EU Reference Laboratories under IVDR: What Class D Manufacturers Must Know

September 6, 2024

In this article, we look at how the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 reshapes oversight for the highest‑risk IVDs. One of its most important elements is the creation of European Union Reference Laboratories (EURLs). These laboratories play a central role in ensuring the safety and performance of Class D devices. Article 100 defines their mission, and the Commission has since issued detailed implementing rules that explain how EURLs must be organised, resourced, and supervised.

For manufacturers, particularly those developing Class D assays, these requirements matter. EURLs can influence performance verification, batch testing, and overall timelines. Understanding when their involvement is triggered, and what they actually do, is essential for planning a realistic and compliant development pathway.

The Legal Backbone of EU Reference Laboratories IVDR

EU Reference Laboratories (EURLs) are a central element of the IVDR oversight framework. Article 100 IVDR establishes their mandate, defining their tasks and the criteria they must meet. These rules form the legal foundation for how the EU evaluates the highest‑risk IVDs.

Two implementing regulations complete this framework. Commission Implementing Regulation (EU) 2022/944 sets out the detailed requirements EURLs must fulfil—covering personnel competence, equipment and reference materials, quality management systems, organisational structure, confidentiality, impartiality, outsourcing controls, accreditation, and ongoing compliance verification. A second act, Commission Implementing Regulation (EU) 2023/2713, designates the first EURLs and confirms the date from which they apply: 1 October 2024.

What EU Reference Laboratories Check for Class D Devices

Under the IVDR, certain Class D devices require EURL involvement. For these devices, EURLs independently verify performance claims and conduct batch testing as part of the conformity assessment. This adds an additional scientific check (beyond the notified body review) to confirm analytical performance and support lot release where required.

For manufacturers, this means planning ahead. Performance panels, reference materials, sample availability, and timelines must align with EURL capacity and testing requirements.

Key Requirements Defined for EU Reference Laboratories

The 2022/944 implementing act translates Article 100(4) into concrete operational obligations. To be designated, EURLs must demonstrate:

Competent and independent personnel
Fit‑for‑purpose equipment, specimens, control and reference materials
Compliance with relevant international standards and best laboratory practices
Robust organisational and administrative structures
Confidentiality and data‑protection safeguards
Clear independence and conflict‑of‑interest controls
Strict oversight of any outsourced activities
Appropriate accreditation
Continuous verification of compliance, including Commission audits and the possibility of suspension if requirements are not met

These criteria ensure that EURLs maintain scientific integrity and high analytical standards.

Timeline and Transition for EURL Involvement

With the publication of Implementing Regulation 2023/2713, designated EURLs become operational from 1 October 2024. From that date, any new conformity assessment application falling within an EURL’s scope is expected to route performance verification or batch testing through the designated laboratory.

Devices already under assessment or already certified before this date may follow specific transition arrangements. Manufacturers should consult their notified body to understand case‑by‑case implications.

Practical Steps for Manufacturers

To prepare for EURL involvement under the IVDR:

Align performance evaluation plans early with potential EURL panel requirements (e.g., specimen types, reference materials, pathogen/biomarker variability).
Check whether your device falls within an EURL designation scope and adjust submission timelines accordingly.
Engage your notified body to understand dossier routing, documentation expectations, and language requirements.
Monitor NB and authority communications, which often provide clear summaries as EURLs scale up their activities.

Early alignment helps manufacturers avoid delays and navigate this additional scientific review step efficiently.

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MDCG 2020-16 Rev.3 classification rules

July 9, 2024

MDCG 2020-16 Rev.3 classification rules provide essential guidance on how to classify in vitro diagnostic medical devices (IVDs) under the EU IVDR. The latest revision enhances clarity, addresses known ambiguities, and strengthens consistency in how Annex VIII classification rules are applied. For manufacturers, understanding these updates is critical to ensuring correct classification, smoother conformity assessment, and regulatory compliance.

This article covers two areas:

the key updates introduced in Rev.3, and
how the guidance applies to major IVD categories, including Companion Diagnostics (CDx), Next‑Generation Sequencing (NGS), self‑testing, and Near‑Patient Testing (NPT).

Key Updates in MDCG 2020-16 Rev.3 classification rules

New Definition of “Kit”

Rev.3 introduces a formal definition of a kit:
A set of components packaged together and intended for a specific IVD examination or part of it.
This definition improves consistency in how kit-based products are classified.

