IVDR Transition for Precision Medicine: How MDx CRO Enabled a Seamless Portfolio Upgrade

October 1, 2025

Introduction

IVDR transition for precision medicine programs can stall when portfolios span liquid biopsy, RNA-based sequencing, and comprehensive tumor profiling. A leading US-based precision medicine company asked MDx CRO to migrate its oncology diagnostics from self-declared IVDD and FDA pathways to full IVDR certification—without disrupting European market access. This blog shares how we planned the transition, selected the right Notified Body, rebuilt regulatory files, and safeguarded ongoing clinical and CDx development in Europe.

The Challenge

Convert complex files from FDA/IVDD to IVDR. Multiple assay types (liquid biopsy, RNA-seq, tumor profiling) required re-evidence and restructuring under IVDR Annexes.
Select the optimal Notified Body. The client needed a partner capable of reviewing a diverse portfolio efficiently and cost-effectively.
Regulatory documentation lift. We had to redevelop key documents: analytical & clinical performance (including CPS reports), risk and design files, and labeling—while maintaining business continuity.

MDx CRO’s Approach

1) Strategic IVDR roadmap and portfolio triage

We assessed intended purpose, risk class, and evidence gaps for each product, then prioritized quick-win files to protect revenue while scheduling deeper re-verification work for complex assays. This created a clear IVDR transition for precision medicine timeline across the portfolio.

2) Notified Body strategy

Leveraging our knowledge of NB capacity and focus areas, we strategically selected a Notified Body that balanced approval probability, cost, and credibility. Early technical consultations reduced surprises and kept reviews on track.

3) Robust regulatory files

We generated comprehensive IVDR documentation:

Analytical and clinical performance reports, including scientific validity and performance evaluation reports
Risk management aligned to Annex I GSPRs
Design and development files with clear traceability
Usability and labeling aligned with intended purpose and user context

4) Operational partnership and sponsor duties

The client expanded our role into delegated sponsor responsibilities for clinical studies. We served as EU Legal Representative, oversaw clinical operations, and implemented streamlined processes for biomarker and CDx study submissions across Europe.

Results

Successful IVDR transition for priority diagnostics with uninterrupted market access in Europe.
Competitive advantage: stronger operational readiness helped the client attract pharma partners for clinical trial biomarker testing and CDx development.
Ongoing partnership: MDx CRO manages clinical studies, maintains sponsor duties, and continues the portfolio-wide IVDR journey.

Client Testimonial

“Working with MDx’s Precision Medicine Team has been a pleasure. As a U.S.-based company operating in Europe, I consider them our EU extension. Their expertise and responsiveness keep us ahead in a dynamic market, and the consistency of their delivery has shaped our current and future plans.”

Why This Matters

IVDR raises expectations for evidence, documentation, and lifecycle controls—especially for precision medicine diagnostics. Success requires portfolio triage, NB strategy, and regulatory files that stand up to scrutiny while your teams continue running trials and supporting pharma partnerships. MDx CRO brings integrated regulatory, clinical, and diagnostic know-how to keep your transition moving.

Call to Action

Planning an IVDR transition for precision medicine diagnostics? Let’s protect your market access, cut RFI cycles, and ready your files for Notified Body review.

Talk to MDx CRO

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Navigating IVDR for NGS Assays: Challenges and Solutions with MDx CRO

September 28, 2025

Next-Generation Sequencing (NGS) has revolutionized molecular diagnostics by enabling simultaneous analysis of hundreds or thousands of genes across diverse clinical applications. These include germline testing for hereditary disorders, somatic mutation profiling in oncology, infectious disease characterization, and transcriptomic gene expression analysis.

A particularly impactful advancement is liquid-biopsy NGS, which allows non-invasive detection of tumor-derived nucleic acids—such as circulating tumor DNA (ctDNA) or RNA—from blood or other bodily fluids. This method now supports cancer screening, minimal residual disease monitoring, and therapy stratification.

