Navigating the IVDR CDx Certification Pathway

February 3, 2026

The evolving landscape of Companion Diagnostics (CDx) introduces complexities in regulatory and certification processes. Engaging in IVDR Companion Diagnostic Consulting is essential to ensure a streamlined and compliant journey.

Deciphering Regulatory Nuances: US vs. EU

Historically, CDx devices in the EU were self-certified under the IVDD. A CDx manufacturer may have had experience with the FDA but the regulatory process in the EU is only now emerging.

The EU IVDR defines a CDx as a device which is essential for the safe and effective use of a corresponding medicinal product to identify, before and/or during treatment:

Patients who are most likely to benefit from the corresponding medicinal product
Patients likely to be at increased risk of serious adverse reaction as a result of treatment with a corresponding medicinal product

The FDA’s definition is similar but extends to devices used for “monitoring treatment responses with a particular therapeutic product”. Unlike in the US such devices are not considered companion diagnostics in the EU. Furthermore, the FDA acknowledges a category of devices termed complementary diagnostics. These diagnostics are characterized as tests that pinpoint a group of patients, identified by specific biomarkers, who respond well to a drug. While they assist in evaluating the risk-benefit ratio for individual patients, they aren’t mandatory for drug administration. Within the IVDR framework, complementary diagnostics aren’t explicitly detailed, nor do they have specific prerequisites for CE certification

These nuances are key for any CDx regulatory strategy and for the planning of CDx clinical trials. A specialized IVDR CDx consulting company like MDx CRO can help diagnostic companies and their pharma partners navigate global differences and ensure CDx regulatory compliance.

The EMA Consultation Process

EMA’s guidance stands as a pivotal component in IVDR Companion Diagnostic Consulting. The EMA CDx Assessment Report Template, publicly available, provides a comprehensive blueprint. It is a great source of information for the expectations in CDx submission content, particularly useful for when drafting SSPs and IFUs.

MDx CRO published a comprehensive guide to the CDx consultation process.

The process encompasses:

Declaration of intent.
EMA Rapporteur appointment.
Optional, but highly recommended, pre-submission meeting.
Application submission.
Interactive Q&A phases.
EMA’s final verdict.

Crafting of SSP & IFU with Detail

For successful IVDR CDx certification, the SSP and IFU documents should be meticulously detailed as they are the 2 key documents used during the EMA consultation process.

Diagnostic manufacturers should ensure they include:

Emphasis on scientific validity of the biomarker
Comprehensive detail on performance evaluation, study design descriptions, encompassing both analytical and clinical performance.
Insight into clinical data, detail on device modifications during or after the clinical performance study, and associated impacts, rationale for cut-off point selection and more.

A deep dive into the risk-benefit analysis is pivotal, concentrating on major residual risks and device limitations.

Time Considerations for IVDR CDx Certification

The certification process for CDx under IVDR is extensive. From the initial 3-month EMA notification to the concluding recommendation, the timeline can span 8-18 months. Such extended durations underline the criticality of early preparations. Engaging early with a specialized CDx consulting company can help avoid surprises and streamline the CDx certification journey.

The expertise offered by the notified body can significantly enrich IVDR Companion Diagnostic certification. Early engagements, prior to document submissions, can provide clarity, ensuring alignment with EMA requirements.

Selecting your IVDR CDx Consulting partner

MDx CRO has published a deep dive into the crucial factors to bear in mind when picking an IVD consultant.

In the dynamic realm of CDx, efficient navigation is paramount. If you’re seeking specialized insights into IVDR certification, explore our IVD services. At MDx CRO, our experts offers tailored IVDR Companion Diagnostic Consulting, ensuring optimal integration of CDx within the regulatory framework.

Contact our team today to discuss your CDx product needs!

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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Regulatory Compliance for Dental Products

IVDR Lab Readiness: Step-by-Step Transition Checklist

Regulatory Compliance for Dental Products

February 3, 2026

A Practical Guide for Medical Device Manufacturers

Regulatory compliance for dental products has become far more complex over the past decade. What was once a relatively straightforward pathway is now a demanding, lifecycle‑driven process that requires robust technical and clinical evidence, structured post‑market surveillance, and ongoing regulatory oversight.

For manufacturers bringing dental products to market, especially under the EU Medical Device Regulation (MDR), compliance is no longer a single milestone. It is a continuous obligation that influences product design, technical documentation, clinical evidence, and post‑market performance activities throughout the entire lifecycle.

From our experience as a consulting company supporting medical device manufacturers, dental products often lie at the crossroads of material science, clinical performance, and stringent regulatory requirements. This combination makes regulatory compliance both critical and increasingly challenging for manufacturers aiming to achieve and maintain market access.

What Regulatory Compliance Means for Dental Products

Dental products as dental medical devices

Many dental products are legally classified as medical devices, even when they are commonly perceived as materials or components. Items such as dental alloys, implantable components, restorative materials, and certain software‑driven solutions fall under medical device regulations when intended for a medical purpose.

This classification carries specific regulatory obligations for manufacturers, whether the product is used directly by clinicians or indirectly through dental laboratories.

Responsibility across the dental product lifecycle

Regulatory compliance extends far beyond initial approval. As is the case for other medical device manufacturers, dental manufacturers remain responsible for:

Defining and maintaining the intended purpose
Ensuring ongoing safety and performance
Monitoring post-market data
Updating documentation as evidence evolves

Importantly, many compliance failures do not arise from missing documents, but from misalignments and inconsistencies across lifecycle activities. Maintaining clear linkage between purpose, evidence, and post-market insights is essential for demonstrating a coherent and compliant lifecycle strategy. When these key elements stay aligned, manufacturers strengthen regulatory trust, reduce risk, and support smoother long-term market access. This principle applies equally to dental medical devices and to all other medical devices, as it is transversal across the sector.

Why dental products face increased scrutiny

Dental devices frequently involve:

Implantable or long-term contact materials
Complex alloy compositions
Large legacy portfolios originally certified under previous regulations

These features introduce specific regulatory expectations. Implantable and long-term contact materials require robust biocompatibility assessments and long-term safety evaluations. Additionally, complex alloys may require chemical and toxicological evaluations to ensure that all constituent materials meet biological safety standards. Finally, legacy products, previously certified under less stringent requirements, must now be re-evaluated using updated evidence to demonstrate continued safety and performance under current frameworks.

Together, these factors increase expectations for clinical evidence, biological safety, and post-market surveillance, leading to closer regulatory scrutiny and more rigorous conformity assessment processes.