Rule 3(a) – Updated Examples

Monkeypox Virus has been added to the list of organisms under this rule, reflecting current public‑health priorities.

Rule 4(a) – Clarifications for Self‑Testing IVDs

Rev.3 provides detailed guidance for the classification of self‑testing devices:

Devices for detecting pregnancy, fertility, cholesterol, glucose, erythrocytes, leukocytes, and bacteria in urine remain Class B.
Devices detecting both a Class C marker and an exception marker are Class C, following implementing rules 1.8–1.9.
Devices meeting the criteria under rules 1.8–1.9 can be Class D, including self‑tests for HIV from fingerprick blood.

Information Society Services

Devices used within online services are considered self‑testing devices only when the lay user performs part of the testing procedure.
Specimen-only actions (e.g., stabilizing or collecting the sample) do not make a device self‑testing.

Standalone Specimen Receptacles

Specimen-only collection kits offered online are not classified as self‑testing.

Examples in Rev.3

Glucose meters/strips for capillary blood → Class C
Calprotectin tests with lay interpretation via image upload → Class C
HIV antibody self‑tests (fingerprick) → Class D

Rule 5(c) – Expanded Rationale and Examples

Definition and Classification

Specimen receptacles are defined as containers (evacuated or non‑evacuated, empty or prefilled) for the primary containment and transport of biological specimens.
They are classified as Class A, as they do not perform any analytical function.

Use in Kits

Specimen receptacles included in kits for specimen collection remain Class A, even when accompanied by non‑IVD components.

User Actions

Actions such as gargling, pipetting, or adding buffer—when required solely to maintain specimen integrity—are not considered part of the testing procedure.

Combination Use

Specimen receptacles and the subsequent IVD are classified separately under implementing rule 1.2.

Examples

Standalone urine cups, stool containers, saliva tubes, blood spot cards → Class A
Lay‑use kits for saliva or stool collection for SARS-CoV‑2 or occult blood testing → Class A

Rule 6 – Updated Example

The example for Influenza A/B now refers to a highly virulent strain rather than a non‑pandemic one.

Classification of Key Diagnostic Technologies in MDCG 2020-16 Rev.3

Next‑Generation Sequencing (NGS)

Rev.3 highlights the role of NGS across several rules:

Rule 3(f) (Companion Diagnostics) – NGS identifies variants linked to therapeutic response.
Rule 3(h) (Cancer Diagnostics) – Supports cancer staging and genomic profiling.
Rule 5(a)–(b) (General Laboratory Use) – Includes library prep reagents, PCR thermocyclers, NGS sequencers, and other instruments essential for genetic analysis.

Companion Diagnostics (CDx)

Under Rule 3(f):

CDx devices are essential for the safe and effective use of specific medicinal products. They are used to:

Identify suitable patients for targeted therapies
Detect risks of adverse reactions
Support treatment decisions before or during therapy

Examples provided in Rev.3 include:

KRAS/NRAS variant detection for colorectal cancer
PD‑L1 IHC tests for immunotherapy selection
NGS‑based CDx for multi‑gene therapy selection

A decision flowchart in Annex II helps manufacturers determine whether an IVD qualifies as a CDx.

Self‑Testing Devices (Rule 4(a))

Self‑testing IVDs must be usable by laypersons without compromising analytical performance. Rev.3 emphasizes:

Ease of use
Safety
Minimised risk of misuse

Near‑Patient Testing (NPT) Devices (Rule 4(b))

NPT devices are designed for rapid clinical decision-making in point‑of‑care settings.
Rev.3 ensures clear differentiation between self‑testing and near‑patient testing based on user type, setting, and intended use.

MDCG 2020-16 Rev.3 classification rules provide crucial clarifications that support more consistent application of the IVDR. By refining definitions, expanding examples, and clarifying rules for CDx, NGS, self‑testing, and near‑patient testing, the guidance helps manufacturers classify devices accurately and reduce regulatory uncertainty.

Written by:

Alice Toomey-Smith

Regulatory Director, IVD

Quality & Regulatory Affairs leader with global IVD expertise, guiding products to compliance across EU IVDR, FDA & beyond.