NGS also powers Comprehensive Genomic Profiling (CGP). These assays assess a wide spectrum of biomarkers—single nucleotide variants (SNVs), insertions and deletions (indels), copy number alterations (CNAs), copy number losses (CNLs), gene fusions, and splicing events—across large panels in a single run. Many workflows also integrate microsatellite instability (MSI) and tumor mutational burden (TMB).

Assays can range from targeted panels to whole exome sequencing (WES) or whole genome sequencing (WGS). Each format carries unique validation needs and bioinformatics requirements. The mix of technologies, analytes, sample types (e.g., blood, plasma, FFPE, cfDNA, RNA), and clinical contexts increases regulatory complexity.

Under the EU In Vitro Diagnostic Regulation (IVDR; EU 2017/746), you must define each intended use clearly and support it with comprehensive evidence of scientific validity, analytical performance, and clinical performance. That requirement calls for a holistic, coordinated validation and documentation strategy.

For CE-marking manufacturers and clinical laboratories operating under Article 5(5), IVDR demands structured validation, clear documentation, and lifecycle management. For NGS-based assays, compliance becomes even more demanding due to scientific, technical, and operational intricacies.

Key Challenges in IVDR Compliance for NGS

1) Complex Gene Panels & Variant Diversity

NGS panels often include multiple genes and variant types, each with distinct performance characteristics. You must demonstrate analytical performance—sensitivity, specificity, LoD, and robustness—per variant class. This tailoring increases the scale and complexity of testing.

2) Defining a Clear Intended Use

A precise, testable intended purpose statement anchors the program. Define analytes, clinical context, sample types, output format, and role in patient care. Any ambiguity risks misclassification or validation gaps.

3) Scientific Validity Across Many Analytes and Conditions

Establishing scientific validity grows challenging when one test targets dozens or hundreds of genes. Under IVDR, link each analyte to a clinically relevant condition. That linkage often requires extensive literature review, database referencing, and written justification for inclusion.

4) Clinical Performance Evidence

With broad genomic scope, comprehensive clinical studies may be infeasible. A pragmatic approach combines routine diagnostic data, published literature, and a clear link to Post-Market Performance Follow-up (PMPF) plans to support claims over time.

5) Complex Bioinformatics Pipelines

Bioinformatics sits at the core of NGS diagnostics. Validate every step—from base calling to variant annotation. Implement version control, clear revalidation triggers, and change management to maintain consistent performance after software updates.

6) Use of Third-Party Reagents and Instruments

NGS workflows often incorporate off-the-shelf reagents and platforms not originally CE-marked as part of the IVD system. Document compatibility, performance, and traceability of third-party components to meet IVDR expectations.

7) Labelling Without a Physical Device

Many NGS assays function as software-driven services or LDTs without a packaged device. You still must meet Annex I labelling and Instructions for Use (IFU) requirements—even without physical labels or packaging.

How MDx CRO Supports Your IVDR Journey

MDx CRO brings specialized expertise to guide NGS programs through IVDR across the full lifecycle:

Gap Assessments: Identify regulatory shortfalls and prioritize remediation.
Performance Evaluation Plan (PEP): Craft PEPs that balance analytical rigor with operational feasibility.
Analytical Study Oversight: Design statistically robust studies tailored to complex panels.
Bioinformatics Validation: Map and validate each software component under IEC 62304 and ISO 13485.
QMS Integration: Build audit-ready documentation, risk management, and traceability.
PMS & PMPF Strategies: Establish real-world evidence systems that sustain compliance and support clinical claims.

Conclusion

Achieving IVDR compliance for NGS assays poses a multi-dimensional challenge that blends regulatory discipline with scientific depth. From defining intended use to managing software changes and clinical claims, every step benefits from clarity, structure, and foresight.

MDx CRO partners with diagnostics developers and clinical laboratories to turn regulatory complexity into actionable validation strategies—accelerating time to market while protecting long-term compliance and patient safety.

Written by:

Marketa Svobodova, PhD

Regulatory Director, Precision Medicine

Expert in Precision Medicine, NGS & CDx, combining technical and regulatory expertise to guide IVDs through CE certification.