Which Regulations Apply to Dental Medical Devices?

European Union: EU MDR

In the European Union (EU), medical devices are governed by Regulation (EU) 2017/745 (MDR). Compared to the former Medical Device Directives (MDD/AIMDD), MDR introduces:

Stronger clinical evidence requirements
Enhanced post-market surveillance obligations
Increased scrutiny from Notified Bodies
Clearer expectations for technical documentation consistency

Manufacturers of dental devices are therefore required to fulfil these additional requirements to ensure the device is compliant with EU market requirements.

United Kingdom: UK MDR and UKCA Marking

In the United Kingdom (UK), medical devices are regulated under the UK Medical Devices Regulations 2002 (as amended), with oversight by the Medicines and Healthcare products Regulatory Agency (MHRA). Following Brexit, the UK has established an independent regulatory framework, while maintaining transitional recognition of CE marking in Great Britain.

Compared with the EU MDR, the UK framework introduces a parallel but distinct pathway, characterized by:

The progressive transition from CE marking to UKCA marking for Great Britain
UK-specific registration requirements with the MHRA
Potential divergence in timelines, conformity assessment routes, and regulatory interactions
The need to monitor evolving UK legislation as the framework continues to develop

Manufacturers of dental devices must therefore define a clear UK regulatory strategy, ensuring that UKCA requirements (and transitional CE provisions, where applicable) are properly addressed, while maintaining alignment with EU documentation and lifecycle activities to the extent possible.

United States of America: FDA

The United States can also be an attractive market for dental devices. For manufacturers wishing to operate beyond Europe, dental product compliance must align with FDA expectations or other international frameworks. While this article focuses on EU MDR, a global regulatory strategy should aim for evidence reuse and lifecycle consistency across jurisdictions.

Maintaining a broad perspective on regulatory expectations in different markets enables more efficient submissions at various time points, minimizing duplicated effort and ensuring smoother pathways to global market access.

Regulatory Classification of Dental Products in EU

How to determine classification

Under MDR, dental devices are classified based on:

Intended purpose
Duration of contact
Invasiveness
Implantable status

Many dental materials and alloys are classified as higher risk than expected, particularly for implantable or long-term applications. Understanding these rules early helps ensure accurate classification.

Why classification drives EU regulatory strategy

Classification decisions affect:

Conformity assessment routes
Clinical evidence depth
Post-market obligations
Notified Body involvement

Misclassification early in development often leads to costly rework later, particularly once technical documentation has been developed or regulatory submissions have begun. Manufacturers must also avoid making changes to the product or its intended purpose after commercialization that could alter its classification and trigger additional regulatory requirements. Establishing the correct classification from the outset and maintaining alignment throughout the lifecycle are essential to a smooth, predictable regulatory pathway.

Learning from Real-World MDR Transitions in Dental Products

Across MDR transition projects involving complex dental portfolios, one lesson consistently emerges: regulatory compliance succeeds when evidence, processes, and documentation are aligned from end to end.

Large dental product families require structured execution, clear ownership, and realistic timelines. Compliance is less about individual documents and more about how well the regulatory system functions as a whole.

If you want to see how these principles apply in practice, you can read our full case study on an MDR transition for dental products.

Read the full case study here

Core Regulatory Requirements for MDR Compliance of Dental Products

Technical documentation and conformity assessment

Regulatory compliance for dental products starts with technical documentation that clearly and consistently supports the device’s safety and performance. Under MDR, this documentation is reviewed as a single, connected system rather than as separate files.

Manufacturers must demonstrate that the device is well defined, risks are properly controlled, and clinical and biological evidence support the intended use. In practice, regulatory findings often arise not because documents are missing, but because different parts of the technical file are not fully aligned.

Clinical evaluation

Clinical evaluation must show that the dental device performs as intended and remains safe throughout its lifecycle. This assessment is typically based on a combination of clinical data, relevant scientific literature, and post-market evidence where available.

For dental devices, regulators closely scrutinize whether clinical claims align with the intended purpose and the conclusions from risk management activities. Any inconsistency between these elements is one of the most frequent causes of Notified Body questions during technical documentation review. Ensuring consistency across intended purpose, clinical evidence and risk conclusions is essential for a smooth clinical evaluation process.

Biological evaluation and material safety

Biological evaluation is particularly important for dental materials that come into prolonged or permanent contact with the body. Manufacturers are expected to follow a structured, risk-based approach that justifies testing, addresses worst-case configurations, and integrates toxicological considerations where relevant.

Weak biological rationales or conclusions that are not reflected in risk management and labelling are frequent sources of non-conformities. A coherent and well documented evaluation is therefore essential to demonstrate material safety and regulatory compliance.

Risk management and traceability

Risk management under MDR is a continuous process, not a one-time activity. Regulators increasingly expect clear traceability between identified hazards, risk control measures, supporting clinical and biological evidence, and the information provided to users.

Consistency over time is critical. Risk management conclusions must remain aligned with clinical evaluation updates and post-market data as new information becomes available.

Labelling and instructions for use (IFUs)

Labelling and IFUs must accurately reflect the device’s intended use, residual risks, contraindications, and safety-related information. Inconsistencies between labelling and technical documentation are a common reason for regulatory findings.

Under MDR, labelling is assessed as a direct extension of the manufacturer’s risk and clinical conclusions, not as a standalone deliverable. Correct and well-structure labelling and IFU is particularly important because it is often the only information the end user will directly interact with. Clear and accurate instructions reduce the likelihood of misuse, improve clinical outcomes, and contribute to patient safety.

Post-Market Obligations for Dental Medical Devices under MDR

Post-Market Surveillance (PMS)

PMS systems must actively collect and analyse real-world data to ensure devices continue to perform safely and effectively once in clinical use. This includes:

Complaint handling
Trend analysis and early detection of potential risks
Vigilance reporting
Periodic safety updates

For dental devices, many of which are used repeatedly and placed in the oral cavity for long durations, post-market provides essential insight into performance across different clinical environments and users.

PMCF and PSUR

Depending on classification and associated risk, manufacturers may be required to implement:

Post-Market Clinical Follow-up (PMCF)
Periodic Safety Update Reports (PSUR)

PMCF is especially relevant in dentistry, where varied patient populations and technique-sensitive procedures can impact long-term outcomes. PSURs ensure that these insights are systemically gathered, assessed and fed back into the technical documentation.