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Importing IVDs for Performance Studies | EU IVDR Guide

December 3, 2023

The In Vitro Diagnostic Medical Devices Regulation (IVDR) has introduced a stringent regulatory framework for the importation of In Vitro Diagnostic Medical Devices (IVDs) into the European Union (EU) under the IVDR. This framework imposes specific requirements on sponsors and manufacturers who intend to import IVDs for performance studies. To ensure compliance and facilitate a smooth importation process, engaging an experienced IVD CRO (Contract Research Organization) can be invaluable.

IVDR Article 19 is relevant to the importation of IVDs for performance studies in that it establishes the right of sponsors and manufacturers to import IVDs into the EU for the purpose of conducting performance studies. However, it is important to note that the IVDR also imposes certain requirements on the importation of IVDs for performance studies.

Importing IVDs for Performance Studies

The are several key requirements for importing IVDs for performance studies under EU IVDR:

Appointment of a Legal Representative: Non-EU sponsors must appoint a legal representative within the EU fro their clinical performance studies. This representative is responsible for ensuring compliance with the IVDR sponsor’s obligations , and shall be the addressee for all communications with the sponsor provided for in this Regulation. (IVDR Article 58)
Labeling Requirements: Labeling must be in accordance with the IVDR’s labeling requirements, which include information on the intended use, risks, and performance of the IVD. Specific requirements include appropriate language, symbols, and hazard indications.
Adverse Event Reporting: Sponsors and manufacturers must establish and maintain systems for reporting adverse events associated with the IVD throughout its lifecycle. This includes defining what constitutes an adverse event and adhering to specified timelines for reporting. (IVDR Article 82)
Compliance with IVDR Article 19: Ensure that the importation of IVDs for performance studies adheres to the principles of freedom of movement. (IVDR Article 19)

The Role of an IVD CRO in Importation

An experienced IVD CRO can provide comprehensive support to sponsors and manufacturers throughout the importation process, ensuring adherence to the IVDR’s requirements and streamlining the regulatory pathway.

Regulatory Expertise: IVD CROs possess in-depth knowledge of the IVDR, including staying updated on changes or updates to the regulation, and can guide sponsors and manufacturers through the complex regulatory landscape.
Labeling Review: CROs can assist in reviewing and preparing labeling in accordance with the IVDR’s requirements.
Adverse Event Reporting Procedures: CROs can assist in establishing and implementing adverse event reporting procedures that comply with the IVDR’s requirements.
Communication and Representation: CROs can effectively communicate with EU authorities, representing sponsors and manufacturers during interactions and negotiations, and act as intermediaries for any necessary correspondence.
Documentation Preparation: CROs can assist in preparing and compiling the necessary documentation, including technical files, risk assessments, and labeling.
Submission and Review Management: CROs can manage the submission process, ensuring timely and accurate submissions to EU authorities and addressing any review comments promptly.

Benefits of Engaging an IVD CRO

Engaging an IVD CRO offers several significant benefits for sponsors and manufacturers:

Reduced Regulatory Burden: CROs take on the regulatory burden, allowing sponsors and manufacturers to focus on their core research activities.
Enhanced Compliance: CROs’ expertise helps minimize the risk of non-compliance, preventing delays and potential penalties.
Streamlined Importation Process: CROs facilitate a smooth and efficient importation process, expediting the availability of IVDs for performance studies.
Reduced Costs: CROs can help optimize the importation process, minimizing unnecessary costs and maximizing resource utilization.
Access to Expertise: CROs provide access to a team of experienced professionals with specialized knowledge in IVD regulation.

Conclusion

Importing IVDs for performance studies under the IVDR requires careful consideration of the regulatory landscape and adherence to stringent requirements. Engaging an experienced IVD CRO can provide invaluable support to sponsors and manufacturers, ensuring compliance, streamlining the importation process, and ultimately facilitating the development of innovative IVDs that benefit patient care.

MDx CRO: Your Partner in importation of IVDs for performance studies

MDx CRO is a leading provider of IVD CRO services, with a proven track record of success in helping sponsors and manufacturers navigate the IVDR regulatory landscape. Our team of experts possesses in-depth knowledge of the IVDR and can provide comprehensive support throughout the importation process. With specific examples of our past successes, we demonstrate our expertise and experience in the field.

With MDx CRO as your partner, you can rest assured that your IVD importation process will be compliant, efficient, and cost-effective. Contact us today to learn more about how we can help you bring your innovative IVDs to the European market.