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The future of in vitro diagnostics

MDx CRO co-authors Journal of Liquid Biopsy paper on EU–US collaboration for IVDR-ready liquid biopsy validation

August 21, 2025

MDx CRO is proud to have contributed to the peer-reviewed article, “BLOODPAC’s collaborations with European Union liquid biopsy initiatives,” published in The Journal of Liquid Biopsy (Vol. 10, Article 100321; open access). The paper outlines practical pathways to align analytical validation, clinical performance evidence, and data standards that can accelerate European adoption of liquid biopsy under IVDR.

Carlos Galamba (CEO, MDx CRO) is listed among the authors, contributing European IVDR and clinical evidence expertise to this multi-stakeholder effort.

What the paper delivers (and why it matters)

Convergence on validation & evidence: It maps BLOODPAC’s US-developed minimum technical data elements and analytical validation protocols to EU needs—supporting more consistent clinical performance packages for IVDR submissions.
Data standards for reproducibility: The paper emphasizes fit-for-purpose standards and pre-competitive data sharing to improve comparability across clinical research for liquid biopsy, from cfDNA/ctDNA assay development to clinical use.
Practical EU–US collaboration: It proposes guidance and collaboration routes that can reduce variability across Member States and shorten time to patient access—without compromising IVDR rigor.

Read the Article (open access)

A broad coalition behind the work

The author affiliations span leading precision-medicine organizations and networks, including MDx CRO, Labcorp, Tempus AI, Natera, Exact Sciences, AstraZeneca, GSK, Bristol Myers Squibb, Johnson & Johnson, MSD, Thermo Fisher Scientific, TECAN, IQN Path, ELBS, EUCOPE, ISLB, Cancer Patients Europe, and BLOODPAC—a clear reflection of the field’s momentum toward shared, usable guidance.

Author list from the Journal of Liquid Biopsy paper showing MDx CRO (Spain) among affiliations

MDx CRO’s contribution and perspective

Through our CEO, Carlos Galamba, MDx CRO contributed to this multi-stakeholder paper outlining practical EU–US collaboration to accelerate liquid biopsy adoption under IVDR. Our perspective aligns with the paper’s focus on:

IVDR-first evidence architecture that cleanly links intended use → analytical validation → clinical performance requirements for ctDNA/cfDNA assays.
Harmonized validation expectations by mapping BLOODPAC frameworks and data elements to EU evidence needs, supporting consistent submissions.
Clearer regulatory narratives that connect validation outcomes to performance claims and real-world clinical implementation.

“This contribution reflects MDx’s commitment to turning shared frameworks into credible, IVDR-ready evidence that speeds responsible patient access” – Carlos Galamba, CEO

For IVD developers: immediate takeaways

Think trans-Atlantic. Where appropriate, re-use US learnings and BLOODPAC frameworks to reduce duplication—while meeting EU requirements.

Design for IVDR from day zero. Lock pre-analytical variables and analytical validation plans that ladder to clinical performance claims.

Adopt shared data elements. Standardized data models future-proof submissions and enable cross-study comparisons for regulators and payers.

How we execute: turning frameworks into IVDR-ready evidence

1) Study architecture (IVDR-first)

We design from intended use → analytical validation → clinical performance so claims, endpoints, and statistics line up from day one. For liquid biopsy (cfDNA/ctDNA), we predefine fit-for-purpose metrics (e.g., LoD/LoQ, precision, interference) and clinical endpoints (e.g., PPA/NPA, sensitivity/specificity).

2) Multisite execution (ISO 20916 aligned)

Feasibility and qualification of sites/labs, standardized pre-analytical controls (collection tubes, processing windows, storage), specimen logistics and chain-of-custody, risk-based monitoring, and documented deviation/CAPA management across centers.

3) Data you can trust (eCRF + eTMF)

We build validated eCRFs, enforce edit checks and audit trails, and maintain a complete eTMF/regulatory binder. Data dictionaries align with study objectives and, where appropriate, community data elements used in clinical research for liquid biopsy.

