatment decisions, partner with a team that speaks CTR and IVDR fluently. MDx CRO compresses timelines, de-risks submissions and delivers companion diagnostics that make precision medicine real for the patients who need it most

Contact MDx Today

Industry Insights & Regulatory Updates

MDx CRO at ESMO 2025 (Berlin): Advancing IVDR Transitions & Combined Clinical Trials

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MDx CRO at ESMO 2025 (Berlin): Advancing IVDR Transitions & Combined Clinical Trials

October 20, 2025

MDx CRO presented new evidence and hands‑on learnings at ESMO 2025 that reinforce our position as the partner of choice for IVDR transitions and combined clinical trials involving investigational IVDs. We were first author on a poster with Fulgent Genetics and contributors to a Servier poster—both centered on the operational and regulatory realities of bringing high‑impact oncology diagnostics into clinical practice under the EU IVDR.

Highlights from our ESMO 2025 posters

Fulgent Genetics & MDx CRO — MDx CRO first author

Title: IVDR Compliance Challenges in Certifying a Large‑Scale NGS Panel for Hereditary Cancer

What it covers:

Practical blueprint for transitioning a comprehensive, service‑based NGS hereditary cancer panel under IVDR.
Defining intended use and scientific validity across a large gene set; end‑to‑end technical documentation; bioinformatics validation aligned to IEC 62304/82304; and notified‑body engagement strategy.
Lessons on right‑sizing verification/validation and building a living evidence package to support CE‑marking.

Why it matters: Sponsors and lab developers gain an actionable path for moving complex NGS services to IVDR compliance—without slowing clinical programs.

MDx CRO at ESMO 2025 in Berlin presenting a poster on IVDR compliance for NGS large panels for germline disease testing with Fulgent Genetics — **Dr. Marketa Svobodova, Precision Medicine Director & Carlos Galamba, CEO at MDx – Poster presentation at ESMO 2025 in Berlin**

Servier & MDx CRO (CHONQUER study) — MDx CRO contributor

Title: Navigating Regulatory Complexity in Combined Studies under CTR and IVDR (CHONQUER)

What it covers:

How combined trials (drug + investigational IVD) trigger dual oversight under CTR and IVDR and the knock‑on effects for timelines, submissions, and site activation across EU member states.
Operational patterns that accelerate approvals: early CPS planning, consolidated documentation, and aligned ethics/competent authority strategies.

Why it matters: Oncology sponsors can de‑risk global programs by anticipating IVDR‑specific requirements—and partnering with an IVD CRO that has worked both sides of the fence.

MDx CRO presented a poster at ESMO 2025 (Berlin) on combined CTR + IVDR clinical studies with Servier. — **Dr. Marketa Svobodova, Precision Medicine Director at MDx – poster presentation at ESMO 2025 – CHONQUER study, a combined study under IVDR/CTR**

Key takeaways for sponsors

IVDR transitions—end to end. MDx CRO supports dossier strategy, clinical performance studies (ISO 20916), scientific validity, and notified‑body engagement for CE‑marking.
Combined trials, simplified. We design and run CPS and combined CTR + IVDR studies, harmonizing submissions across multi‑country portfolios.
Oncology‑ready operations. Deep experience with molecular prescreening, NGS workflows, and drug–device coordination for precision oncology.

Need a quick debrief? Contact our IVD CRO team for a walkthrough of how these findings translate to your IVDR transition or combined study plan.

FAQs

What does MDx CRO do for IVDR transitions?

We provide end‑to‑end support—from intended‑use definition and scientific validity to clinical performance studies, technical documentation, and notified‑body engagement.

How does MDx CRO support combined CTR + IVDR studies?

We plan and execute CPS and combined trials, consolidating submissions and aligning ethics/competent authority requirements to reduce delays.

Can MDx CRO help with NGS panel validation under IVDR?

Yes. We design right‑sized verification/validation programs and bioinformatics validation aligned with IEC 62304/82304.

Where can I get the ESMO 2025 posters?

Both PDFs are available at the ESMO platform; contact us for a guided readout.

Industry Insights & Regulatory Updates

MDx to Present ESMO 2025 Poster on IVDR CE Marking for Large Germline NGS Panels

European Union flags waving in front of modern office buildings representing MedTech innovation and regulatory environment.