*MDx offers assistance with the importation of devices for performance studies. MDx’s range of services does not include acting as an economic operator importer as defined under Article 13 of the EU IVDR.

Written by:

David Tomé

President

Clinical research leader and MedTech entrepreneur with deep expertise in medical devices, IVDs & precision medicine, with global study experience.

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The Role of a IVDR Legal Representative in Clinical Performance Studies

December 3, 2023

In the field of medical device regulation, the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR) exemplifies the EU’s commitment to patient safety and high standards of device performance. Central to this regulation is Article 58, which stipulates the requirement for non-EU sponsors of clinical performance studies to appoint a legal representative within the EU. This provision is integral to ensuring these studies align with the EU’s stringent regulatory standards. This article highlights the vital role of the legal representative under Article 58 of the IVDR in ensuring compliance of clinical performance studies.

Understanding IVDR Article 58

The IVDR plays a crucial role in safeguarding the safety and performance of in vitro diagnostic medical devices (IVDs). Article 58 mandates the appointment of a legal representative in the EU for clinical performance studies initiated by sponsors outside the EU. This requirement is not just a procedural step; it is a strategic measure to ensure adherence to the EU’s rigorous regulatory framework.

Role and Responsibilities of the IVDR Legal Representative following article 58.

The legal representative serves as an essential link between the sponsor and the EU’s regulatory bodies. Their responsibilities include:

Communication Facilitator: Acting as the main contact for EU regulatory authorities, addressing questions and ensuring effective communication.
Regulatory Compliance: Ensuring that the clinical performance studies comply with all relevant IVDR requirements, encompassing ethical standards, patient safety, and data protection.
Documentation Management: Maintaining comprehensive and accurate records of the study, including protocols, reports, and patient data.
Sponsor Representation: Representing the sponsor in interactions with EU authorities and providing expert guidance throughout the study process.
Documentation Submission and Review: Assisting in the preparation and submission of necessary documentation to EU authorities for timely and thorough review.

Advantages of Engaging a IVDR Legal Representative in Clinical Performance Studies

Appointing a legal representative offers several benefits:

Regulatory Burden Reduction: They possess an in-depth understanding of the IVDR, allowing sponsors to focus on research without the complexities of regulation.
Compliance Enhancement: Their expertise ensures studies adhere to all IVDR requirements, minimizing the risk of non-compliance.
Effective Regulatory Communication: They facilitate smooth interactions with EU authorities, overcoming potential language barriers.
Risk Mitigation: Early identification and resolution of compliance issues prevent delays.
Expedited Approval Processes: Their knowledge of the regulatory landscape can accelerate the approval process, bringing IVDs to the market more swiftly.

The Intersection with ISO 20916

In the realm of in vitro diagnostic medical devices (IVDs), the intersection of the European Union’s IVDR, particularly Article 58, with ISO 20916:2019 is a pivotal point for ensuring the highest standards in clinical performance studies. ISO 20916:2019 provides a comprehensive framework for the design, conduct, and reporting of these studies, ensuring their validity, reliability, and compliance with international ethical and regulatory requirements.

This intersection is critical for several reasons:

Harmonization of Standards: ISO 20916:2019 complements the IVDR by offering an internationally recognized standard for clinical performance studies. This harmonization is particularly beneficial for non-EU sponsors required to appoint a legal representative under Article 58 of the IVDR. By aligning their studies with ISO 20916, sponsors can ensure global acceptance of their data while meeting EU-specific regulatory requirements.
Enhanced Regulatory Compliance: The legal representative’s role, as outlined in Article 58, extends to ensuring that the clinical performance studies not only comply with the IVDR but also adhere to the quality and reliability standards set by ISO 20916. This dual compliance enhances the credibility and acceptability of the study outcomes.
Quality and Safety Assurance: ISO 20916’s focus on rigorous methodology, data integrity, and ethical considerations strengthens the safety and performance evaluation of IVDs. When combined with the IVDR’s emphasis on patient safety and effective regulatory oversight, this leads to a more robust and trustworthy assessment of IVDs.
Streamlined Approval Process: Understanding and implementing the requirements of ISO 20916 can facilitate a smoother approval process within the EU regulatory framework. The legal representative’s expertise in both ISO 20916 and the IVDR can expedite the review and approval of clinical performance studies, ultimately accelerating the time-to-market for innovative IVDs.