4) Analytical validation to clinical performance—without gaps

We run or coordinate liquid biopsy validation workstreams (method comparisons, reproducibility, cross-site concordance) and transition seamlessly into clinical performance studies so the evidence package is coherent under IVDR.

5) Reporting & regulatory narrative

IVDR-compliant documentation (Analytical Performance Report, Performance Evaluation Plan/Report, study reports), plus clear narratives that connect results to performance claims and labeling.

6) Governance & quality

Project governance with milestone dashboards, risk logs, vendor oversight, and audit-ready files under an ISO-driven clinical QMS.

Outcome: faster, cleaner submissions for IVDR liquid biopsy validation—and evidence that stands up to scrutiny.

Plan a study? Let’s map your assay’s intended use to the analytical validation and clinical performance evidence you’ll need.

Contact MDx today

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IVDR Performance Studies and the ISO 20916:2024 Revision

April 2, 2024

ISO 20916: Introduction

ISO 20916, “Clinical performance studies using specimens from human subjects – Good study practice” was first published in 2019 and recently released as EN ISO 20916:2024 (European Standard) at the end of March 2024, harmonizing IVDR Performance Studies with this latest revision.

In the rapidly evolving landscape of in vitro diagnostic (IVD) medical devices, maintaining the highest standards of safety and performance is paramount. ISO 20916 stands as a cornerstone in this endeavor, providing a framework for the quality and reliability of IVDs used in clinical performance studies employing human subject specimens.

This standard encapsulates comprehensive practices for planning, designing, conducting, recording, and reporting clinical performance studies for IVD devices. It lays down the foundational principles and specifies general requirements aimed at assessing clinical performance and safety for regulatory purposes. It has been meticulously designed to ensure that IVDs meet stringent criteria, thereby safeguarding public health and enhancing patient outcomes. It is intended to aid regulatory compliance, ensuring studies yield robust, ethical, and reliable results.

MDx will host a live free webinar on “Preparing for IVDR Clinical Performance Studies under ISO20916 and the new annex ZA” on the 30th April 2024 at 5pm CET. Register here.

The importance of Annex ZA of ISO 20916:2024 in IVDR performance studies

At the end of March 2024, the IVD community witnessed a significant milestone with the publication of a new revision of ISO 20916 which harmonizes IVDR performance studies. While the standard was already referenced in the text of the IVDR, this revision is particularly notable for the inclusion of Annex ZA, which finally harmonizes the standard with the In Vitro Diagnostic Regulation (IVDR) (Regulation (EU) 2017/746).

This harmonization of performance studies marks a critical step in aligning the standard with the comprehensive requirements set forth by the IVDR, thus facilitating a more streamlined regulatory pathway for IVD manufacturers. The significance of Annex ZA cannot be overstated. It bridges the gap between ISO 20916 and the IVDR, providing a clear and actionable framework for manufacturers to achieve compliance.

The text of ISO 20916:2019 has been approved by CEN (the European Committee for Standardization) as EN ISO 20916:2024 without any modification. This inclusion is a strategic enhancement, reinforcing the standard’s relevance and applicability in the regulatory landscape.

Note: As of the date this article was written, the official recognition of ISO 20916:2024 as an IVDR harmonized standard for clinical performance studies in the European Union’s Official Journal was awaiting confirmation.

Success in IVD Clinical Performance Studies with MDx CRO

At MDx CRO, we navigate the complexities of IVDR and the latest ISO 20916 revision for in vitro diagnostic (IVD) studies with unmatched expertise. Our commitment to rigorous clinical operations ensures that every clinical performance study meets all regulatory standards, incorporating strategic risk management and adaptability for maximum compliance and integrity.

Partnering with us offers manufacturers a significant advantage, rigorously evaluating IVDs to ensure adequate performance and safety, a critical component of regulatory approvals.

Choose MDx CRO for excellence in IVD clinical performance studies, driving success and enhancing patient outcomes. Contact us for a discussion today!