Why Post-Market Data matters beyond compliance

Post-market activities are not simply regulatory obligations. They play a strategic and clinical role, helping manufacturers:

Identify how products perform in diverse real-world dental practices
Detect early signs of wear, degradation or unexpected biological responses
Refine IFUs, contraindications or warnings based on real-use scenarios
Support claims of durability, reliability, and biocompatibility with ongoing evidence
Strengthen competitiveness by demonstrating proven, long-term performance

Post-market data is therefore not optional and is central to demonstrating ongoing compliance and to maintaining clinical confidence, improving product quality, and supporting future innovation.

Common MDR Regulatory Compliance Challenges for Dental Products

Legacy devices and MDR transitions

Many dental products on the market today were originally certified decades ago, under earlier regulatory frameworks. Although the MDR entered into full application in 2021, transition periods extend to 2028 (depending on device classification). For legacy devices, a structured gap assessment is essential to identify missing requirements or outdated evidence. Transitioning these products to MDR often reveals gaps in:

Clinical evidence
PMS systems
Biological evaluation rationale
Consistency and traceability across technical documentation

Because many legacy dental products were introduced before modern evidence expectations existed, manufacturers often face significant redevelopment of foundational documentation. Early planning is critical to avoid bottlenecks as MDR deadlines approach.

Portfolio-level complexity

Manufacturers of dental devices typically manage large and diverse portfolios, often with hundreds of variants differing in materials, shade, formulation, packaging or indications. This scale creates a substantial challenge when aligning all products with MDR requirements. To maintain control and ensure all technical documentation is complete and updated, manufacturers require:

Structured regulatory frameworks that define consistent expectations
Harmonised documentation strategies that minimise duplication of work across similar devices
Scalable and robust post-market systems capable of handling extensive product families

Without a systematic, portfolio-level approach, MDR compliance efforts can become fragmented and inefficient. In many cases, non-conformities arise from a lack of strategic coordination across product lines.

Notified Body expectations

Notified Bodies evaluate more than simply the existence of documentation. They assess how effectively manufacturers control their devices throughout the entire lifecycle. Depending on the classification of the dental device, the involvement of a Notified Body can be required for its initial certification, ongoing surveillance, and continued market access. As such, manufacturers must therefore be prepared for both announced and unannounced audits. Maintaining an “audit-ready” state requires:

Evidence coherence, ensuring clinical, biological, risk and labelling conclusions fully align
Lifecycle thinking, with post-market data and risk updates continuously feeding into the technical file
Demonstrated control, not just document availability, meaning systems, processes and records clearly show that compliance is maintained

Ultimately, maintaining this level of operational readiness demonstrates that the manufacturer is in continuous control of product quality and regulatory compliance. This proactive posture not only supports smoother audits but also builds long-term confidence with Notified Bodies. It signals that the manufacturer can reliably uphold MDR expectations throughout the entire lifecycle, ensuring stable and sustained market access.

The Role of MDx in Dental Product Regulatory Compliance

MDx supporting Manufacturers

Manufacturers typically engage MDx when:

Internal teams need execution support
Portfolios are large or complex
Timelines are constrained
Notified Body interactions intensify

MDx provides specialized regulatory expertise and operational capacity, helping manufacturers manage high workloads, accelerate progress, and confidently navigate regulatory expectations.

Execution vs. advisory support

For many manufacturers, advisory guidance alone is not sufficient to move projects forward efficiently. Effective MDx support combines strategic insight with hands-on execution, ensuring:

Development of compliant and high-quality documentation
Evidence generation and alignment across clinical, regulatory and quality domains
Practical experience navigating audits and regulatory reviews

This integrated approach strengthens submissions, accelerates timelines, and reduces pressure on internal teams. As a result, manufacturers can focus on additional projects, key milestones, and ongoing product development without compromising regulatory progress.

Supporting market access

Through close collaboration between MDx and manufacturers, companies can more effectively:

Reduce regulatory risk, by ensuring requirements are met with robust and compliant evidence
Accelerate conformity assessment through well-prepared documentation and proactive regulatory strategy
Maintain long-term compliance across the product lifecycle, from initial submission to post-market activities

Key Takeaways: Placing Dental Medical Devices on the Market

Manufacturers that treat compliance as a strategic function (supported by the right expertise) are better positioned to place and maintain their products on the market without unnecessary delays or regulatory setbacks.

Regulatory compliance for dental products is:

A lifecycle commitment, not a one-off project
Heavily dependent on consistency and traceability
Increasingly scrutinised under MDR

If you are preparing to bring a dental or medical device to market and require execution‑level MDx support, our team partners directly with manufacturers to provide comprehensive, end‑to‑end regulatory compliance services.

Let’s talk about your project, contact us.

Written by:

Andre Moreira

Regulatory Director, Medtech

Senior quality & regulatory expert, ISO 13485/MDR/IVDR auditor with expertise in CE marking MDs/IVDs, incl. dental, implantables, drug delivery, genomic tests, & MDR/IVDR implementation.

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January 28, 2026

The IVDR Shift and What It Means for Clinical Laboratories

The in Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 came into force on 26 May 2022, representing a paradigm shift for diagnostic testing in Europe. Its purpose is clear: ensure safety, traceability, and performance of all in vitro diagnostic devices (IVDs). Unlike its predecessor, the IVDD (98/79/EC), the IVDR applies far-reaching obligations not only to manufacturers but also to clinical laboratories that develop and use their own in-house IVDs (IH-IVDs).

A cornerstone of this new landscape is Article 5(5), which sets conditions under which health institutions may continue manufacturing and using in-house devices without CE marking. While this exemption acknowledges the clinical need for tailored diagnostics, it also imposes new responsibilities.

This blog provides a step-by-step readiness checklist for laboratories to guide you through the transition.

Step 1: Do You Know What Counts as an In-House IVD?

What exactly is an in-house IVD under the IVDR?

An in-house IVD (sometimes called a laboratory-developed test or LDT) is any in vitro diagnostic device manufactured and used only within a health institution, not supplied to another legal entity, and not manufactured on an industrial scale

Examples include:

PCR assays where the lab develops its own probes.
Custom-developed software tools for diagnostic interpretation.

Excluded are:

General laboratory supplies.
RUO (research use only) products – unless repurposed for diagnostic use. If an RUO product is used for diagnostic purposes (i.e., results are communicated to the patient for medical decision-making), it ceases to be RUO and must comply with IVDR Article 5(5), thereby becoming subject to the same obligations as an in-house IVD/LDT.
Commercially available CE-marked IVDs (which must be purchased and used as intended) – unless it is modified, combined or used outside it’s intended purpose.