In conclusion, the integration of ISO 20916:2019 into the IVDR framework, especially under the auspices of Article 58, represents a strategic and operational synergy. It ensures that clinical performance studies of IVDs not only meet the EU’s stringent regulatory requirements but also align with global best practices, paving the way for advanced medical technologies.

Selecting an Appropriate Legal Representative in IVD.

Choosing the right legal representative is critical for the success of clinical performance studies:

Experience: A proven history of managing IVDR clinical performance studies successfully is essential.
Expertise: In-depth knowledge of the IVDR is crucial.
Communication Skills: They should emphasize clear and consistent communication with the sponsor.
Networking Abilities: A robust network within the EU regulatory framework is advantageous for insights and connections.

Conclusion

The appointment of a legal representative under Article 58 of the IVDR is a crucial step for non-EU sponsors aiming to conduct clinical performance studies in the EU. This role is more than a regulatory requirement; it is a key element in navigating the EU’s regulatory landscape and ensuring compliance with the IVDR’s strict standards. With the appropriate legal representative, sponsors can focus on their primary objective: advancing medical science and improving patient outcomes through innovative in vitro diagnostics.

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

The FDA Laboratory Developed Tests regulation marks one of the most significant shifts in U.S. diagnostic oversight in decades. The FDA’s new rule phases in full regulation of LDTs over four years, with no grandfathering. This change elevates the importance of IVD CROs, whose regulatory and clinical expertise will be critical as laboratories adapt to stringent new requirements. The rule represents a major transformation in the U.S. IVD landscape and will reshape how laboratories develop, validate, and maintain LDTs.

Introduction

On September 29, 2023, the FDA released a groundbreaking proposed rule that fundamentally redefines how the agency regulates Laboratory‑Developed Tests (LDTs). This proposal shifts LDTs out of decades of enforcement discretion and brings them fully under the FDA’s medical device framework.

Because LDTs are a subset of in vitro diagnostic products (IVDs), the new rule has sweeping implications for clinical laboratories, manufacturers, and the broader diagnostics industry. Under the FDA Laboratory Developed Tests regulation, LDTs will now be treated like other medical devices—requiring quality systems, medical device reporting, registration, listing, and in many cases, premarket review.

For stakeholders across the IVD sector, this change is significant.

Key Points to Consider as the FDA regulates LDTs

Expanded Definition of IVDs
The FDA proposes to explicitly classify LDTs as IVDs under 21 CFR 809.3.
This means LDTs will now fall under the same requirements as traditional IVD medical devices.
Phased, Four‑Year Implementation
The FDA will remove enforcement discretion in five stages over a four‑year timeline.
Each stage introduces new regulatory obligations for laboratories.
No Grandfather Clause
The proposal does not exempt existing LDTs. All LDTs (old and new) must eventually comply.
Test Categories Exempt from Enhanced Oversight
Certain test types, including forensic tests and HLA assays, are proposed for exemption.
Public Comment Period
Stakeholders were invited to submit comments through December 4, 2023.

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

LDTs, however, historically operated under enforcement discretion, receiving minimal oversight. This approach was based on the assumption that LDTs were low risk and used primarily within single laboratories.

That landscape has changed.

The Evolving Landscape of LDTs

Over the last 50 years, LDTs have become increasingly complex, widely used, and technically sophisticated. This evolution has driven demand for stronger oversight in areas such as:

Clinical validity
Analytical performance
Manufacturing consistency
Patient safety

The new FDA Laboratory Developed Tests regulation directly responds to these gaps. By redefining LDTs and removing enforcement discretion, the FDA aims to strengthen public health protections.

The Road Ahead: Key Regulatory Impacts

The phased implementation timeline will introduce major compliance requirements:

Medical Device Reporting

The first enforcement area to take effect.

Quality Systems Regulation

Expected three years after publication of the final rule.

Premarket Review

Introduced 3.5 to four years after the final rule, starting with high‑risk LDTs and expanding to moderate-and-low risk tests.

Labs performing LDTs must begin planning now. Clinical and analytical validation, documentation systems, and regulatory processes will all require upgrades.