Highlights from Annex ZA include:

Presumption of Conformity: Compliance with the normative clauses of ISO 20916, as specified in Table ZA.1, confers a presumption of conformity with the corresponding GSPRs of the IVDR. This presumption is a testament to the robustness of the standard in meeting regulatory expectations.
Definition Clarification: Where differences arise between definitions in ISO 20916 and those in the IVDR, Annex ZA ensures clarity by highlighting these differences. The annex prioritizes the definitions set out in the IVDR, underscoring the regulation’s primacy.
Risk Management Alignment: The annex emphasizes the necessity of aligning the risk management process in EN ISO 20916:2024 with the IVDR. This alignment ensures that risks associated with IVDs are “reduced as far as possible”, in accordance with the regulation’s stringent requirements. In addition, ISO 20916 does not include foreseeable misuse in the risk management process, as required by IVDR.
Manufacturer’s Policy on Acceptable Risk: Annex ZA clarifies that the manufacturer’s approach to determining acceptable risk must adhere to specific GSPRs (i.e. 1, 2, 3, 4, 5, 8, 10, 11, 13, 15, 16, 17, 18 and 19) outlined in the IVDR. Furthermore, when reducing risks, sponsors, CROs, manufacturers and other stakeholders should note that while ISO 20916 does not include user training as a risk reduction measure, this is indeed allowed under IVDR.

Synergies between ISO 20916 and IVDR:

IVDR clinical performance parameters: Generally aligned between ISO 20916 and IVDR, however note that ISO 20916 does not mention “expected values in normal and affected populations” as a clinical performance parameter.
Ethical considerations: Generally aligned but ISO 20916 is a lot more prescriptive when compared to IVDR, defining ethical considerations and responsibilities for all parties involved, including principal investigators and sponsors.
Measures to minimise bias in study design: ISO 20916 further defines specific areas that should be considered when avoiding bias, including population bias, bias in the test protocol, bias in the reference measurement procedure, etc.
Site qualification: ISO 20916 provides a more detailed framework for site qualification, covering several criteria, including investigator qualifications, adequate resources and facilities, validated equipment , lab’s quality management system etc.
Clinical performance study report (CPSR): ISO 20916 is in general a lot more prescriptive on the contents of the clinical performance study report. Additional requirements are provided for interventional and other performance studies involving risks to the subjects.
Comparator devices used in an IVD performance study: Generally aligned, but ISO 20916 defines further how comparator IVDs should be listed, including their commercial name, manufacturer and catalogue number for example.
Investigators Brochure (IB) for Annex XIV studies: both IVDR and ISO 20916 are aligned. Annex C in ISO 20916 is dedicated to the contents of the IB. In addition ISO 20916 is a lot more prescriptive than IVDR on requirements related to risk management and risk-benefit analysis that need to be described in the CPSP and IB.

Differences to be aware of:

Differences in Annex XIV studies (and IVDR article 58): The definitions of an Annex XIV study in IVDR (i.e. interventional and other performance studies involving risks to the subjects) are different from ISO 20916. Although Annex ZA considers both the standard and regulation to cover the same elements and therefore being aligned, the description of what is in essence an Annex XIV study is different when we look at the detail. For example, the IVDR recognizes surgically invasive sample taking as being an Annex XIV study, while ISO 20916 does not use this terminology.
Adverse events: Although both IVDR and ISO 20916 are considered aligned, there are differences in the categorization of adverse events occurring in clinical performance studies. ISO 20916 provides two main types of events: non-device-related and device-related, and further categorizes this into non-serious and serious, anticipated, and non-anticipated. The IVDR is not as prescriptive in this area.
Clinical performance study plan (CPSP): ISO 20916 is more prescriptive on the specimen details to be listed in the CPSP, including their storage. In addition, ISO 20916 does not require reference to the current state of the art in diagnosis and/or medicine, whereas this is a requirement from IVDR. Last but not least, ISO 20916 has specific requirements for the CPSP synopsis.
Monitoring plan: ISO 20916 is a lot more prescriptive on the requirements for the monitoring plan, including qualification and training of monitors. According to ISO 20916 sponsors can also develop a rationale for remote monitoring. In addition, whereas IVDR requires that sponsors appoint a monitor independent of the investigation site, this point is not mandated by ISO 20916.
Informed Consent: A lot more detail is provided in ISO 20916 when compared to IVDR. The standard offers a detailed framework for obtaining informed consent.