Takeaway:

You must determine whether you are using an in-house IVD. If you are modifying, combining, or using CE-marked diagnostic tests outside their intended purpose, or if you are repurposing RUO products for diagnostic use, you must ensure compliance with Article 5(5).

Step 2: Is Your Laboratory Recognized as a Health Institution?

Who is entitled to the Article 5(5) exemption?

Only health institutions may use in-house IVDs. According to the IVDR, a health institution is an organization whose primary purpose is patient care or public health. This includes:

Hospitals
Clinical laboratories
Public health institutes

Importantly, the recognition of health institutions may depend on national legislation. For instance, some countries require formal registration or accreditation to benefit from Article 5(5).

Takeaway:

Always check your national laws to confirm whether your laboratory qualifies as a “health institution” and whether additional national restrictions or obligations apply.

Step 3: CE-Marked or In-House? Make a Strategic Choice

Should your lab buy CE-marked tests or continue with in-house ones?

Under IVDR, labs face a strategic decision:

Purchase CE-marked IVDs: These carry regulatory assurance but may not always exist for niche diagnostic needs, and market withdrawals could limit supply.
Develop and use in-house IVDs: Allowed under Article 5(5) if your lab demonstrates compliance with conditions (e.g., GSPR, QMS, technical documentation).

From 31 December 2030, labs must justify why an equivalent CE-marked device is not suitable if they want to continue using their in-house test (article 5(5)(g))

Takeaway:

Begin analyzing your portfolio now. Which tests could be replaced by CE-IVDs, and which must remain in-house due to clinical need?

Step 4: Do You Comply with General Safety and Performance Requirements (GSPR)?

What technical documentation requirements already apply?

Since 26 May 2022, all in-house devices must comply with Annex I of the IVDR (GSPR). This includes:

Risk management system covering patient, user, and use error risks.
Performance evaluation based on scientific validity, analytical performance, and clinical performance.
Traceability and identification (lot numbers, production dates).
Appropriate instructions for use and safety information

Takeaway:

Treat your in-house tests with the same rigor as CE-marked devices. Maintain documentation to always prove compliance with the GSPRs.

Step 5: Have You Implemented an Appropriate QMS?

What does IVDR require for quality management when operating under article 5.5?

Since 26 May 2024, labs must manufacture and use in-house devices under an appropriate Quality Management System (QMS). For in-house IVDs, this generally means compliance with EN ISO 15189 or equivalent national provisions

However, note:

ISO 15189 covers quality in medical laboratories but not necessarily manufacturing processes.
Therefore, supplement with elements of ISO 13485 for design and production control.
In addition, laboratories must address the QMS requirements described in Article 10(8) IVDR, which outline the minimal aspects of a system covering risk management, manufacturing documentation, monitoring, corrective actions, and communication with authorities.

Takeaway:

Expand your QMS to cover risk management, manufacturing documentation, monitoring, and corrective actions, and the additional QMS obligations set out in Article 10 IVDR. Note that ISO 15189 alone is not sufficient; relevant elements of design and manufacturing from ISO 13485 must also be considered, as the IVDR introduces further QMS requirements that must be fulfilled.

Step 6: Can You Provide a Public Declaration?

Do labs need to publish information about their in-house devices?

Article 5(5)(f) IVDR requires health institutions to draw up and make publicly available a declaration for each in-house device. This obligation has applied since 26 May 2024, following the end of the initial transition period.

What must the declaration contain? At minimum:

Name and address of the health institution manufacturing the device.
Details necessary to identify the device (e.g., designation, type, internal code).
A declaration of compliance with Annex I (GSPR), or where full compliance is not possible, a reasoned justification explaining the deviations.
Confirmation that the device is manufactured under an appropriate QMS.

This declaration must be kept up to date and made easily accessible, typically via the laboratory or hospital’s website This transparency ensures accountability and facilitates oversight.

Takeaway:

Prepare standardized declarations for each in-house device. A practical tool exists: the IVDR Taskforce Guidance on LDTs (2020) provides a template (Appendix B) for the declaration that can be directly adapted by laboratories.

Step 7: Are You Ready for Competent Authority Oversight?

What role do regulators play?

Competent authorities may request documentation or even audit your lab to verify compliance. Labs must be prepared to show:

Design, manufacturing, and performance documentation of their in-house devices.
Clinical justification for developing or using the test instead of a CE-marked alternative.
Ongoing performance review and vigilance records, including corrective actions and monitoring of clinical use.
Evidence of an appropriate Quality Management System (QMS), as required since 26 May 2024.

The degree of oversight varies across Member States. For example, Belgium and Ireland already operate registration portals where laboratories must register their in-house tests. In other countries, legislation is still under development (Spain) or practices remain vague.

Takeaway:

Anticipate audits. Keep a compliance file for each in-house IVD.

Step 8: How Will You Justify Non-Equivalence? (2030 Requirement)

What happens in 2030?

From 31 December 2030, labs must justify why the specific needs of their target patient group cannot be met by a CE-marked device – Article 5(5)(g).

This justification may be based on:

Technical aspects (e.g., higher sensitivity).
Biological aspects (e.g., pediatric vs adult reference ranges).
Clinical needs (e.g., unmet diagnostic gaps).

Takeaway:

Start now by mapping your portfolio and identifying tests likely to face challenges in proving non-equivalence.

Step 9: Do You Have the Resources?

Why are many labs struggling?

Challenges highlighted in recent analyses include:

Lack of dedicated regulatory staff.
Limited time and budget for documentation.
Unfamiliarity with regulatory terminology.

Takeaway:

Seek structured support, whether through consultants, digital tools, or peer networks, to avoid non-compliance.

Step 10: Checklist. Is Your Lab Ready?

Step 1: Perform a GAP Assessment

Map your current situation: List all in-house IVDs and how they are used in your lab.
Check national status: Verify if your institution qualifies as a “health institution” under national law, and review whether national legislation imposes additional obligations such as mandatory QMS accreditation (e.g., ISO 15189), registration of in-house IVDs with competent authorities, or other reporting requirements that go beyond the IVDR.
Compare requirements vs. practice: Review the IVDR Article 5(5) obligations and identify where your lab already complies (e.g., risk management, traceability) and where gaps exist (e.g., QMS documentation, technical documentation).
Prioritize risks: Highlight critical areas (such as missing QMS procedures or incomplete Annex I documentation) that could block compliance in an inspection.