MDx CRO at MPP 2025: Aligning Companion Diagnostics and Drug Development under IVDR

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EU AI Act and Medical Devices: What SaMD Developers Need to Know (2026)

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Companion Diagnostics IVD Consultancy within the EMA Framework: Comprehensive Guidance

August 8, 2023

The field of companion diagnostics IVD (CDx) represents a confluence of technological innovation, regulatory compliance, and patient care. As personalized medicine becomes an integral part of healthcare, the regulatory framework governing CDx, including the In Vitro Diagnostic Medical Devices Regulation (IVDR), has become more complex. This scenario calls for a specialized companion diagnostics consultancy. MDx CRO is at the forefront of this arena, offering expertise and guidance in the process for CDx consultation with the European Medicines Agency (EMA), Notified Body preparation and IVDR compliance within the European Union (EU).

Companion Diagnostics IVD and their Role

CDx are in vitro diagnostic (IVD) tests designed to provide information that is essential for the safe and effective use of a corresponding medicinal product. Their applications could include:

Identifying patients who are most likely to benefit from a particular therapeutic product.
Determining patients’ suitability for specific treatments.
Monitoring responses to ongoing treatments.

The Impact of IVDR on Companion Diagnostics

The IVDR sets out robust legal requirements for in vitro diagnostic medical devices, including CDx. Key aspects include:

Enhanced Patient Safety: Ensuring the quality and reliability of CDx IVDs.
Stricter Oversight: Increased scrutiny of the CDx development and approval process. Unlike the previous directive, CDx now require conformity assessment by a Notified Body, an independent organization designated to assess the compliance of medical devices and in-vitro diagnostics. In addition, CDx are also assessed by a medicines authority, most likely the EMA (European Medicines Agency), but a competent authority could also be involved .
Comprehensive Technical Documentation: Increased clinical evidence requirements are particularly notable in the IVDR. MDx CRO can help CDx manufacturers and their drug partners gather the necessary data to support their CDx application. This data may include clinical trial data (clinical performance data), analytical data, and safety data. Manufacturers must provide robust clinical evidence to demonstrate the performance, safety, and clinical utility of the CDx.

There are a number of other factors that can affect the approval process for CDx in the EU. These factors include:

The availability of data: Both the Notified Body and the EMA will need to have access to data from clinical trials that demonstrate the safety and effectiveness of the CDx.
The complexity of the CDx: The more complex the CDx, the more difficult it will be to assess its safety and effectiveness.
The novelty of the CDx: If the CDx involves new technologies or indications, the EMA and the Notified Body will need to take a more cautious approach to its approval. Different scenarios will play a role on the extent of scrutiny involved, including co-developed CDx scenarios, follow-on CDx, and CDx already on the market under the old IVD directive.

Understanding the EMA Companion Diagnostics Consultation Procedure

The consultation procedure is initiated by the notified body when it receives an application from a CDx manufacturer. The medicinal product involved could be a medicine already authorised for marketing in the EU or a medicine undergoing approval. Aligning drug and diagnostic development processes can help to ensure that the results of the clinical trials are accurate and reliable, and that the medicine is safe and effective when used with the CDx.

Aligning timelines in the drug and diagnostic (CDx) development process can help to ensure that the clinical trials for the medicine are conducted in a way that is consistent with the intended use of the CDx.

Upon application for a CDx IVD approval, the notified body will submit a letter of intent to the EMA, along with a technical dossier that describes the CDx and the medicinal product.

The EMA will then appoint a rapporteur, who will be responsible for reviewing the technical dossier and issuing a scientific opinion on the suitability of the CDx for use with the medicinal product. The rapporteur will also consider the views of any other interested parties, such as the applicant for the medicinal product, the manufacturer of the CDx, and patient groups.

The EMA will provide its scientific opinion on the CDx aspects that relate to the medicine to the notified body. The notified body will then use the EMA’s opinion to make a decision on whether to grant the CE mark to the CDx, in accordance with the regulatory requirements of the in vitro diagnostics regulation (EU IVDR).

EMA procedure timetables play a major role in the success of the consultation and turn around times for responses can be extremely short. Manufacturers should factor this in as they plan for their CDx submissions. There is the possibility to request a pre-submission meeting which will include representatives from Notified Bodies, EMA and could also include the drug manufacturer – this is used strictly to align on procedural and timing considerations (it is not used to provide feedback on study design or the content of the technical documentation).