Who Benefits from EN ISO 20916:2024?

Manufacturers of in vitro diagnostic medical devices
In vitro diagnostic clinics and laboratories
Test centres for in vitro diagnostic medical devices
Regulatory authorities
IVDR Notified Bodies
IVD Clinical research organizations (CROs)
Investigators and sponsors

Advantages of Adopting EN ISO 20916 for IVD Performance studies

Robust Results: It ensures high-quality, accurate, and reliable data generation, pivotal for safe healthcare decisions.
Ethical Standards: It upholds the rights, safety, dignity, and well-being of study subjects.
Study Planning and Conduct: It facilitates the meticulous planning and execution of IVD performance studies, ensuring regulatory and ethical compliance alongside scientific validity.
Compliance and Clarity: It provides a framework for compliance with IVDR, clarifying roles and responsibilities of all parties involved.
Risk Management: It emphasizes subject safety, especially regarding specimen collection risks, and ensures data integrity.

Implications for IVD Performance Studies and CRO Services

The integration of ISO 20916 with the IVDR, highlighted by the inclusion of Annex ZA, significantly transforms IVD clinical performance studies and CRO operations. This crucial alignment demands a comprehensive revision in study design, execution, and reporting methodologies, highlighting the importance of compliance with the unified ISO 20916 and IVDR standards. It emphasizes the need for robust quality and risk management systems and ethically responsible study development.

This evolution signifies more than standard adherence; it represents a commitment to elevating IVD performance and efficacy in line with the highest EU regulatory standards. It requires IVD stakeholders, including CROs, sponsors and manufacturers, to deeply understand and agilely apply these standards, not only for compliance but to set new quality and safety benchmarks in diagnostics.

This commitment is fundamental to advancing patient care and public health, marking a significant step forward in regulatory compliance and industry excellence.

Since its foundation, MDx CRO has consistently used ISO 20916 as the benchmark for all our IVD clinical performance studies. The release of Annex ZA and its harmonization with IVDR reinforces our status as the leading CRO for IVD clinical performance studies.

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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FDA Laboratory Developed Tests (LDTs) Regulation

October 4, 2023

FDA’s new LDT regulation underscores the vital role of IVD CROs in compliance and safety. Phased over four years without grandfathering, it highlights the necessity for IVD CROs’ regulatory expertise and their key role in aligning LDTs with stringent standards, marking a significant shift in the IVD landscape.

Introduction

The Food and Drug Administration (FDA) recently released a groundbreaking proposed rule on September 29, 2023, aiming to transform its existing approach toward Laboratory-Developed Tests (LDTs). This paradigm shift directly impacts In Vitro Diagnostic products (IVDs) and their regulation. The proposed rule presents a layered plan for LDTs, phasing out FDA’s longstanding policy of enforcement discretion. For stakeholders in the IVD sector, including clinical laboratories and LDT manufacturers, the implications of this proposed rule are monumental.

Key Points to Consider as the FDA regulates LDTs

Modification to IVD Definition: The FDA aims to explicitly categorize LDTs as IVDs within the scope of 21 CFR Part 809.3, thus making them subject to FDA’s medical device regulations, including premarket review.
Phased Implementation: The FDA proposes to gradually roll back its enforcement discretion policy for LDTs, segmenting the regulatory shifts over five distinct stages across a four-year period.
No Grandfather Clause: Unlike previous considerations, the new proposal doesn’t plan to “grandfather” existing LDTs. Public commentary on this subject is invited.
Test Exemptions: Specific test types, such as forensic and human leukocyte antigen tests, are marked for exemption from enhanced regulatory oversight.
Comment Period: Stakeholders have until December 4, 2023, to submit their feedback on the proposed rule.