Step 2 – Take Action to Close the Gaps

Strategic choice: Decide whether to replace tests with CE-IVDs or maintain in-house versions. Document the rationale.
Annex I (GSPR): Ensure all in-house IVDs comply with General Safety and Performance Requirements (effective since 26 May 2022).
Quality Management System: Implement or update your QMS to align with ISO 15189, supplemented with elements from ISO 13485 and Article 10(8) IVDR.
Compliance documentation & oversight readiness: Compile and maintain a compliance file for each in-house IVD, including full technical documentation (design, manufacturing, risk management, and performance evaluation). Ensure these files are audit-read and can be provided upon request by competent authorities.
Vigilance & corrective actions: Set up procedures for monitoring performance, handling incidents, and implementing corrective/preventive measures.
Public declaration: Draft and publish a declaration for each in-house device (mandatory since 26 May 2024). Use available templates from guidance.
2030 justification: Start documenting why no equivalent CE-IVD meets the needs of your patient population to support continued in-house use after 31 December 2030.

Closing Thoughts

The IVDR sets high expectations for laboratory-developed in-house IVDs, transforming informal diagnostic practices into rigorously controlled processes. While compliance requires effort, resources, and cultural change, it also strengthens quality, safety, and patient trust. For laboratories, the transition is not optional, it is an opportunity to embed regulatory excellence into daily operations and secure the future of innovative diagnostics. Are you ready for the IVDR transition? Start today with a gap analysis, QMS reinforcement, and documentation plan. The earlier you act, the smoother your path to compliance will be.

At MDx CRO, we specialize in helping clinical laboratories navigate the IVDR, from gap assessments to QMS implementation and technical documentation. We support laboratories in demonstrating compliance with Article 5(5) for in-house IVDs by assisting with:

Gap assessments: Mapping all in-house IVDs, comparing current practice with IVDR Article 5(5) requirements, and identifying compliance gaps.
QMS alignment: Extending ISO 15189-based systems with manufacturing and design elements from ISO 13485, plus additional QMS obligations under IVDR.
Technical documentation: Preparing complete compliance files per device.
Public declarations: Drafting and publishing Article 5(5)(f) declarations using recognized templates, ensuring accessibility and consistency.
Regulatory readiness: Preparing for competent authority oversight, including audits and requests for documentation.
Strategic portfolio decisions: Advising whether to replace tests with CE-IVDs or justify continued in-house use, including preparing 2030 equivalence justifications.
Vigilance systems: Setting up monitoring, incident reporting, and corrective/preventive actions in line with IVDR obligations.

Our team knows the pitfalls and the solutions. Let us support you in achieving full compliance. Contact us today to discuss how we can help.

Written by:

Hugo Leis, PhD

Training & Quality Manager

Quality & Training Manager and Senior IVDR consultant with expertise in CE marking, Clinical Laboratories, SaMD, Precision Medicine, Quality Assurance, and academic lecturing.

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IVD Clinical Trials: The Do’s and Don’ts

January 26, 2026

What are some of the most important things you’ll need to know for IVD clinical trials? Continue reading to learn more.

In-vitro diagnostics (IVD) are tests performed on biological samples, such as blood or tissue, to diagnose or monitor medical conditions. IVD devices are coming out with new and improved features leading to more accurate results than ever.

According to a report by Grand View Research, the global IVD market is expected to reach $113.38 billion by 2030, with increasing demand for early disease detection, personalized medicine, and technological advancements driving growth.

However, developing and bringing an IVD device to market often requires extensive clinical trials (or IVD clinical performance studies as referred to in the EU IVDR 2017/746). They should be designed to demonstrate sufficient clinical performance and compliance with the general safety and performance requirements (GSPRs).

Clinical trials play a crucial role in the development and approval of IVD products, but navigating the complex regulatory landscape can be a challenge.

So here we will explore some do’s and don’ts of IVD clinical trials, focusing on key considerations for study design, recruitment, data management, and regulatory compliance. This will lead to better market success for the product. Keep reading to know more.

IVD Clinical Trials: Do’s

Here is what you must consider doing when conducting clinical trials.

1. Develop A Comprehensive Clinical Performance Study Plan

Developing a comprehensive clinical performance study plan is critical to the success of IVD clinical trials. The plan should include the trial’s objectives, design, endpoints, sample size, inclusion/exclusion criteria, and statistical analysis plan. The plan should also indicate the study design type such as observational or interventional and adhere to regulatory requirements.

There should also be a detailed timeline, budget, and risk management plan. This will ensure that the trial is conducted efficiently, safely, and with the necessary regulatory compliance.

2. Prioritize Patient Safety

Patient or participant safety should be the top priority in any clinical study, including IVD clinical performance study. The Clinical Performance Study Plan should include measures to ensure patient safety, such as monitoring adverse events and implementing safety stopping rules.

Patients should be informed of potential risks and benefits before participating in the trial, and their consent should be obtained in accordance with regulatory requirements.

3. Utilize Validated Assays And Methods

Validated assays and methods are essential to ensure the accuracy and reliability of IVD clinical trials. Assays and methods should be validated in accordance with regulatory requirements, and any modifications to validated methods should be properly documented and justified. In essence, the IVDs utilized in clinical performance studies should accurately represent the final product as it is intended for commercial distribution.

Failure to use validated assays and methods can result in inaccurate or unreliable results and will not be accepted by regulatory bodies.

4. Maintain Good Communication With Regulatory Agencies

Maintaining good communication with regulatory agencies throughout the clinical trial process can help ensure the trial’s success. Certain clinical performance studies require an application for authorization to be submitted to the competent authority.

The member state(s) responsible for the authorization may assess several factors, including the statistical approach, study design, sample size, selected comparators, choice of endpoints and others as per article 67 of the EU IVDR.

Unlike in the US, regulatory agencies in the EU (including notified bodies) do not provide guidance on trial design. However, for companion diagnostics there is the possibility for a pre-submission meeting with the European Medicines Agency (EMA) to align on timelines, which is particularly important in co-development scenarios.

Manufacturers should also be transparent with regulatory agencies regarding any issues that arise during the IVDR Clinical Performance Study, such as adverse events or protocol deviations, including substantial modifications.

5. Include Biostatistics

The involvement of biostatistics is pivotal in the design of clinical trials as it aids in determining the trial’s framework, choosing the appropriate sample size, selection of randomization and blinding methods, and data analysis.