Alignment With Europe’s IVDR Rollout

The FDA’s new approach mirrors developments in Europe under the In Vitro Diagnostic Regulation (IVDR). The IVDR already applies strict rules to in‑house tests and LDTs, requiring:

Complete Technical Documentation
A compliant Quality Management System
Performance evaluation and validation
Adherence to Article 5.5 requirements for in‑house devices

çUnder IVDR, an LDT cannot be used if an equivalent CE‑marked test exists. This forces laboratories to justify in‑house development and meet near‑manufacturer‑level standards.

Conclusion: An Industry in Transition

As experts in IVD quality, regulatory, and clinical operations, MDx CRO encourages laboratories and manufacturers to prepare now for the FDA Laboratory Developed Tests regulation. Although legal challenges may influence the timeline, increased oversight is inevitable, and already fully established within Europe under the IVDR.

Stakeholders should submit comments to the FDA by December 4, 2023, and begin strengthening their regulatory systems immediately.

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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Monkeypox Diagnostic Test Specifications: Navigating WHO’s TPPs

August 24, 2023

WHO publishes specifications for monkeypox tests

The World Health Organization (WHO) has recently unveiled two pivotal Target Product Profiles (TPPs) for monkeypox diagnostic test specifications. As the diagnostic landscape evolves, it becomes imperative for diagnostic manufacturers to align with these international benchmarks. MDx CRO stands at the forefront as a strategic CRO and regulatory consulting partner to navigate these benchmarks with precision and compliance.

Deciphering WHO’s TPPs

The intended patient population in both TPPs are individuals suspected of monkeypox infection, including children and adults, TPP1 is tailored for NAAT (nucleic acid amplification tests) qualitative diagnostic test applications within healthcare settings and laboratories. TPP1 is directed towards laboratories or point of care facilities, such as a outpatient or STI clinics, emergency units or other settings near patient care. It mandates a test that boasts high diagnostic sensitivity (≥95%), specificity (≥97%) when compared to a reference molecular method.

Sample type: lesion material or mucosal swabs (excluding saliva).
The test’s intended user is typically laboratory personnel or a trained healthcare professional (when used near-patient).
Closed molecular systems and tests that do not require extraction prior to amplification/detection are preferred.
Test design: 2 independent target regions with at least one target that is monkeypox specific. The IFU should specify the assay’s target region.
Results should be obtained in under 4 hours and preferable under 1 hour.

In contrast, TPP2 should be used for tests that aid the diagnosis of orthopoxvirus antigens, such as qualitative lateral flow immunoassays tailored for decentralized used, including in the community, rural environments and low-resource settings. Results should be interpreted visually and/or through digital readout via smartphone. Tests should demonstrate adequate diagnostic sensitivity (≥80%), specificity (≥97%) for community based settings when compared to a reference molecular method.

Sample type: lesion material, mucosal swabs or saliva. When present, lesions are the preferred sample type.
The test should be designed for use by non-lab trained intended users.
The target analyte is the monkeypox virus antigen/protein. Tests targeting antibody detection are not acceptable.
Results should be obtained quickly in under 40 minutes and preferable under 20 minutes, a crucial feature for time-sensitive environments such as outbreak regions or remote settings

The creation of WHO monkeypox diagnostic test specifications was underpinned by a comprehensive process, involving myriad experts from fields such as science, public health, and regulation. A crucial step involved a public consultation phase, ensuring the TPPs were refined with broad feedback before finalization. This initiative by WHO is a hallmark in the trajectory of creating robust diagnostic tools for monkeypox and related orthopoxviruses.

Partnering with MDx CRO for your monkeypox test development

MDx CRO is unwavering in its commitment to support the development and clinical trials that meet monkeypox diagnostic test specifications. Our services, fortified by vast expertise, encompass areas such as meticulous IVD clinical performance study design, efficient sample collection and analysis, and stringent regulatory compliance across multiple jurisdictions, with an emphasis on CE marking under the IVDR.

While the TPPs provide an essential blueprint, the diagnostic journey also demands attention to several critical facets:

Study Populations: Defining the optimal study population is paramount. Such a population should encompass individuals potentially benefiting from the test, including those suspected of monkeypox or those at elevated risk of exposure.
Reference Standards: Leveraging appropriate reference standards ensures validation of the test’s accuracy and reliability, forming the backbone of its developmental and evaluative processes. Samples should cover a range of clinically relevant viral loads as per the reference method used.
IVD Clinical Study Design of monkeypox tests should include prospective or leftover specimens, covering a clinically relevant viral load. MDx CRO can help design and execute clinical performance studies in alignment with the WHO TPP and IVDR CE mark expectations.