Background on FDA Regulation for LDTs and IVDs

IVDs have traditionally been subject to rigorous regulatory scrutiny under various heads:

510(k) premarket notification or premarket approval (PMA)
Quality system regulation
Medical device reporting
Registration and listing
Labeling

These IVDs also fall under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). LDTs, a specialized category within IVDs, have long operated under enforcement discretion, essentially receiving less stringent oversight. This approach historically aligned with the perception of LDTs as low-risk products, but the proposed rule acknowledges the evolved complexity and widespread use of LDTs in modern healthcare.

The Evolving Landscape of LDTs

Over the past 50 years, the role of LDTs has changed dramatically, making the FDA regulation of Laboratory Developed Tests increasingly crucial. Their growing prevalence and the technical sophistication involved have prompted calls for stronger regulatory oversight. These significant developments have culminated in the FDA’s renewed perspective on LDTs. Shedding its previous stance of general enforcement discretion, the FDA Laboratory Developed Tests Regulation now aims to redefine LDTs broadly, addressing potential regulatory gaps and emphasizing the need for robust public health protection.

The Road Ahead: Implications and Recommendations

The phased implementation approach impacts various aspects of medical device regulation:

Medical Device Reporting: Will be the first area where enforcement discretion will cease.
Quality Systems: Expected to come under scrutiny three years after the final policy is published.
Premarket Review: To be phased in 3.5 to four years after the final policy, impacting high-risk IVDs first and then trickling down to moderate-risk and low-risk IVDs.

Given these imminent changes, clinical labs offering LDTs must prepare for enhanced regulatory compliance and for increased FDA regulation of Laboratory developed tests. These labs should develop protocols for both analytical and clinical validity, ensuring alignment with new regulatory expectations.

Synergies with the EU’s IVDR roll-out

In Europe, a similar regulation, the In Vitro Diagnostic Regulation (IVDR), is being phased in, emphasizing the importance of compliance for in house developed tests. Under IVDR, laboratories must ensure that their Technical Documentation and Quality Management System are up-to-date and comply with the regulation and the national law. Failure to comply with the IVDR can result in serious consequences, including fines, loss of accreditation, and even closure of the laboratory.

Furthermore, laboratories that develop in-house IVDs will be required to comply with similar requirements for manufacturing as commercial IVD manufacturers. This means that laboratories must ensure that their IVDs meet high standards for safety and performance, which can only be achieved through rigorous testing and validation.

It is important to note that the IVDR specifically includes in-house developed tests, including LDTs and CE marked IVDs modified by laboratories. If an equivalent CE marked device is available on the market or IVD product is manufactured at an industrial scale, the laboratory cannot use exemption for LDT´s provided in the IVDR (Article 5.5) and must CE mark the IVD. MDx CRO has recently published an article assessing the impact of the IVDR on LDTs.

Conclusion: An Industry in Transition

As specialists in quality, regulatory, and clinical consultancy focused on IVDs, MDx CRO advises stakeholders to take proactive measures in anticipation of these sweeping regulatory changes. Judicial challenges and public feedback could alter the timeline for the FDA to start regulating LDTs, but there’s no doubt that enhanced regulation of LDTs is on the horizon, already in full force in Europe.

Comments on the Proposed FDA Rule should be submitted by December 4, 2023, to help shape this crucial regulatory development. It is an opportune time for the industry to engage in open dialogue and to prepare for the inevitable changes that lie ahead.

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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MDx: Your Dedicated CRO for IVD Clinical Studies in the EU

August 24, 2023

Introduction

In the rapidly evolving world of in vitro diagnostics (IVD), manufacturers are increasingly understanding the need for rigorous clinical performance studies. Such studies form the backbone for ensuring the safety, efficiency, and overall market readiness of IVD devices. With the European Union’s (EU) stringent regulatory environment, conducting these studies requires expertise and precision. That’s where MDx CRO, a trusted name in IVD Contract Research and regulatory consulting, stands out.

Why are IVD Clinical Studies Imperative?