You must involve biostatisticians in all stages of a clinical trial, from protocol development to final analysis. Biostatisticians will ensure that the study design is robust, the data collection methods are valid and reliable, and the results are statistically sound.

Put simply, biostatistics helps researchers make accurate inferences from the data and draw valid conclusions.

6. Use Qualified Personnel

The success of IVD clinical trials depends on the expertise of the personnel involved. It’s essential to have a team of qualified professionals, including, where appropriate, physicians, researchers, laboratory professionals and support staff, who have the necessary knowledge and experience to conduct the study safely and effectively.

It’s also important to ensure that all personnel are adequately trained in the study protocol and are aware of their responsibilities and obligations.

7. Maintain Accurate And Complete Documentation

Proper documentation is essential to ensure the quality and integrity of the trial data. This includes study reports, case report forms, and other documents related to the trial.

Make sure to have all the required documentation for the study.

8. Ensure Efficient Data Management

Data management starts with the development of a data management plan that outlines how the data will be collected, stored, and analyzed. During the trial, data must be collected accurately, efficiently, and securely.

The data must also be monitored for quality and completeness. After data collection, it must be entered into a secure database and verified for accuracy.

It must then be analyzed and reported in a timely manner. Data management is crucial in clinical trial design because it ensures that the data generated is accurate, reliable, and can be used to draw valid conclusions.

9. Incorporate User Feedback Into Trial Design And Execution

User input can provide valuable insights into the use experience, including ease of use and comprehension of the IVD device and its instructions for use, as well as potential challenges or concerns. In the contemporary world, feedback is crucial. This area is particularly important for IVDs intended for lay-users and should be available in the technical documentation that is submitted to the notified body.

IVD Clinical Trials: Dont’s

Here is what you should completely avoid doing in the case of IVDR Clinical Performance Studies.

1. Don’t Neglect Regulatory Compliance

IVD clinical trials must comply with regulatory requirements from various governing bodies. In the United States, IVD clinical studies must follow guidelines from the Food and Drug Administration (FDA) for investigational device exemption (IDE) studies.

The European Union has similar requirements for IVD clinical trials, but compliance is overseen by various stakeholders. These include competent authorities, responsible for authorizing the conduct of certain performance studies, Notified Bodies (NBs), tasked with assessing IVD conformity and the European Medicines Agency (EMA) which evaluates companion diagnostics to ensure they are suitable to guide the safe and effective use of medicines. Failure to comply with regulatory requirements can result in delays in approval or even rejection of the device.

2. Don’t Overlook Sample Size And Population Selection

Sample size and population selection are critical components of any clinical trial, including IVD clinical performance studies. A sample size that is too small can result in unreliable results, while a sample size that is too large can lead to unnecessary costs and delays.

Population selection is also crucial, as the trial population should represent the intended use population for the device. Failure to consider sample size and population selection can result in inconclusive or biased results.

3. Don’t Ignore Data Integrity

Data integrity is critical to the validity and credibility of the results of IVD clinical trial, with data management being a key component of ISO 20916. Data should be recorded accurately and completely, and any modifications to data should be properly documented and justified.

Data integrity violations can result in the rejection of the device by regulatory agencies and damage the reputation of the manufacturer.

4. Don’t Rush The Clinical Trial Process

Rushing the IVD clinical trial / clinical performance study process can lead to errors, inaccuracies, and potential safety issues. Manufacturers should allow sufficient time for the trial to be conducted properly, including patient recruitment, data collection, and analysis.

Skipping crucial steps or not taking the time needed for each one can result in incomplete or inaccurate data, leading to inconclusive or misleading results.

5. Don’t Cut Corners On Ethics

Ethical considerations should be at the forefront of IVD clinical trials. This includes obtaining informed consent from study participants in the case of interventional or risky studies for example, ensuring that the study protocol is reviewed and approved by an ethics committee, and adhering to strict guidelines for data collection, analysis, and dissemination.

Cutting corners on ethics can not only compromise the integrity of the trial but also have legal and financial consequences.

6. Don’t Over Promise Results

It’s important not to overpromise results or make false claims about the performance of the product being tested. This not only undermines the integrity of the trial but also puts patients at risk.

It’s essential to be transparent about the limitations of the study and provide accurate information about the product’s potential benefits and risks.

7. Don’t Neglect The Potential Impact Of Regulatory Changes

The regulatory landscape for IVDs is constantly evolving, and it is important to stay up to date on changes that may impact trial design or require additional approvals.

Failure to do so could result in delays or even the need to repeat parts of the trial. This can lead to increased cost and lead time. So, stay on top of what’s changing and have a mechanism to quickly adapt it to the process.

Key Takeaways For Successful IVD Clinical Trials in 2023

Conducting successful IVD clinical studies (or IVD clinical performance studies as defined in the EU) in 2023 requires careful planning, execution, and adherence to regulatory guidelines. As the demand for precision medicine and personalized healthcare continues to grow, the importance of IVDs in diagnostics and patient care will only increase. Therefore, it is crucial to conduct robust and reliable clinical trials to ensure the safety and effectiveness of IVDs.

The IVD industry is constantly evolving, and it is important to stay up to date with the latest developments and best practices to ensure success. By embracing innovation, collaboration, and a patient-centric approach, researchers can help bring safe, effective, and innovative IVDs to market.

The process of planning and conducting IVD clinical trials can be daunting and complex. If you find yourself struggling or experiencing a lack of progress during the research process, we are here to assist you. You can contact us at any stage of development.

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MDR and IVDR Targeted Revision

January 16, 2026

What EU Manufacturers Need to Know in 2026

If you build, launch, or maintain medical devices or IVDs in the EU, the MDR/IVDR targeted revision is the most consequential regulatory update since 2017. On 16 December 2025, the European Commission unveiled a proposal to simplify and streamline MDR and IVDR, cutting administrative drag while keeping safety standards intact.

From our side, 40+ consultants supporting manufacturers across the UK, US, Spain, Belgium, Portugal and the wider EU, we’ve already mapped the practical impact by role, class, and portfolio. Our team of experts analyzed the revision and wrote this article, with action steps you can start this quarter.

Download the complete regulatory analysis

Want the article-by-article breakdown, templates (structured NB dialogue, PSUR cadence, Basic UDI-DI timing), and role-based checklists?