One of the key documents used in the consultation and submitted by the notified body to the EMA is the SSP (Summary of Safety and Performance). The EMA expects manufacturers to use the SSP template provided in MDCG 2022-9. A lot more detail is expected in the SSP when compared to the information provided in the IFU. For example, detail on concordance studies is needed, particularly for co-developed CDx when different versions of a diagnostic have been used throughout the clinical development program.

MDx CRO: Your Partner in Companion Diagnostics Consultancy

Our companion diagnostics consultancy services encompass every stage of development, approval, and post-market surveillance:

Guidance on IVDR Requirements: In-depth support in understanding and meeting the specific demands of IVDR as they relate to CDx. MDx CRO can help a diagnostics company identify the specific requirements that apply to its CDx. For example, the requirements for a CDx that is intended to assess a patient’s suitability for treatment may be different from the requirements for a CDx that is intended to be used to monitor a patient’s response to treatment.
Preparation for Notified Body Assessment: Tailored strategies for successful assessment of a CDx under the IVDR: Assistance with compiling and submitting the necessary technical documentation and quality related documents.
Providing training to the manufacturer’s staff: MDx CRO can provide training to the manufacturer’s staff on the EMA’s requirements for CDx, as well as the notified body’s assessment process and expectations. This training will help to ensure that the manufacturer’s staff are prepared to answer any notified body questions and increase chances of success.
Stakeholder Communication: Facilitating communication with all relevant parties.
Global Perspective: Navigating international considerations for CDx in multi-country studies.
Post-Market Support: Focused on maintaining the highest standards through ongoing compliance monitoring with IVDR and other regulatory requirements. This includes implementing strong post-market surveillance processes and Post-Market Performance Follow-up (PMPF) evaluations, monitoring the CDx’s performance in real-world clinical settings, tracking and analyzing adverse events related to CDx usage, and conducting ongoing studies to evaluate the long-term impact and effectiveness of the CDx.

Why MDx CRO for Companion Diagnostics IVD Consultancy?

Expertise: Our in-depth knowledge of CDx, IVDR, and EU regulations offers unparalleled support.
Collaboration: Working closely with clients, we tailor our approach to meet specific needs.
Efficiency: Our insights and guidance save valuable time and resources, simplifying complex regulatory pathways.
Commitment: Our dedication to excellence, patient safety, and innovation sets us apart.

Navigating the multifaceted world of companion diagnostics in the EU, with the added complexity of IVDR, requires a dedicated and skilled partner. MDx CRO stands ready to be your guide in this critical journey, ensuring alignment with all regulatory standards. Reach out to explore how our companion diagnostics consultancy can be the key to unlocking your CDx potential in the EU’s dynamic regulatory environment.

Frequently Asked Questions on COmpanion Diagnostics Consultancy

What is a co-developed Companion Diagnostics in the context of EMA consultation?

A co-developed CDx is a device developed alongside a medicinal product for either initial authorization or a change of indication. This can include development during a pivotal clinical trial or a bridging study, with sufficient documentation to ensure performance alignment.

How does a follow-on CDx differ from a co-developed CDx?

A follow-on CDx seeks the same indication as the original CDx but is not developed in parallel with the medicinal product. The follow-on CDx targets the same biomarker but may not be based on the same technology. It should be highly comparable to the original in performance, safety, and effectiveness.

What documentation is required for a follow-on CDx?

Sufficient documentation must be provided for a follow-on CDx to prove that its analytical performance is comparable to the original CDx and that there’s no impact on clinical performance incompatible with the safe and effective use of the medicinal product.

How are devices transitioning from IVDD to IVDR handled?

Devices initially marketed under Directive 98/79/EC (IVDD) that transition to IVDR fall under the co-developed or follow-on scenarios, depending on how they were initially developed.

Is it possible to proceed with a single CDx consultation procedure for multiple authorized medicinal products and indications?

Yes, if a device’s intended purpose includes several authorized medicinal products and indications, it’s recommended to proceed with one single CDx consultation procedure. All concerned medicinal products should be listed in the intention to submit a letter by the Notified Body and in the application form.

Written by:

Carlos Galamba

CEO

Senior regulatory leader and former BSI IVDR reviewer with deep experience in CE marking high-risk IVDs, companion diagnostics, and IVDR implementation.

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