Evidence-based Decision Making: Clinical performance studies furnish the data that can prove the diagnostic accuracy, precision, and utility of IVD devices. They help manufacturers refine their offerings and justify their product claims.
Regulatory Adherence: Ensuring compliance with the EU’s In Vitro Diagnostic Regulation (IVDR) and standards like ISO 20916 is non-negotiable. Clinical studies often form the bedrock in gaining these credentials and opening up the European market.

Navigating the Challenges with MDx CRO

Whether you’re a fledgling startup or an established IVD giant, challenges like site selection, study design, effective monitoring, and regulatory adherence can be daunting. This is where MDx CRO can be your guiding light:

Proven Expertise: With its legacy in the IVD realm and former Notified Body experts on board, MDx CRO offers unparalleled insights into effective study design, ensuring manufacturers derive actionable insights every time.
Network of Clinical Sites: Owing to its years in the industry, MDx CRO has built strong affiliations with leading clinical sites, guaranteeing timely and efficient study conduct.
Regulatory Insight: Navigating the IVDR and ISO 20916 maze becomes simpler with MDx CRO’s regulatory consulting wing, which ensures manufacturers always stay on the right side of the law.
End-to-End Monitoring: With a keen focus on detail, MDx CRO ensures every study stays on track, protocols are maintained, and data integrity remains uncompromised.

Why MDx CRO?

Simply put, MDx CRO isn’t just a service provider – it’s a partner in your IVD journey. Our seasoned team understands the unique challenges IVD manufacturers face, making them an indispensable asset in your product’s journey from concept to the European market.

Conclusion

IVD clinical studies, while challenging, present a golden opportunity to IVD manufacturers to rigorously validate their product’s claims. In the intricate web of EU regulations, manufacturers need more than just expertise; they need a partner. And who better than MDx CRO, which has consistently demonstrated excellence in study design, monitoring, and ensuring complete regulatory compliance? Choose MDx CRO, and let’s work together to bring transformative and reliable IVD devices to the EU market.

FAQs about IVD Clinical Studies and MDx CRO:

What are IVD Clinical Studies?
- IVD clinical studies refer to rigorous research and evaluations conducted to determine the safety, efficiency, and overall performance of in vitro diagnostic (IVD) devices.
Why are IVD Clinical Studies important in the EU?
- The EU has stringent regulatory requirements. IVD clinical studies provide the necessary evidence to support product claims, ensuring compliance with the EU’s In Vitro Diagnostic Regulation (IVDR) and international standards like ISO 20916.
What challenges can manufacturers expect while conducting IVD studies in the EU?
- Manufacturers may face challenges like site selection, creating an effective study design, regular study monitoring, and ensuring compliance with EU regulations and standards.
How does MDx CRO help with these challenges?
- MDx CRO offers expertise in study design, has affiliations with top clinical sites, provides regulatory consulting for EU standards, and ensures end-to-end study monitoring to maintain the quality and integrity of data.
Is MDx CRO suitable for both startups and established manufacturers?
- Absolutely! Whether you’re a startup entering the IVD market or a seasoned manufacturer, MDx CRO’s tailored solutions cater to the unique needs of every client.
How does MDx CRO ensure compliance with the IVDR and ISO 20916?
- MDx CRO boasts a regulatory consulting wing with deep knowledge of IVDR and ISO 20916, ensuring manufacturers receive accurate guidance and assistance throughout their IVD device’s journey to the market. Our team of former Notified Body experts on board help design studies that meet CE mark expectations
What advantages does MDx CRO offer in terms of site selection for IVD studies?
- With its extensive experience and industry connections, MDx CRO has built relationships with leading clinical sites for a variety of technologies and clinical applications, ensuring timely and efficient study initiation and execution.
How does partnering with MDx CRO impact the success rate of IVD devices in the EU market?
- With MDx CRO’s comprehensive services, from design to monitoring and regulatory guidance, manufacturers enhance their chances of a successful and compliant IVD product launch in the EU.
Where can I learn more about MDx CRO’s success stories or case studies?
- It’s best to reach out to MDx CRO directly or visit our website for detailed testimonials, case studies, and more insights into our work.

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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