The Big Picture: why the EU proposed a targeted revision

The Commission’s objective is simple: reduce burden, improve predictability, and protect innovation, without lowering safety or performance requirements. The move responds to structural bottlenecks (NB capacity, uneven practices, and certification timelines) that have strained SMEs and constrained product availability.

Team insight
In recent NB projects for UK and US manufacturers seeking EU CE, we’ve observed that early, structured NB engagement eliminates avoidable review loops and reduces time-to-decisionespecially for complex portfolios.

What actually changes (and what doesn’t)

The proposal retains MDR/IVDR safety foundations but changes how processes are applied, more proportionate and digital by default. Key areas:

PRRC, certificate validity and risk-based reviews

PRRC: Simplifies qualification requirements; SMEs using an external PRRC no longer need them “permanently and continuously” available—just available.
Certificate validity: The fixed 5-year cycle is removed. Expect risk-based periodic reviews rather than hard recertification clocks.

Team insight
In multi-site recertifications, moving to risk-based reviews lets RA/QA concentrate on signals instead of calendar milestones, our clients expect a significant reduction in PSUR-related rework after sequencing updates with PMS findings.

PSUR & SSCP/SSP: lighter, risk-driven reporting

PSUR: Class IIb/III (update in Year 1 and every 2 years after; Class IIa) only when necessary based on PMS. NB reviews PSURs for high-risk classes during surveillance.
SSCP/SSP: Scope limited to devices under systematic TD assessment; no separate NB validation.

Classification tweaks: software, reusable instruments & more

Expect targeted rule adjustments that lower risk class for certain categories (e.g., some reusable surgical instruments, accessories to active implantables, software) with proportional evidence expectations-details to crystallise via the legislative process.

IVDR Focus: In-house Devices, Studies and Class C/D Impacts

In-house devices (Article 5(5)): More flexibility, including the ability to transfer in-house devices where public health justifies it; removal of the “no equivalent on the market” condition; central labs for clinical trials fall under the in-house exemption.
Performance studies: Routine blood draws no longer need prior authorisation; leftover-specimen companion diagnostic studies drop notification requirements.

Team insight
Early expert-panel advice for Class C/D IVDs has prevented costly re-works in multiple dossiers. The proposal formalises earlier, faster scientific input to use it.

Faster, Clearer Market Access

Structured dialogue with Notified Bodies (and change control plans)

The proposal creates a formal legal basis for structured dialogue pre and post-submission, plus pre-agreed change control plans to reduce surprises. It also distinguishes changes needing notification, approval, or none.

Breakthrough & orphan devices: priority and rolling reviews

New articles define breakthrough and orphan criteria with priority/rolling conformity assessment and expert access; legacy orphan devices may continue beyond transition under conditions.

Regulatory sandboxes for emerging tech

EU or MS-level sandboxes will enable supervised testing and data-generation for novel tech—accelerating de-risking while maintaining safeguards.

Team insight
For AI-enabled diagnostics, a sandbox + early panel advice creates a two-track plan (evidence + regulatory) that keeps development on schedule while aligning with cyber and data obligations.

Going Digital: EUDAMED, UDI and e-Labelling

The revision pushes digital-by-default:

Digital DoC, electronic submissions, NB-manufacturer digital TD, and eIFU for near-patient tests.
Online sales: essential ID and IFU must be available to users.
UDI: Basic UDI-DI reinforced (assign before NB submission where applicable), more public UDI data, proportionality for small volumes/individualised devices, and preferential conditions for SMEs.

Separately, the Commission has signalled the EUDAMED clock and mandatory use in 2026, which amplifies the value of getting your UDI and EUDAMED data house in order now.

The MDR/IVDR targeted revision is a course correction: proportionate requirements, predictable reviews, and a digital backbone—without compromising safety. Manufacturers that act early—codifying structured NB engagement, recalibrating PSURs, and industrialising UDI/EUDAMED—will convert complexity into speed and resilience. Start with the 90-day plan; the rest gets easier.

Download the complete regulatory analysis

Want the article-by-article breakdown, templates (structured NB dialogue, PSUR cadence, Basic UDI-DI timing), and role-based checklists?

FAQ

Does this lower safety standards?

No. The proposal keeps safety intact while simplifying process steps and aligning evidence with risk.

What’s the new PSUR rhythm?

For IIb/III: update in Year 1 then every 2 years; IIa: update when necessary per PMS. NBs review PSURs for certain high-risk classes during surveillance.

What’s “structured dialogue” in practice?

A formal framework to engage NBs before/after submission, with change-control plans and clear differentiation of changes needing notification/approval/none.

What changes for in-house IVDs?

More flexibility, including transfer options and inclusion of central labs for clinical trials within the exemption; removal of the “no equivalent device” clause.

Where does EUDAMED/UDI fit?

Digital submissions, Basic UDI-DI before NB submission (where applicable), and broader public UDI data access; plan for 2026 EUDAMED milestones now.

Ready to transform regulatory complexity into competitive advantage?

Contact MDx today and let us support your journey through the next chapter of MDR and IVDR.

Written by:

Andre Moreira

Regulatory Director, Medtech

Senior quality & regulatory expert, ISO 13485/MDR/IVDR auditor with expertise in CE marking MDs/IVDs, incl. dental, implantables, drug delivery, genomic tests, & MDR/IVDR implementation.

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Performance studies in gene therapy trials: from assay cut-offs to clinical impact

October 31, 2025

In gene therapy, your in-vitro diagnostic (IVD) doesn’t sit on the sidelines—it drives clinical decisions. If a result screens a participant in/out, times dosing, or informs safety management, you’re in IVDR performance study territory with ISO 20916 as the operational backbone. Treat the IVD like a product under evaluation, not a lab tool, and design a study that proves it’s fit for the exact decision your trial needs.

What actually triggers a performance study in gene therapy?

Use the simplest rule of thumb: does the assay influence patient management? If yes, plan for an IVDR Article 58 performance study in parallel with your clinical trial authorization. Typical triggers:

Eligibility/stratification: AAV neutralizing antibody (NAb) or total-antibody (ELISA) results that gate inclusion/exclusion or set a dosing window.
Patient monitoring: Assays that guide timing or continuation (e.g., changes in humoral markers relevant to vector readiness).
CDx trajectory: When the test is essential for safe and effective use, your evidence should be built to scale toward CDx—even if you’re not filing as CDx yet.

Treat these as combined trials (IMP + IVD). Align the performance study application with the drug CTA so approvals move together.