With the scientific acumen and regulatory insights of MDx CRO, diagnostic manufacturers can confidently navigate the intricacies of the WHO’s TPPs and other global benchmarks.

Planning to develop an IVD monkeypox test or to conduct an EU based clinical trial? Contact us today to find out how MDx CRO can accelerate your development journey.

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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IVDR Transition: Insights from the Dutch Authority

August 11, 2023

State of play of IVDR Transition:

In the realm of in vitro diagnostics (IVD), a seismic shift is underway as manufacturers grapple with the complexities of transitioning to the new European In Vitro Diagnostic Regulation (IVDR). This transition, necessitated by advancements in technology and evolving patient safety concerns, brings both challenges and opportunities for IVD manufacturers. A recent report by the Dutch Competent Authority (IGJ) delves into the progress, setbacks, and strategies of IVD manufacturers in their journey toward IVDR compliance. Over 40% of respondents raised doubts about whether they will be able to obtain the CE marking for their IVDs before the transition periods expire.

The IGJ Report Findings:

The IGJ report sheds light on the multifaceted landscape of the IVDR transition. Manufacturers are confronted with stringent requirements that demand a paradigm shift in their approach to product development, documentation, quality assurance, and post-market surveillance. The report identifies several key challenges:

Technical Documentation Overhaul: The IVDR mandates comprehensive and meticulously documented technical files and dossiers. This demand presents a considerable challenge as manufacturers strive to align existing documentation with the new regulations. Additionally, the dynamic nature of diagnostic technologies requires continuous updates, further complicating the documentation process. Gathering of IVDR Clinical Evidence is particularly challenging for manufacturers due to lack of guidelines and international coordination. For example, application for clinical performance studies across Member States is not fully harmonised.
Certification Complexities: Acquiring the necessary certification from Notified Bodies is a crucial step in the IVDR transition. However, the IGJ report underscores the intricate nature of the certification process, involving rigorous assessments and evaluations. This complexity can lead to delays in bringing products to market. Notified Bodies have reported delays in the certification process due to lack of information in the IVDR technical documentation and also lack of structure and clarity in the file.
Post-Market Surveillance Emphasis: The IVDR places increased importance on post-market surveillance (PMS) and vigilance. Manufacturers are expected to establish robust systems for monitoring the performance and safety of their products throughout their lifecycle. This shift necessitates a proactive approach to identifying and addressing potential issues. 80% of respondents have adapted their vigilance procedures to IVDR requirements, however compliance to PMS System, PMS plan and PMPF requirements is lower, at 70% of respondents. The IGJ has declared they will promote or enforce compliance through random inspection visits.
Educational Imperative: The IGJ report emphasizes the significance of educating all stakeholders, from manufacturers to regulatory bodies, about the intricacies of IVDR compliance. Adequate training is crucial to ensure that everyone understands their roles, responsibilities, and the broader implications of the new regulation.

The Role of MDx CRO in your IVDR Transition:

Amid these challenges, MDx CRO emerges as a guiding light for IVD manufacturers. As the industry grapples with the transformative implications of the IVDR, MDx CRO stands as a stalwart partner, offering expert guidance and tailored solutions to navigate the evolving regulatory landscape.

Strategic Guidance: MDx CRO’s team of seasoned experts provides strategic advice that empowers manufacturers to make informed decisions. Transitioning to the IVDR isn’t just about compliance; it requires a forward-looking approach that considers the long-term impact on products and business strategies.

Technical Documentation Excellence: The IGJ report highlights the criticality of accurate and comprehensive technical documentation. MDx CRO’s expertise shines in this arena, aiding manufacturers in compiling technical files and dossiers that meet IVDR standards while showcasing the safety and innovation of their products.

Certification Support: With the certification process’s complexities highlighted in the report, MDx CRO’s collaborative approach becomes invaluable. By assisting manufacturers in preparing for interactions with Notified Bodies, MDx CRO streamlines the certification journey, ensuring quicker time-to-market for products. Read about our pre-submission service.

Continuous Partnership: The IGJ report’s emphasis on post-market surveillance aligns with MDx CRO’s commitment to the entire product lifecycle. Beyond the transition, MDx CRO supports manufacturers in establishing robust PMS systems, enabling them to meet ongoing compliance and safety monitoring requirements.