Build the right “assay stack” for AAV programs

Design your assay plan around the decisions your trial must make. In combined trials (IMP + IVD), that usually means separating screening, decision-making, and context/supporting activities—and documenting exactly which assay output drives which action in the CPSP and APR.

1) Screening assays

Purpose: Identify participants who may be eligible for dosing or further evaluation.
Typical methods: Total antibody (ELISA) and/or neutralizing antibody (NAb) assays.
Predefine: intended purpose, the output used for screening, cut-off, QC/controls, and invalid/repeat handling.
Regulatory note: If screening impacts enrollment/timing, it’s within IVDR performance study scope—reflect this in the protocol and dossier.

2) Decision-making assays

Purpose: Provide the result that directly guides patient management (e.g., eligibility for AAV dosing or readiness after a waiting/intervention period).
Typical method: Cell-based NAb assay when the decision depends on functional inhibition of transduction.
Predefine: a validated cut-off and how it’s applied at the decision point; acceptance criteria (controls/repeats), handling of invalid/borderline results, and any repeat-testing logic.

3) Context/supporting assays

Purpose: Provide supporting information (e.g., PCR/NGS for inclusion criteria or other exploratory markers) without driving patient management unless explicitly pre-specified.
Governance: These may be exploratory assays; do not let them influence decisions unless pre-declared.

Designing the CPSP: endpoints that matter (and survive small-N)

Tie endpoints to the decision you must defend. In rare diseases, power is constrained—precision and transparency carry weight.

Primary, decision-linked endpoints (illustrative):

Proportion below cut-off at the dosing/decision point.
Time-to-negativity (post-intervention or natural decline).
Duration of sustained negativity.
Change from baseline in NAb titers.

Key secondaries (analytical + feasibility + safety):

Analytical performance in operations: run-level QC pass rate, invalid/repeat rate, assay deficiencies/deviations.
Feasibility: turnaround time from collection to result, pre-analytical robustness (freeze–thaw, transport windows, matrix effects), stability.
Safety: AEs from sample collection/device use as per IVDR performance study reporting.

Correlative (pre-specified, descriptive):
Relate NAb kinetics to other humoral markers (e.g., total IgG, capsid-specific antibodies) where it clarifies the biology without over-claiming.

When your IVD sample size is constrained by the gene therapy protocol, say so. Set precision targets for agreement or proportions and specify how you’ll treat indeterminates/missing—regulators prefer realistic clarity over decorative p-values.

From LDT to IVDR: documentation that actually wins

Many gene therapy assays start as lab-developed tests or adapted RUO methods. Under IVDR you need an Analytical Performance Report (APR), not just a conventional validation report. The APR:

Maps analytics to intended purpose and clinical decision.
Uses a structured narrative per characteristic: Purpose → Study design → Statistics → Acceptance criteria → Results → Conclusion.
References applicable frameworks (IVDR, ISO, MDCG) and integrates ICH Q2(R2)/Q14 principles within the IVDR lens.
Justifies non-applicable GSPR requirements explicitly instead of hiding them.

What reviewers expect to “see on the page”

Analytical sensitivity: LoD/LoQ with methods, not just point estimates.
Analytical specificity: cross-reactivity, interference, matrix effects—demonstrated, not assumed.
Accuracy (trueness/bias): vs. reference materials/known concentrations across the measuring range.
Precision: repeatability, reproducibility and intermediate precision (operators, days, instruments).
Measuring interval/reportable range: tied to clinical decisions.
Robustness & stability: small-parameter changes; specimen/reagent stability across the actual logistics.
Traceability: metrological traceability to reference materials or SI units wherever feasible.

Bridging without back-tracking

If you migrate platforms or laboratories, pre-declare equivalence boundaries, commutable panels, and the statistical approach before you switch. Link the APR to the Design History File and ultimately to the Performance Evaluation Report to keep evidence audit-ready.

Operational blueprint: lab-centric, ISO 20916–aligned execution

Programs that run smoothly accept a basic truth: lab operations are clinical operations when an assay drives decisions.

Risk-based monitoring (ISO 20916): Prioritize calibration records, control runs, instrument logs, sample accountability, LIMS audit trails, and lab-critical SDV.
Clear RACI across stakeholders: pharma sponsor, diagnostic partner, central lab, CRO(s). Assign a single “owner of truth” for eligibility calls and a documented adjudication path for gray-zone results.
Sample governance: pre-analytical controls (shipping, temperature, freeze–thaw limits), redraw/retest SLAs, and chain-of-custody that survives inspection.
Safety integration: define device-side AE/device-deficiency flows and their handshakes with the IMP SAE process—who reports what, where, when—and hold joint drills before FPI.

Common pitfalls (and the fix)

Copy-pasting a validation report into IVDR—without showing how analytics support the clinical decision.

Fix: Rewrite into an APR aligned to the intended purpose; connect every analytic claim to the use case.

Pretending power exists in tiny cohorts.

Fix: Pre-specify precision not power; make QC-forward primary endpoints; keep clinical associations descriptive.

Letting exploratory assays creep into decision-making ad hoc.

Fix: Lock the assay stack and decision logic in the CPSP; label everything else exploratory.

Underplaying pre-analytical risk.

Fix: Measure it (transport windows, freeze–thaw), set acceptance criteria, and track at run-level.

Ambiguity in roles and safety.

Fix: Publish a RACI and an integrated safety matrix early; rehearse escalations.

Sponsor checklist

Decide early if the assay changes patient management → if yes, plan an IVDR performance study.
Lock claims, cut-offs, and gray zones; write the CPSP to those decisions.
Choose your study model (prospective/retrospective/bridging) to match real sample access and clinical trial needs.
Produce an APR with complete traceability and justified non-applicable requirements.
Stand up lab-centric monitoring (ISO 20916), eTMF rigor, and LIMS auditability.
Align device and drug safety reporting—on paper and in practice.
Embrace small-N: set precision goals, prioritize QC endpoints, and keep associations descriptive.
Think CDx-ready: structure today’s evidence so tomorrow’s filing doesn’t start from zero.

How MDx CRO accelerates combined gene therapy studies

We run the device side of your combined trial end-to-end: strategy, CPSP/APR/PER authorship, submissions, ISO 20916-aligned operations, lab-centric monitoring and SDV, data/biostats, and inspection-ready traceability. We design performance studies that mirror real clinical decisions, so approvals and operations move in lockstep.

Let’s co-design your performance study

Speak with our IVD & gene therapy team

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