Knowledge Dissemination: As underscored by the report, education is pivotal in a successful IVDR transition. MDx CRO’s training and workshops empower manufacturers with the insights and understanding needed to navigate the new landscape with confidence.

Conclusions:

The IGJ report provides a comprehensive view of the challenges and advancements in the IVD sector’s transition to IVDR compliance. One message is clear, the IGJ unequivocally mandates manufacturers to expedite IVDR certification without delay. This is key to prevent peak in applications when the transition period come to an end. Within this landscape, MDx CRO emerges as a crucial enabler, equipping manufacturers with the tools, expertise, and support needed to thrive in the new regulatory era. By offering strategic guidance, technical excellence, certification support, ongoing collaboration, and knowledge dissemination, MDx CRO paves the way for compliant, innovative, and patient-centered IVD products. As the industry continues to navigate the evolving regulatory seas, MDx CRO stands as a steadfast partner in this transformative journey.

Contact our team today to discuss your IVDR transition 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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Carlos Galamba: Your Trusted IVD Consultant and IVDR Expert

August 10, 2023

Innovative medical professional specializing in MedTech advancements at MDX, focusing on accelerating healthcare innovation and improving patient outcomes through cutting-edge technology. — Carlos Galamba, CEO MDx CRO

Carlos Galamba, IVD Consultant – MDx CRO Founder

In the intricate landscape of In Vitro Diagnostics (IVD) and the evolving In Vitro Diagnostics Regulation (IVDR), one name stands out as a beacon of expertise and guidance – Carlos Galamba. With a wealth of experience spanning over 18 years in the IVD sector, Carlos is a seasoned consultant who has left an indelible mark on the world of diagnostics.

Pioneering Path to Regulatory Mastery

Carlos’s journey commenced as a biomedical scientist, setting the stage for a remarkable career journey. His trailblazing role as the first in-house clinician for IVDs at BSI (British Standards Institution), a renowned Notified Body, played a pivotal role in shaping the clinical oversight process for hundreds of diagnostics. From genetic tests to molecular assays, point-of-care diagnostics, CDx, LDTs / in-house assays, NGS and beyond, Carlos expertise is unrivaled. This groundbreaking contribution has significantly impacted how the industry approaches regulatory compliance.

Mastering the IVDR Landscape

Carlos Galamba’s expertise extends well beyond his role at BSI. His insights have positioned him as a distinguished external expert for the EU Commission, where he provides invaluable guidance in navigating the intricate IVDR terrain. His strategic acumen has propelled prominent companies like Biomerieux, Cepheid, Leica, Hologic, Abbott, Thermofisher, Werfen and more toward achieving excellence in IVDR compliance.

Guiding Innovation in IVD

At the helm of innovation, Carlos Galamba served as the Vice President of IVD Intelligence & Innovation at RQM+. His technical thought leadership encompassed an array of IVD technologies, ranging from immunoassays to more complex next-generation sequencing tests and IVD Software. Carlos’s insights have led to the development of competitive intelligence strategies that drive expansion and commercialization within the IVD consultancy sector.

A Catalyst for Regulatory Success

Carlos’s dedication to simplifying the complex is the cornerstone of his approach. His tailored solutions empower businesses to navigate the evolving regulatory landscape while gaining a competitive edge. His remarkable achievements, including leading the transition to the new EU medical device legislation (IVDR) at several companies and successfully implementing pivotal regulatory changes, position Carlos Galamba as a catalyst for transformative IVD projects.

Connect with MDx CRO for Regulatory Excellence

Whether you’re an IVD startup with ambitious goals or a global diagnostics manufacturer looking to streamline regulatory processes, Carlos Galamba’s expertise is your compass for regulatory mastery. If your company is seeking unparalleled IVD consulting, don’t hesitate to connect with Carlos and his team at MDx CRO. Together, they bring a wealth of knowledge to guide you through the complexities of IVD regulations.

Connect with Carlos on LinkedIn

In the complex landscape of In Vitro Diagnostics and the evolving IVDR framework, Carlos Galamba’s expertise continues to set the standard for regulatory excellence. His extensive experience and leadership exemplify how deep regulatory insight and practical guidance can shape successful IVD strategies and ensure lasting compliance under the IVDR.

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